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COVEPICARDIO 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 with cardiovascular diseases.
Cardiac rehabilitation is a class I level A recommendation with clinical benefits that are now well documented. Due to the COVID-19 pandemic, accessibility to rehabilitation services and exercise training programs are limited. Quarantine measures can induce collateral damages to cardiovascular and psychological health, in particular in clinical population. Cardiovascular diseases (CVD) are associated with cognitive deficits and increased risk of dementia later in life. Specifically for CVD, physical inactivity and excessive sedentary lifestyle induced by confinement decrease cardiorespiratory capacity, increase the risk of acute events and rehospitalization. Maintaining a minimum of physical activity during a health crisis is fundamental. In this context, our team has developed an innovative program of exercise and cognitive training at home. Considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors with CVD, this project also addresses the added benefits of a multidomain intervention combining a home-based physical exercise intervention with a cognitive training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidomain intervention | Experimental | The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month. |
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| Physical exercise intervention | Experimental | The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise training | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in general cognitive functioning | Validated remote version of Montreal Cognitive Assessment | Baseline and post-intervention at 6 months |
| Change in executive functions | Validated remote version of Rey auditory verbal learning test, Trail Making Test, as well as Phonological and Semantic Fluency, Similarity, and Digit Span neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 6 months. |
| Change in processing speed | Validated remote version of Rey auditory verbal learning test, Trail Making Test, as well as Phonological and Semantic Fluency, Similarity, and Digit Span neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 6 months |
| Change in episodic memory | Validated remote version of Rey auditory verbal learning test, Trail Making Test, as well as Phonological and Semantic Fluency, Similarity, and Digit Span neuropsychological tests and iPad tests (Composite Z-score). | Baseline and post-intervention at 6 months |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality-of-life | 36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status). | Baseline and post-intervention at 6 months. |
| Change in Depressive symptomatology |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute | Montreal | Quebec | H1T1N6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39899189 | Derived | Besnier F, Dupuy EG, Gagnon C, Vincent T, Vrinceanu T, Blanchette CA, Iglesies-Grau J, Saillant K, Chabot-Blanchet M, Belleville S, Juneau M, Vitali P, Gayda M, Nigam A, Bherer L. Effects of home-based exercise with or without cognitive training on cognition and mobility in cardiac patients: A randomized clinical trial. Geroscience. 2025 Aug;47(4):5651-5667. doi: 10.1007/s11357-025-01530-y. Epub 2025 Feb 3. | |
| 34938780 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000091942 | Cognitive Training |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Cognitive training | Behavioral | 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. |
|
| 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 |
Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).
| Baseline and post-intervention at 6 months. |
| Change in Anxiety | State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety) | Baseline and post-intervention at 6 months. |
| Change in Perceived stress | Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe) | Baseline and post-intervention at 6 months. |
| Change in Repetitive negative thinking | Perseverative thinking questionnaire (Score ranges from 0-60, with a higher score indicating more repetitive negative thinking) | Baseline and post-intervention at 6 months. |
| Change in Self-perceived resilience | Connor-Davidson Resilience Scale 10 questionnaire (Score ranges from 0-40, with a higher indicating better the resilience) | Baseline and post-intervention at 6 months. |
| Change in Perceived social support | Lubben Social Network Scale questionnaire (Score ranges from 0-30, with a higher score indicating more social engagement). | Baseline and post-intervention at 6 months. |
| Change in Social and community activities involvement | Social and community involvement questionnaire (Score ranges from 0-200, with a higher score indicating more social and community involvement). | Baseline and post-intervention at 6 months. |
| Change in Self-reported physical activity | Physical Activity Scale for the Elderly questionnaire (Score ranges from 0-400, with a higher score indicating better level of physical activity). | Baseline and post-intervention at 6 months. |
| Change in Sleep quality | Pittsburg Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality) | Baseline and post-intervention at 6 months. |
| Change in Risk of sleep apnea | Berlin Questionnaire (Participants are classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories.High Risk: if there are 2 or more categories where the score is positive. Low Risk: if there is only 1 or no categories where the score is positive). | Baseline and post-intervention at 6 months. |
| Dietary patterns | Short Diet Questionnaire (Score ranges from 15-45 points, with a score between 15-29 categorised as unhealthy, 30-37 as somewhat unhealthy, and 38 or more as a healthy diet). | Baseline |
| Intolerance of Uncertainty | Intolerance of Uncertainty scale questionnaire (Score ranges from 27-135, with a higher score indicating higher intolerance of uncertainty). | Baseline |
| Anxiety Sensitivity | Anxiety Sensitivity Index questionnaire (Score ranges from 0-64, with a higher score indicating a higher sensitivity to anxiety) | Baseline |
| Perceived vulnerability to disease | Perceived vulnerability to disease questionnaire (Score ranges from 15-95, with a higher score indicating a higher perceived vulnerability to disease). | Baseline |
| Cognitive Reserve | Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve). | Baseline |
| Self-reported masculinity and femininity traits | Short Form Bem Sex-Role Inventory questionnaire (30 items questionnaire with 10 items assessing the femininity traits, 10 items assessing the masculinity traits, and 10 items neutral, not scored. Two scores are calculated for femininity and masculinity, respectively, and range from 10-70, whit a higher score indicating a higher femininity or masculinity trait). | Baseline |
| Derived |
| Besnier F, Dupuy EG, Gagnon C, Vincent T, Gregoire CA, Blanchette CA, Saillant K, Bouabdallaoui N, Grau JI, Berube B, Olmand M, Marin MF, Belleville S, Juneau M, Vitali P, Gayda M, Nigam A, Bherer L. Investigation of the Effects of Home-Based Exercise and Cognitive Training on Cognitive and Physical Functions in Cardiac Patients: The COVEPICARDIO Study Protocol of a Randomized Clinical Trial. Front Cardiovasc Med. 2021 Dec 6;8:740834. doi: 10.3389/fcvm.2021.740834. eCollection 2021. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |