The Cognitive and spOrt Virtual EPIC Training Study

Study Overview
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Brief Summary
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The proposed COVEPIC trial is designed to document the effects of remote monitoring of physical exercise and home-based cognitive training on cognitive and physical functions in older adults.

Detailed Description
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Due to the actual pandemic of COVID-19 around the world, social distancing is recommended, which causes a reduction of social interaction and physical activity. Therefore, this health crisis may have collateral effects on cognitive, physical, and psychological health, especially in elderly people who are more likely to be isolated, and for whom social distancing is of paramount importance. Physical exercise practice has been demonstrated to improve cognitive functioning, along with mobility and physical capacity, and to promote psychological well-being. This is the reason why governmental health authorities, as well as the scientific community recommend to stay physically active, especially in this pandemic period. However, in the current context full-time physical training in sport centres cannot be largely promoted. Effective solutions to help older adults in maintaining regular and efficient physical exercise while maintaining social distancing, are thus needed. Consequently, the current project proposes first to investigate the potential of a remote monitoring of physical activity to promote cognitive, physical and psychological health of older adults. Also, considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors, this project also addresses the added benefits of a multidomain intervention combining a physical exercise intervention with a home-based cognitive training.

Official Title
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The Cognitive and spOrt Virtual EPIC Training Study: INVESTIGATING THE EFFECTS OF HOME-BASED EXERCISE AND COGNITIVE TRAINING

Conditions
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Aging

Intervention / Treatment
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* Other: Physical exercise training
* Other: Cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult aged 50 and older Have access to internet Have access to a tablet (i.e. iPad or Android) or a computer Exclusion Criteria: Non-cardiopulmonary limitation to exercise (e.g., arthritis) Severe exercise intolerance Respiratory disease (e.g., asthma, COPD, COVID-19) Mini Mental Scale Examination (MMSE) telephone version lower than 19/23 Diagnostic of cardiovascular disease (e.g., chronic systolic and diastolic heart failure, somatic aortic stenosis, atrial fibrillation, malignant arrhythmias, documented atherosclerotic disease).

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multidomain intervention<br>The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month. | Other: Physical exercise training<br>* Participants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda.<br>Other: Cognitive training<br>* Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed different mnemotechnic, as well as be taught about memory in aging in general. The memory training will be provided by videos capsules. To track adherence to cognitive training, participants will be asked to complete a journal and mark days and times where they took part in the various cognitive training sessions.<br>|
| Experimental: Physical exercise intervention<br>The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month. | Other: Physical exercise training<br>* Participants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in general cognitive functioning | Validated remote version of Montreal Cognitive Assessment (0-28 score, with a higher score indicating a better cognitive functioning). | Baseline and post-intervention at 6 months. | 
| Change in executive functions | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 6 months. | 
| Change in processing speed | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 6 months. | 
| Change in episodic memory | Validated remote version of neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking speed | 4-meter walking test (m/s). | Baseline and post-intervention at 6 months. | 
| Change in Functional mobility | Timed up and Go test (s). | Baseline and post-intervention at 6 months. | 
| Change in Balance performance | Timed one-leg standing test (s). | Baseline and post-intervention at 6 months. | 
| Change in Lower limb muscles strength | Timed Sit-to-Stand test (s). | Baseline and post-intervention at 6 months. | 
| Change in Cardiorespiratory fitness | Matthews cardiorespiratory fitness questionnaire (the score is an estimation of individual VO2 max (ml.kg.min) and range from 15-50, with a higher score indicating a higher VO2max). | Baseline and post-intervention at 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Remote monitoring, Home-based training, Cognitive Training, Physical Exercise, Cognition