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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 a...
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 ...
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 ...
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 u...
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 basi...
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 ...
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 perform...
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 compa...
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
PMC9864789
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 in...
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 e...
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 tim...
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 f...
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 wit...
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 administrati...
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 Health...
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 HR...
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 bett...
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 ...
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 E...
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 Questi...
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) ...
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...
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, (...
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...
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...
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 fluctua...
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...
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 ...
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, Internatio...
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 ...
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 con...
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...
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 standa...
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 pote...
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 symp...
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...
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 pl...
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 acces...
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 demograp...
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 interven...
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....
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 healt...
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 observe...
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 ...
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 mo...
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 Ps...
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 los...
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 ...
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...
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...
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-ch...
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 imm...
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 Spani...
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 a...
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 ...
PMC10648681