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1. Introduction

cognitive and motor exercises, CM

These authors contributed equally to this work.Many studies have indicated a weakening in several areas of cognitive functioning associated with the normal ageing process. One of the methods supporting cognitive functions in older adults is dual-task training which is based on performing cognitive and motor exercises at the same time. The study aimed at examining the characteristics of dual-task training compared to single-task training in participants over 65 years of age. Sixty-five subjects took part in the study. They were randomly assigned to three groups: dual-task cognitive-motor training (CM), single-task cognitive training (CT), and single-task motor training (MT). The training program in all groups encompassed 4 weeks and consisted of three, 30-min meetings a week. Specialized software was designed for the study. The main indicators, such as orientation and planning time and the number of errors, were monitored during the whole training in all groups. The obtained results have shown that the dual-task training was associated with a significantly greater number of movement errors, but not with a longer task planning time compared to the single-task condition training. There was a decrease in the time needed to plan a path in the mazes by subjects training in the CM, CT, and MT groups. The results indicate that after each type of training, the number of errors and the time needed to plan the path decrease, despite the increasing difficulty of the tasks. The length of planning time was strongly correlated with the number of errors made by individuals in the CM group (r = 0.74, Cognitive, especially executive, and motor functions, which tend to decline with age, are important in everyday life as the performance of some of the most basic activities requires the simultaneous involvement of both types of these functions [The interference effect is defined as overlapping of similar pieces of information, which may inhibit or disrupt one another, thus making it easier to forget one or both [Research conducted on the basis of both theories shows that the IE may change and increase if the task is difficult, or it may be reduced in the course of the training [The IE reduction was also investigated in studies applying neurophysiological tests, using functional magnetic resonance (fMRI), electroencephalography (EEG), and functional near-infrared spectroscopy (fNIRS) in participants between 20 and 30 years old [In summary, performing two activities simultaneously can overload a person’s cognitive resources, causing an interference effect. However, the IE may be reduced by multitasking training. As shown by contemporary works [The cognitive mechanisms underlying the performance of two activities at the same time may explain supporting the elderly through the dual-task training. Unfortunately, the mechanism of reducing the interference effect has not been fully understood yet. Referring to the above-mentioned literature on the subject, the assumption is that the dual-task training is more cognitively demanding compared to the single-task training, consequently:The planning time will be longer, and the number of errors will be larger during the dual-task training, compared to the single-task training.The planning time will be shorter, and the number of errors will be reduced after all types of training.The main goal of this study is to answer the question of how the characteristics of dual-task training may be compared to the single-task training in the elderly.

PMC9864789

2. Materials and Methods

PMC9864789

2.1. Participants

psychiatric

Sixty-five participants (16 men and 48 women), over 65 years of age, without neurological, psychiatric, cardiological, or orthopedic diseases/disorders, moving independently, were recruited from senior community centers in Warsaw. Exclusion criteria were a score below 24 points in the Polish version of the Mini-Mental State Examination test (the Polish adaptation and standardization of MMSE [The total number of screened participants comprised 84 subjects. The participants of the study were randomly assigned to one of the three experimental groups and one control group (4 men, 16 women). Further, 58 of them completed the training (14 men and 44 women): 19 participants (5 men, 14 women) in the cognitive-motor group (4 individuals resigned), 20 (3 men, 17 women) in the cognitive group, 19 (6 men, 13 women) in the motor group (2 individuals dropped out). Six individuals dropped-out of the experimental groups due to the length of training. Only data obtained from the participants who completed the study were included in the statistical analysis. There were no training data from the control group.The mean age of the study participants was 71.2 (SD = 5.2), the number of years of education—15.3 (SD = 2.7), and the mean MMSE score was 29.1 (SD = 0.9). There were no demographic and clinical (MMSE score) differences between experimental and control groups. Detailed data are presented in All patients provided informed consent prior to inclusion. The research was completed in accordance with Helsinki Declaration.

PMC9864789

Randomization

Cognitive Motor Dual-Task Group, CM

Each examined person, after receiving a telephone notification, was randomly assigned by the project manager to one of four groups: Cognitive Motor Dual-Task Group (CM), Cognitive Task Group (CT), Motor Task Group (MT), or Control Group (C), and obtained a consecutive number from 1 to 20, in accordance with the simple randomization methodology [

PMC9864789

2.2. Procedure

CM

The participants were randomly assigned to one of three groups. The training in the CM group consisted in performing cognitive-motor tasks, the training in the CT group consisted in performing cognitive tasks, and the training in the MT group consisted in performing motor tasks. In the control group, the participants underwent two neuropsychological assessments (especially focusing on executive functions and attention), identical to the pre-test and post-test for the experimental groups, as well as the balance measurements. The control group did not participate in the training between the pre-test and post-test.After being assigned to one of the groups, the participants were informed about the research procedure, and they made an appointment for a pre-test. The post-test took place 4 weeks after the pre-test in all training groups and the control group. In the experimental groups, the meetings (10 training sessions for the CT and MT groups, 12 training sessions for the CM group, 3 times a week for 30 min) took place between the pre-test and the post-test training. A visual illustration of the training protocol has been provided in Group 1: in the dual-task training (CM), the participants planned their path through the maze and used body balancing on the posturographic platform to move through the maze.Group 2: in the cognitive training (CT), the participants planned their path through the maze and used a computer keyboard to move through the maze.Group 3: in the motor training (MT), the participants were to follow the route in the maze along the marked path, using body balancing on the posturographic platform to move through the maze.Control group: the participants not performing any exercises, neither cognitive nor motor.All participants, regardless of the training group, worked on the same cognitive material. In order to make the collected data as objective as possible, both the pre-test and the post-test were conducted by a project manager assistant other than the one responsible for the training sessions, and the project manager’s assistants had no insight into the pre-test or the training results.

PMC9864789

2.3. Research Apparatus

cognitive and motor skills, CM

Two DELL Inspiron (500 series) laptops (DELL LLC, Austin, TX, USA) with a 17.3″ screen and 2 Nintendo Wii Balance Board (Nintendo, Kioto, Japan) posturographic platforms of 30 × 50 cm, integrated for the OpenBCI services, were used in all training sessions. Moreover, an open-source DynamicCognition training on the basis of OpenBCI brain–computer interference platform (GNU GPL v3.0 license), operating with Ubuntu 14.04 software, was used. It is designed to improve planning and switching of attention during balance control exercises.The game consisted of 388 mazes (of increasing difficulty level of cognitive and motor skills) divided into 8 levels of difficulty—higher levels were characterized by a greater number of steps needed to reach the goal. Each maze board was made of 64 square areas (8 × 8). Participants were to navigate through mazes using a green ball, controlled, depending on the experimental group, either by the deviation of the feet pressure center on the posturographic platform (Nintendo Wii Balance Board) (CM and MT group) or by a computer keyboard (CT group). The participants’ task was to move the ball in such a way as to reach the green cross marking the end of the maze, without falling into the area of the “black hole” that would restart the level. After falling into the “black hole” three times, the player went back to the lower level of the task. When moving around the maze, the rules for the ball movement had to be taken into account: the ball moved in a straight line, and it moved until it hit an obstacle (walls, holes, or a cross).

PMC9864789

2.4. Measures

The Mini-Mental State Examination [

PMC9864789

2.4.1. Training Indicators

Special indicators that measured the interference effect were elaborated for the purpose of this study. The game that was created as part of this study allowed for collecting the orientation and planning time and the number of errors data.

PMC9864789

Time of Orientation and Planning

CM

In all three training groups, this indicator was related to the same time interval in seconds: from the moment the board was displayed until the first step was performed. However, due to the specificity of the training tasks, it measured slightly different functions in the CM and CT groups than in the MT group. In the MT group, the participants were to follow the route in the maze, paying attention to the marked path. In this group, the time of orientation and planning was therefore an indicator of the time needed to get to know the board—of focusing attention and of visual-spatial orientation. In the CM and CT groups, it was an indicator of the time needed to prepare for the task (as in the MT group) and plan the path through the maze. The material on which the participants worked (mazes) was the same for the CM, CT, and MT groups. In the study, the orientation and planning time was averaged for each participant and for all difficulty levels and presented separately for the three training groups.

PMC9864789

Number of Errors

CM

For the participants in the CM and CT groups, this indicator applies to a slightly different construct than in the MT group, due to the specificity of the training tasks. In the CM and CT groups, the number of errors actually indicated the errors made in the planning process, namely incorrect steps. Incorrectly performed steps are additional moves—they were counted in the form of the difference between all the steps taken in a given maze and the minimum number of steps needed to complete the maze with the correct planning of the path. Planning skills were not tested in the MT group—this indicator concerned the number of deviations from the marked path that had to be followed by tilting the body on the posturographic platform. This error may have been caused by movement or attention difficulties in seniors and was counted each time the participant leaned out on the posturographic platform and kept leaning in a different direction than the path indicated. In the study, the number of errors was averaged for each participant and all levels of difficulty, separately for each of the training groups.

PMC9864789

2.5. Statistical Analyses

In order to establish whether the data sets had a normal distribution, the Shapiro–Wilk test was used with the significance level First, the results for orientation and planning time and the number of errors indicators between the training groups were compared for 8 levels of difficulty using the Secondly, the To compare the orientation and planning time and the number of errors between all training groups and during the whole training, the In the end, the orientation and planning time and the number of errors were correlated using the

PMC9864789

3. Results

PMC9864789

3.1. Orientation and Planning Time

In the cognitive-motor and cognitive groups, the plot line had similar shapes compared to the single-motor group (The data in The data in

PMC9864789

3.2. Number of Errors

The results shown in The results shown in The results shown in

PMC9864789

3.3. Orientation and Planning Time and the Number of Errors in General

The data in The correlation data in

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4. Discussion

The study is of particular importance in the current literature because it shows the mechanism of reduction of the interference effect during dual-task training when compared to the single-task training. The novelty of this study is the analysis of the progress of dual-task and single-task training using two created indicators: orientation and planning time and number of errors. The results allow for a better understanding of the interference effect reduction mechanisms in the elderly. There were two general assumptions made on the basis of the literature, (1) that the planning time would be longer, and the number of errors would be larger during the dual-task training and that (2) the planning time would be shorter, and the number of errors would be reduced after all types of training (dual and single-tasks training).

PMC9864789

4.1. The Planning Time Will Be Longer, and the Number of Errors Will Be Larger during the Dual-Task Training, Compared to the Single-Task Training

The obtained results have shown that the training in a dual-task condition was associated with a significantly greater number of errors, but not with a longer task planning time compared to a single-task condition training.The results of this study visibly differ from the classic studies about the Stroop interference effect [

PMC9864789

4.2. The Planning Time Will Be Shorter, and the Number of Errors Will Be Reduced after All Types of Training

cognitive-motor and cognitive exercises

There was a decrease in the time needed to plan a path in the mazes among the subjects training in the cognitive-motor, cognitive, and motor groups. From the 6th level of difficulty, an increase of the required time in cognitive-motor and cognitive tasks was obtained. In the MT group, a significant reduction in the time needed to start a task was obtained on the 2nd level. There was a pronounced reduction in the number of errors made in the cognitive-motor, cognitive, and motor training. The subjects who performed cognitive-motor and cognitive exercises made fewer errors from the 6th level of difficulty. The participants training the motor tasks less frequently got off the path from the 3rd difficulty level. This result means that after all types of training, the number of errors and the planning time are reduced, but it happens at different moments during the training.These results are consistent with the current literature, where in tasks based on the Stroop interference effect, the elderly subjects obtained shorter execution times and made fewer errors [The results indicate that after all types of training, the number of errors and the time needed to plan the path decreases, despite the increasing difficulty of the tasks. Depending on the type of training, the planning time and errors are reduced at different points in the training.

PMC9864789

4.3. General Discussion

cognitive-motor and cognitive training

In comparison to the neuropsychological studies mentioned above, the dual-task training presented in this paper was more cognitively demanding. The interference effect was visible, especially at the beginning of the training and it was present up to the 6th difficulty level, after that it decreased. In the context of future research, an interesting one seems to be assessing the similarities of the learning effect for cognitive-motor and cognitive training. Perhaps the balance training was of a slight difficulty for the participants who practiced cognitive-motor tasks and the cognitive-motor and cognitive groups in fact worked on the same skills. Additionally, no significant effect of exercise training in the motor group was demonstrated. On the other hand, in the dual-task training, an increased number of errors was observed, and even a slight “strain” with the task that followed caused an interference.The obtained results will have significant applicability in practice. The dual-task training could be one of highly effective, additional methods of supporting older adults in terms of their cognitive and physical activity. What is more, it may become a possible means of providing rehabilitation, thus leading to maintaining their independence in everyday life.

PMC9864789

4.4. Limitation of the Study

Several limitations of the study should be considered. One of these limitations is the sample blinding method. In the discussed paper, the double-blind standard was not maintained. The project assistants knew to which groups the participants were assigned. Another limitation is the cognitive material (the maze game with increasing difficulty) used in the training sessions could be repetitive and monotonous for participants, possibly implicating reduced motivation. The last limitation would be the participants group. The participants were a group of healthy older adults, mostly women (73% of participants), seeking some cognitive activity.

PMC9864789

Author Contributions

Conceptualization, J.W. and E.Ł.; methodology, J.W.; software, A.C..; validation, J.W., A.C. formal analysis, A.C.; investigation, A.O.; resources, A.O.; data curation, A.C.; writing—original draft preparation, J.W. and A.O.; writing—review and editing, E.Ł.; visualization, A.C.; supervision, E.Ł.; project administration, J.W.; funding acquisition, E.Ł and J.W. All authors have read and agreed to the published version of the manuscript.

PMC9864789

Institutional Review Board Statement

The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethical Committee of Faculty of Psychology the University of Warsaw, 26 January 2016.

PMC9864789

Informed Consent Statement

Informed consent was obtained from all subjects involved in the study.

PMC9864789

Data Availability Statement

Not applicable.

PMC9864789

Conflicts of Interest

The authors declare no conflict of interest.

PMC9864789

Introduction

dementia

Edited by: Morteza Arab-Zozani, Birjand University of Medical Sciences, IranReviewed by: Elena Olariu, Newcastle University, United Kingdom; Mahin Gheibizadeh, Ahvaz Jundishapur University of Medical Sciences, IranThis article was submitted to Aging and Public Health, a section of the journal Frontiers in Public HealthThe EQ-5D is a widely used health-related quality of life (HRQoL) instrument. The recall period “today” may miss out on recurrent health fluctuations often observed in people with dementia (PlwD). Thus, this study aims to assess the frequency of health fluctuations, affected HRQoL dimensions and the impact of the health fluctuations on the assessment of health today using the EQ-5D-5L.

PMC10064342

Methods and analysis

EVENTS

This mixed-methods study will base on n=50 patient and caregiver dyads and four main study phases: (1) Baseline assessment of patients' socio-demographic and clinical characteristics; (2) caregivers self-completion of a daily diary for 14 days, documenting patient's today's health compared to yesterday, the affected HRQoL dimensions, and events that could have caused the fluctuations; (3) administration of the EQ-5D-5L as self- and proxy-rating at baseline, day seven and day 14; (4) interviewing caregivers on patient's health fluctuation, the consideration of past fluctuations in the assessment of health today using the EQ-5D-5L, and the appropriateness of recall periods to capture health fluctuations on day 14. Qualitative semi-structured interview data will be analyzed thematically. Quantitative analyses will be used to describe the frequency and intensity of health fluctuations, affected dimensions, and the association between health fluctuation and its consideration in the assessment of health today.

PMC10064342

Discussion

dementia

EVENTS

This study aims to reveal insights into the health fluctuation in dementia, the affected dimensions, and underlying health events, as well as whether individuals adhere to the recall period of health today using the EQ-5D-5L. This study will also provide information about more appropriate recall periods that could better capture health fluctuations.

PMC10064342

Trial registration

This study is registered in the German Clinical Trials Register (DRKS00027956).

PMC10064342

Introduction

Alzheimer's and Lewy body dementias, cognitive symptoms

The EQ-5D-5L is a widely used preference-based generic instrument that measures today's self-rated health-related quality of life (HRQoL) (So far, challenges in measuring HRQoL and the impact of health state fluctuations have not been well-understood. Fluctuations of predominantly cognitive symptoms have been assessed clinically for Alzheimer's and Lewy body dementias (Thus, the lack of understanding of the questionnaire and its recall period might influence the assessment of the patient's actual HRQoL status, especially in those experiencing recurrent health fluctuations (

PMC10064342

Objective

dementia

EVENTS

This study aims to (i) quantify the occurrence, frequency and intensity of health state fluctuations and underlying health events over 14 days, (ii) identify which HRQoL dimensions may be affected by these fluctuations, and (iii) evaluate if past fluctuations are considered in the assessment of health today using the EQ-5D-5L. Furthermore, if the latter is true, this study aims (iv) to determine which recall period would be more appropriate to capture health state fluctuations in dementia.

PMC10064342

Methods and analysis

PMC10064342

Study design and setting

dementia

To understand and explore the impact of health state fluctuations in dementia on the EQ-5D-5L assessment of today's health, this study will be carried out as an explorative, single-group, observational study that combines quantitative and qualitative (mixed) methods over the following four main study phases (see Questions of the semi-structured interview.After an initial socio-demographic and clinical baseline assessments of PlwD and their caregivers

PMC10064342

Participant recruitment and eligibility criteria

dementia

NEURODEGENERATIVE DISEASES, RECRUITMENT

PlwD and their informal caregiver will be recruited in the primary care setting through specifically qualified study nurses who work with general practitioners (GP), neurologists, psychiatrists and memory clinics who are in ongoing collaborations and studies with the German Center for Neurodegenerative Diseases (DZNE) at the site Rostock/Greifswald in Mecklenburg-Western Pomerania, a predominantly rural state in the north-eastern part of Germany. Study nurses will act as gatekeepers in this study as they may be perceived as trustworthy by participants due to their previous contact in other studies. Based on the means of recruitment, participants could have been included in other recently completed studies (PlwD should meet the following inclusion criteria: positively screened for dementia through the DemTect procedure (DemTect ≤ 8) (Ethical approval has been obtained from the Local Ethical Committee at the University Medicine Greifswald (Registry number BB128/21 and BB 128/21a). The overall study design is illustrated in Study procedures.

PMC10064342

Sample size

The sample size in qualitative research is driven by data saturation. However, there are no standard criteria for calculating the sample size for this type of study. Blome et al. (

PMC10064342

Data collection

EVENTS

At baseline, day seven and day 14, the EQ-5D-5L (After completing the baseline assessment, caregivers will daily self-complete a fluctuation diary for 14 days, documenting the frequency and intensity of health state fluctuations, affected dimensions, and underlying health events (see Health fluctuation diary (exemplary illustration for day 1).On day seven of the self-completion of the 14-day diary, the nurse will visit the caregiver at their home and will glance over the caregiver's documentation from day 1 to day 7. The study nurse will provide further assistance, discuss inconsistencies in the documented answers and be available for any questions about completing the diary. This could avoid entry errors and missings and, therefore, promotes the retention of protocols. Furthermore, instructions will be provided on how to fill out the diary.As an incentive for complete follow-up, the patient and caregiver receive a lump sum payment upon completion of the 14-day assessment period.Before the study roll-out, a pilot study will be implemented for

PMC10064342

Measures

PMC10064342

Health-related quality of life and clinical measures

cognitive impairment

The EQ-5D-5L (The MMSE is the most common tool for assessing the severity of cognitive impairment, categorizing participants into one of four groups of cognitive impairment: without (MMSE value ≥ 27), mild (MMSE values: 20–26), moderate (MMSE values: 10–19), and severe (MMSE values: 0–9) (

PMC10064342

Outcome measures to assess health fluctuations

dementia

EVENTS

The primary outcomes of this study are (i) the occurrence, frequency and intensity of health state fluctuations documented in the 14-day diary and by using the change in health states from day 1 to day 7 and day 7 to day 14 using the EQ-5D-5L index, the EQ-5D dimensions and the EQ-VAS, (ii) affected HRQoL dimensions, (iii) the underlying health events over time that could have affected patients' health, and (iv) the incorporation of recurrent health state fluctuations in the assessment of health today using the EQ-5D-5L.i. To assess the frequency and intensity of the health state fluctuation, caregivers document if patients' today's health is much (+2) or somewhat better today (+1), about the same (±0) today, or somewhat (−1) or much (−2) worse today compared to the day before. Also, a repeated administration of the EQ-5D-5L will also assess the health state fluctuation as a self- and proxy-rating at baseline (before starting the diary), seven days after starting the diary, and on the last day of the diary (day 14). The change in the EQ-5D-5L utilities, EQ-5D-5L level scores and level sum scores (LLS), and EQ-VAS scores from day 1 to day 7 and day 7 to day 14 can be used to assess the variability and reliability of each measure.ii. To assign health state fluctuations to specific health dimensions, we will use the health dimension of the diary and the assessment of EQ-5D-5L dimensions at baseline, seven, and 14 days. The caregiver will be instructed to document in the diary which dimensions could be assigned to the fluctuation of today's health state compared to the day before. We will use dimensions of the EQ-5D-5L and two other patient-reported outcomes measures (PROMs), the EQ Health and Wellbeing instrument (EQ-HWB) (iii. Caregivers will also be asked to document any health events that could have caused the health state fluctuations.iv. To evaluate the consideration of past health state fluctuations in the assessment of today's health, the EQ-5D-5L will be administered on day 14. Subsequently, the caregivers will be interviewed and asked whether or not recurrent health state fluctuations (if applicable) were considered in the assessment of health today using the EQ-5D-5L administered minutes before starting the interview. Furthermore, the caregiver will be asked to state what recall period would be more appropriate to assess HRQoL in people living with dementia more accurately.

PMC10064342

Data management

Data management will be conducted according to the guidelines and recommendations for ensuring Good Epidemiological Practice (GEP) (

PMC10064342

Statistical analyses

PMC10064342

Quantitative data preparation and analyses

EVENTS

Patient and caregiver characteristics will be demonstrated descriptively. Descriptive statistics will also describe health state fluctuations' occurrence, frequency, and intensity. The occurrence will be operationalized dichotomously: no fluctuations reported vs. at least one fluctuation reported. The frequency will be quantified as the number of fluctuations within 14 days. The intensity will be operationalized as follows: much worse or better = ±2; somewhat worse or better = ±1; about the same = ±0) of the reported health events. We will demonstrate the intensity of the health state fluctuations as a mean change per day with standard deviation.Furthermore, we will use exploratory data analysis of the EQ-5D-5L data by reporting the number and percentage of patients reporting each level on each dimension of the EQ-5D-5L using simple descriptive statistics (To assess the association between occurrence, frequency and intensity of the reported health fluctuation and (i) the differences between the baseline, 7-day and 14-days follow-up EQ-5D-5L profile, health utility and EQ-VAS as well as the (ii) reporting of consideration of these health state fluctuations in the assessment of health today in the EQ-5D-5L, we will use appropriate statistics such as cross tables with ANOVA,

PMC10064342

Qualitative data preparation and analysis

dementia

EVENTS

The qualitative interviews will be transcribed, coded using NVivo (version 12, Germany) and analyzed thematically (Results of the thematic analysis of the semi-structured interviews will be compared with the results of the diaries and the EQ-5D-5L assessment to demonstrate how often and intensively health fluctuates in our sample of 50 patients with dementia, what dimensions were affected by these fluctuations, whether documented past events and health fluctuations were considered in the assessment of health today using the EQ-5D-5L, and what recall period would be more appropriate from the perspective of the caregivers to assess health status in such fluctuating conditions.

PMC10064342

Discussion

dementia

EVENTS, DISEASES

To the best of our knowledge, this will be the first study evaluating the health state fluctuations in dementia diseases using a daily diary to document the change in today's health compared to the day before over 14 days. This study may reveal important insights into the frequency and intensity of health state fluctuations in dementia, the affected dimensions and underlying health events. Analogous to the findings of Sun et al. (The information generated from this mixed-methods study can also be vital to inform future research to test modified recall periods of the EQ-5D-5L in PlwD or other fluctuating cyclical health state conditions. The results of this study could make a highly relevant first contribution to more accurate measurements and, thus, give a better understanding of the HRQoL of PlwD. A better understanding of the influences of health state fluctuations on the EQ-5D-5L will make generic PROMs in cyclical health conditions more reliable and generalizable. It will propose a hypothesis on better recall and testing periods for the EQ-5D-5L and other PROMS. Furthermore, the additional information on the presence of fluctuations, the influence of the one-day capture of the EQ-5D-5L and potential changes in this measure necessary to better integrate such information may help to increase the treatment and counseling of patients and their caregivers.

PMC10064342

Limitations

dementia

DISEASE, DISEASES, RECRUITMENT

Due to the COVID-19 situation in Germany, it has to be noticed that recruitment took place under challenging and changing conditions. Especially aged adults are affected by the COVID-19 diseases and the imposed measures to protect against the spread of the disease (Additionally, there are significant differences in the perception of health status between the caregiver and the patient (self and proxy). Findings reported by the caregiver might pronounce the caregiver's perspective on health state fluctuations in PlwD (Finally, the scope of this study will be limited to the federal state of Mecklenburg-Vorpommern. However, previous studies in dementia care research in this state have shown that findings are generalizable to other results nationwide.

PMC10064342

Trial status

RECRUITMENT

Protocol Version 08-30-2022: Recruitment for the pilot phase began on the 15

PMC10064342

Ethics statement

The studies involving human participants were reviewed and approved by University Medicine Greifswald (Registry numbers BB128/21 and BB128/21a). The patients/participants provided their written informed consent to participate in this study.

PMC10064342

Author contributions

NW

NEURODEGENERATIVE DISEASES

The trial was conceptualized by BM, FX, LE, and TK. BM has contributed substantially to the concept of the study and to the draft of the study protocol and will supervise the quantitative analyses. NW is responsible for study processes and trial coordination. LE will be responsible for the qualitative analyses. NW and BM have drafted the manuscript. All authors provided input to, reviewed the manuscript, and approved the final manuscript.The authors acknowledge significant support from Study Nurses and Researchers of the Research Group Translational Health Care Research of the German Center for Neurodegenerative Diseases.

PMC10064342

Abbreviations

PROM, Dementia

NEURODEGENERATIVE DISEASES

ADL, Activities of daily living; DZNE, German center for neurodegenerative diseases; eCRF, electronic case report file; EQ-5D-5L, EuroQoL group's five dimensions five levels questionnaire; EQ VAS, EuroQoL's visual analog scale; GEP, Good Epidemiological Practice; HRQoL, Health-related Quality of Life; ICMJE, International Committee of Medical Journal Editors; MMSE, Mini-Mental State Exam; PlwD; People living with Dementia; PROM, patient-reported outcome measure.

PMC10064342

Conflict of interest

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

PMC10064342

Publisher's note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

PMC10064342

Author disclaimer

The authors' views do not necessarily reflect the views of the EuroQol group. The EuroQol Foundation is not involved in the study's design, data assessment, analyses, or interpretation of the results.

PMC10064342

References

PMC10064342

Key Points

PMC10290249

Question

BREAST CANCER

Does nurse navigation alleviate symptoms in patients with psychological vulnerability and breast cancer?

PMC10290249

Findings

reductions in distress

BREAST CANCER

In this randomized clinical trial of 309 females with breast cancer, nurse navigation did not demonstrate significant reductions in distress.

PMC10290249

Meaning

breast cancer, reductions in distress

BREAST CANCER

Findings of this trial did not show significant reductions in distress among patients with breast cancer with the nurse navigation intervention. Further research is warranted to develop the nurse navigation framework and explore its potential use in clinical practice.

PMC10290249

Importance

breast cancer

BREAST CANCER

The unmet needs regarding symptom management of psychological distress among patients with breast cancer must be addressed. However, little evidence exists on effective interventions, such as nurse navigation.

PMC10290249

Objective

breast cancer

BREAST CANCER, BREAST CANCER

To compare the long-term effects of the REBECCA (Rehabilitation After Breast Cancer) nurse navigation intervention vs usual care in patients with breast cancer who were psychologically vulnerable.

PMC10290249

Design, Setting, and Participants

psychological distress, breast cancer

BREAST CANCER

This parallel randomized clinical trial recruited and evaluated for eligibility adult female patients with newly diagnosed breast cancer and symptoms of psychological distress (distress score of ≥7 points on Distress Thermometer) at Rigshospitalet in Copenhagen, Denmark, from August 2017 to October 2019. This study continued the work of a pilot study, extending the follow-up to 18 months. Patients who met the inclusion criteria were randomized to either standard care or the REBECCA intervention. Intention-to-treat analyses were performed from June 2021 to October 2022.

PMC10290249

Interventions

Patients who were randomized to the REBECCA intervention received nurse navigation and symptom screening as well as standard care. Standard care included regular treatment, nurse support at chemotherapy and radiotherapy appointments, and municipality-based rehabilitation.

PMC10290249

Main Outcomes and Measures

depression, anxiety, pain

SECONDARY, RECURRENCE, BREAST CANCER

The primary outcome was distress, as measured using the Distress Thermometer. The secondary outcomes included symptoms of anxiety, symptoms of depression, breast cancer–specific health-related quality of life, fear of recurrence, sleep, cognitive function, patient activation, pain, health behavior, body mass index, and need for support. Long-term effects at 6, 12, and 18 months were examined using mixed-effect models, adjusting for randomization strata of age and treatment modality.

PMC10290249

Results

−0.09, depression, anxiety

BREAST CANCER

A total of 309 female patients were included in the analysis, with 153 patients randomized to the standard care group and 156 patients randomized to the REBECCA intervention group. Mean (SD) age was 56 (11) years with only small between-group differences. Patients receiving the REBECCA intervention compared with standard care had reduced (although not significant) symptoms of distress, especially at the 12-month follow-up (estimated effect = −0.51 [95% CI, −1.05 to 0.04]; effect size [ES] = −0.49). Significant effects were seen for symptoms of depression at 6 months (estimated effect = −1.39 [95% CI, −2.33 to −0.44]; ES = −0.27), and breast cancer–specific health-related quality of life at 12 months (estimated effect = 4.03 [95% CI, 1.28- 6.77]; ES = 0.31). Nonsignificant reductions were seen for symptoms of anxiety at 6 months (estimated effect = −1.00 [95% CI, −1.95 to −0.06]; ES = −0.21) and 12 months (estimated effect = −1.01 [95% CI, −1.97 to −0.04]; ES = −0.21), and a nonsignificant increase was seen for patient activation at 18 months (estimated effect = 3.52 [95% CI, −0.09 to 7.12]; ES = 0.25). Stronger intervention effects were observed for younger age, low patient activation, less education, and low social support.

PMC10290249

Conclusions and Relevance

breast cancer

BREAST CANCER

Results of this study indicate that patients with breast cancer who were psychologically vulnerable (ie, having moderate to high psychological distress) did not experience significant reduction in distress with nurse navigation. Further research is needed to develop the intervention’s framework and investigate its potential use in clinical practice.

PMC10290249

Trial Registration

ClinicalTrials.gov Identifier:

PMC10290249

Introduction

cancer, breast cancer

CANCER, BREAST CANCER, BREAST CANCER

With the growing cancer survivor population,Nurse navigationThe REBECCA (Rehabilitation After Breast Cancer) intervention was developed to target both psychological and physical symptoms through patient-centered and collaborative care, combining for the first time, to our knowledge, nurse navigation and systematic symptom screening in patients with breast cancer who were psychologically vulnerable, defined as having moderate to high psychological distress.

PMC10290249

Methods

PMC10290249

Study Design and Participants

primary breast cancer, breast cancer

BREAST, BREAST CANCER

The study design was a parallel RCT, and the participants were females with breast cancer who were psychologically vulnerable. The trial protocol (Between August 2017 and October 2019, all patients at the Department of Breast Surgery in Rigshospitalet in Copenhagen, Denmark, were recruited and evaluated for eligibility by 3 trained project nurses (H.D. and B.M.). The inclusion criteria were new (prior to treatment) diagnosis of primary breast cancer; breast cancer surgery; aged 18 years or older; Danish speaking; physically able to attend rehabilitation; able to provide written informed consent; and moderate to high psychological distress, with a score of 7 or higher on the well-validated instrument Distress Thermometer (“Please circle the number [0-10] that best describes how much distress you have been experiencing in the last week including today”), as established previously in Danish patients with breast cancer.Patients were involved in the development of the REBECCA intervention through a previous longitudinal study on symptoms and need for support during breast cancer treatment

PMC10290249

Randomization

Enrolled patients were randomized 1:1 by the 3 project nurses using computer-generated assignment and were stratified according to age (<60 or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy). Patients were randomized to either the standard care or the REBECCA intervention plus standard care (

PMC10290249

Participant Flow Diagram

At baseline, 156 patients in the intervention group and 153 in the standard care group were analyzed.

PMC10290249

Procedures

REBECCA is a manualized intervention with 2 componentsThe REBECCA intervention was delivered by 3 experienced nurses (all of whom had ≥20 years’ experience with different patient groups) who were trained in the manualized sessions through a 3-day program. Patients in both intervention and standard care groups had access to usual care, which included regular treatment and nurse support at chemotherapy and radiotherapy appointments as well as municipality-based rehabilitation, including patient support groups and physical training.

PMC10290249

Outcomes

SENTINEL NODE

Questionnaire data were collected between August 2017 and March 2021 either electronically or on paper (based on patient preference) at baseline and at 6, 12, and 18 months after diagnosis. The primary outcome was psychological distress, as measured using the Distress ThermometerBaseline data were collected on demographic characteristics (age: <60 or ≥60 yearsFrom medical records, we obtained information on breast surgery (lumpectomy, mastectomy, or mastectomy with primary reconstruction), axillary surgery (axillary dissection or sentinel node biopsy), adjuvant radiotherapy (no or yes), adjuvant endocrine therapy (no or yes), chemotherapy (adjuvant, neoadjuvant, or none), and trastuzumab (no or yes). Additionally, nurse registrations on intervention exposure (3 single items) and patient-reported acceptability (7 single items) were obtained in the intervention group.

PMC10290249

Power Considerations

depression, anxiety

SECONDARY

An a priori sample size evaluation was established based on results regarding distress (primary outcome) as well as symptoms of depression and anxiety (secondary outcomes) from the pilot RCT, in which up to 30% between-group difference was observed in change from case to noncase in distress, anxiety, and depression.

PMC10290249

Statistical Analyses

depression, anxiety

SECONDARY, RECURRENCE, BREAST CANCER

Deviations from the original analysis plan were made and finalized prior to data analyses and are described here. Descriptive analyses were applied to examine the differences between study groups at baseline. In intention-to-treat analyses, we applied linear mixed-regression models to examine the effect of the intervention on the primary outcome (distress) and secondary continuous outcomes (symptoms of anxiety and depression, breast cancer–specific HRQOL, fear of recurrence [no baseline data were included, and thus different effects of the intervention were allowed at all time points], sleep, cognitive function, and patient activation) in repeated-measures analyses, with a random effect for patients at 4 time points: baseline and 6-, 12-, and 18-month follow-up. The models assumed no difference between groups at baseline and were in the revised analysis plan, adjusted for randomization strata of age (<60 or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy).Statistical significance was interpreted at 2-sided In the revised analysis plan, we added exploratory analyses to examine whether the intervention effects were modified by age, years of education, social support, patient activation, and chemotherapy, using an interaction term between treatment group and the specific effect modifier. We conducted sensitivity analyses to examine the potential effect of missing data. The last-observation-carried-forward method in the revised analysis plan was replaced by multiple imputations using fully conditional specification methodsIntervention exposure and acceptability were assessed descriptively. Analyses were performed using R, version 4.0.4 (R Core Team)

PMC10290249

Results

A total of 1535 patients were evaluated for eligibility, of which 1222 were excluded (514 were not eligible, 408 declined, and 300 were not distressed). After exclusions, 313 patients were randomized to either the intervention (n = 157) or standard care (n = 156) group (

PMC10290249

Baseline Characteristics of Randomized Patients by Study Group

One person had missing data on years of education.Not employed included women with less education, unemployed status, other government support than age-related pension, and missing information.

PMC10290249

Primary and Secondary Outcomes at Follow-up

Abbreviations: HRQOL, health-related quality of life; NA, not applicable.Assuming no difference between groups at baseline, the model was adjusted for randomization strata of age (<60 or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy).Higher score indicating higher symptoms.Higher score indicating better quality of life.No baseline level to take into account.Cohen

PMC10290249

Intervention Effects

lower distress

Patients in the intervention group reported lower distress, although not significantly lower, at the 6-, 12-, and 18-month follow-up, with the largest reductions observed at 12 months (estimated effect = −0.51 [95% CI, −1.05 to 0.04]; effect size [ES] = −0.49) (

PMC10290249

Forest Plot of Standardized Intervention Effects at 6-, 12-, and 18-Month Follow-up in 309 Patients With Breast Cancer

Standardized outcome scores were applied using fitted models by subtracting the sample mean score from each score and dividing by the SD. Models were adjusted for randomization strata of age (<60 years or ≥60 years) and treatment modality (none, adjuvant chemotherapy, or neoadjuvant chemotherapy). HRQOL indicates health-related quality of life.

PMC10290249

Subgroup Effects, Exposure, and Acceptability

Stronger intervention effects were seen for vulnerable subgroups, such as patients 60 years or older, patients with less education, patients with low patient activation, and patients with low social support, with different strengths for the individual outcomes (eFigures 2 to 9 in

PMC10290249

Intervention Delivery Among 156 Patients

PMC10290249

Discussion

depression, anxiety

BREAST CANCER

Nurse navigation and systematic screening for symptoms provided in the REBECCA intervention showed promise in reducing several psychological symptoms and increasing quality of life. Reduced, but not significant, intervention effects were observed for the primary outcome of distress, and significant effects were observed for symptoms of depression and breast cancer–specific HRQOL. Additionally, nonsignificant effects were found for symptoms of anxiety and patient activation. The intervention effects did not meet the established MIDs, and small to moderate effect sizes were observed (ES = 0.21-0.31). In the pilot RCT (n = 50), significant improvements in distress were found after 12 months. That the effect on distress was not significant has no obvious explanation, but a possible reason is that the effect was especially pronounced in patients with few resources, as we found significant effects at all follow-up periods for patients with fewer than 12 years of education and for patients with low patient activation.

PMC10290249

Nurse Navigation

cancer, fatigue, breast cancer

CANCER, BREAST CANCER

Previous nurse navigation intervention studies rarely demonstrated substantial symptom reduction, such as studies on patients with breast cancer or mixed cancer (including breast) that found no significant effects of nurse navigation on distress, fatigue, quality of life, and health care use (n = 251)The main strength of this RCT is that, to our knowledge, it was the first to test the effect of a manualized nurse navigation program on female patients with high distress levels at diagnosis, thus minimizing a floor effect, and it was also the first to examine long-term effects over 18 months. Previous nurse navigation interventions were only superficially described and covered a variety of techniques, including addressing needs,The REBECCA intervention may work through several pathways: systematic screening for patient-reported outcome symptoms may enhance the detection and professional management of the symptoms.

PMC10290249

Limitations

This study has limitations. With 120 patients per group included at the 18-month follow-up (

PMC10290249

Conclusions

reduced distress, depression, anxiety, breast cancer

BREAST CANCER

We believe the REBECCA intervention fills an important gap in the existing literature regarding providing patient-centered care to patients with breast cancer and social and psychological vulnerabilities. In this RCT, we observed reduced distress in patients who received the REBECCA intervention, especially after 12 months, although the effect was not significant. The intervention resulted in significant improvement in symptoms of depression and breast cancer–specific HRQOL, especially at the 6- and 12-month follow-up, and nonsignificant improvement in symptoms of anxiety and patient activation. The effect sizes were small, but effects were especially pronounced in subgroups with social vulnerabilities, and patient satisfaction was high. To our knowledge, this is the first trial to show the feasibility (through a simple triage approach) of systematically selecting patients with breast cancer who had psychological symptoms of distress and to offer them more comprehensive supportive care, with the nurse navigator actively supporting the patient in accessing health care services that are available within the health care system. These findings warrant further research to develop the nurse navigation framework and to explore the potential translation of this intervention into clinical practice.

PMC10290249

1. Introduction

PsA, PsA., fatigue, Psoriasis, muscle damage, arthritis, psoriasis, musculoskeletal pain, pain, PsO, Fatigue

PSORIASIS, ARTHRITIS, PSORIASIS, SECONDARY, INFLAMMATORY SKIN DISEASE

Fatigue and musculoskeletal pain are also frequent in patients with psoriasis (PsO) without arthritis (PsA). The current study aimed to assess the impact of an intervention program based on aerobic training to reduce fatigue and musculoskeletal pain in patients with PsO without PsA. A total of 118 male patients with PsO volunteered in the current interventional study and were randomly allocated to the experimental (Psoriasis (PsO) is a chronic, immune-mediated inflammatory skin disease with a high prevalence in Western societies [However, musculoskeletal symptoms, including pain and fatigue, are highly prevalent in patients with PsO, having a negative impact on their physical function and quality of life [For the reasons already mentioned, PsO may cause great physical, emotional, and social burdens that inevitably lead to considerable use of medical care and economic resources in both private and public health services [In a more detailed way, increasing physical activity has been inversely associated with the risk of psoriasis, as the most physically active quintile of participants during a 1,195,703 person-years of follow-up (14 years, 1991–2005) had a lower multivariate relative risk (RR) of PsO (0.72 (95% CI, 0.59–0.89; Additionally, high levels of physical activity have been shown to reduce the risk of PsA in patients with PsO in a recent population-based study in Norway [In spite of the above-mentioned pieces of evidence, several studies have demonstrated that patients with PsO generally exhibited more sedentary behavior and were less physically active than matched healthy controls [Finally, this study aimed to assess the influence of an intervention program based on aerobic training on reducing fatigue and musculoskeletal pain in adult patients with psoriasis without PsA. The secondary objective was to determine the effects of the intervention on body composition, maximal aerobic power, and serum muscle damage markers.

PMC10648681

2. Materials and Methods

PMC10648681

2.1. Study Design and Participants

psoriasis

PSORIASIS

A total of 118 patients with psoriasis volunteered for the current interventional study which used a pre-/post-test design. The adequacy of sample size was tested using the statistical software Granmo v7.12 (IMIM, Barcelona, Spain) with an accepted two-sided alpha risk of 0.05 and a beta risk of 0.2. In addition, a loss-to-follow-up rate of 10% was estimated. All participants met the following inclusion criteria: male; 18–45 years of age; a diagnosis of mild psoriasis on the basis of the PASI (psoriasis area severity index) and DLQI (dermatology life quality index) scores < 7 [After reviewing the inclusion/exclusion criteria and signing the informed consent form, the participants were randomly allocated (in a 1:1 ratio) to the experimental (

PMC10648681

2.2. Intervention

Participants in the intervention group participated in a 16-week aerobic training program on a conventional motorized treadmill, for three sessions per week, consisting of a warm-up (10–15 min), 35–50 min treadmill exercise (increasing 5 min each four weeks) at a work intensity of 50–65% of peak heart rate (increasing by 5% every four weeks) measured during a previous maximal treadmill test, and cooling-down (5–10 min). In order to ensure that the training workload was appropriate during the entire session, all participants from the intervention group wore a wireless wearable heart rate monitor (Sport Tester PE3000, Polar Electro, Kempele, Finland).

PMC10648681

2.3. Outcomes

PMC10648681

2.3.1. Patient-Reported Outcomes

PMC10648681

Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue)

fatigue, psoriasis

PSORIASIS

The FACIT-Fatigue scale is a valid and reliable instrument for measuring fatigue, which has also been validated in patients with psoriasis [

PMC10648681

Health Assessment Questionnaire-Disability Index (HAQ-DI)

PsA

This index consists of 20 items, ordered into eight domains to investigate the limitations in performing daily physical activities. The highest item score within each category is used as the score for that category. Finally, the scores for the categories are averaged to construct a single total score ranging from 0 (no disability) to 3 (completely disabled). This scale has been widely used in patients with PsA, both in the literature and in clinical settings [

PMC10648681

Visual Analog Scale (VAS)

psoriatic arthritis, Pain, pain

PSORIATIC ARTHRITIS

Pain intensity was measured using a visual analog scale (VAS). Patients were asked to rate the pain they experienced during the last week on a 100 mm line anchored by two descriptors: 0 meaning “no pain” and 100 meaning “unbearable pain”. A change of >10 mm in the VAS score mm has been considered a clinically important difference in previous studies that focused on patients with psoriatic arthritis [

PMC10648681

2.3.2. Biochemical Outcomes

muscle damage

BLOOD

Blood samples were collected from the antecubital vein into tubes containing EDTA after a 12 h fast. The samples were centrifuged at 3000 rpm for 20 min in a clinical centrifuge. Plasma was separated and stored at −80 °C until further analysis. The levels of plasma glucose and lipid profile (high-density lipoprotein-cholesterol (HDL-cholesterol); low-density lipoprotein-cholesterol (LDL-cholesterol); triglycerides) were measured by spectrophotometry (Advia 2400, Siemens HealthCare Diagnostics, Deerfield, IL,USA). Serum samples were also analyzed using one-step sandwich immunoassays for creatine kinase activity and myoglobin concentration (AU5800 Plus Biochemical Autoanalyzer, Beckman Coulter Inc., Brea, CA, USA) as markers of muscle damage. These outcomes were assessed in each participant at baseline (week 0) and 24 h after the final training session scheduled in the last week (week 16) of the program.

PMC10648681

2.3.3. Aerobic Exercise Power

BRUCE

All participants underwent a modified Bruce multistage maximal treadmill protocol [

PMC10648681

2.3.4. Body Composition

Body composition was assessed using a bioelectrical impedance analysis (BIA; Tanita TBF521) after an overnight fast. The participants were requested not to perform any moderate or vigorous exercise for 24 h before testing and to abstain from eating or drinking for 2 h before testing. They were also asked to urinate immediately before the collection of the samples. Measurements were obtained while the participant was standing erect and barefoot on the analyzer’s footpads and wearing either a swimsuit or undergarments. Total body water (TBW) was estimated using the equation provided by the manufacturer. The instrument was calibrated before each evaluation using known resistors. Fat mass was determined using the equation devised by Sun et al. [

PMC10648681

2.3.5. Nutritional Intake Record

To control for the potential confounding effect of diet, participants were carefully instructed to complete a food consumption frequency questionnaire for three days (two weekdays and one weekend day). Energy and nutrient intakes were calculated using specific software (VD-FEN 2.1, Madrid, Spain) based on updated Spanish food composition tables [No significant difference was found between the intervention and control groups when assessing energy intake (2361 ± 241 vs. 2196 ± 212 kcal;

PMC10648681

2.4. Ethics and Statistics

The study protocol complied with the principles of the Declaration of Helsinki (2013). Written informed consent was obtained from all participants. The current protocol was approved by the Institutional Ethics Committee of Cadiz (Cadiz, Spain). The results are expressed as mean (SD). The Shapiro–Wilk test was used to assess whether the data were normally distributed. To compare the mean values, one-way analysis of variance (ANOVA) with post hoc Bonferroni correction was used to account for multiple tests. For all tests, statistical significance was set at an alpha level of 0.05.

PMC10648681

3. Results

sport-related injuries, psoriatic

Firstly, the baseline characteristics of psoriatic patients in the intervention and control groups are listed in No dropouts or sport-related injuries were reported during the study period. Additionally, the overall mean adherence rate was excellent (92%).When compared to baseline, the experimental group significantly improved their maximal aerobic power (VOThe serum lipid profile was significantly improved after the completion of the intervention program (47.0 ± 7.1 vs. 54.3 ± 6.8 mg/dl HDL-cholesterol; With regard to the patient-reported outcomes, the mean FACIT-fatigue score was significantly increased after completing the intervention program (39.2 ± 9.4 vs. 44.5 ± 8.6;

PMC10648681