Cardiovascular DiseasesCOVEPICARDIONCT04661189
The Cognitive and spOrt Virtual EPIC Training Study for Cardiovascular Diseases
A study testing Physical exercise training and Cognitive training in people with Cardiovascular Diseases, run by Montreal Heart Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Physical exercise training and Cognitive training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- 18 May 2020to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 and older
- Have access to internet
- Have access to a tablet (i.e., iPad or Android) or a computer
- Diagnostic of cardiovascular disease (stable chronic systolic or diastolic heart failure, atrial fibrillation, documented atherosclerotic disease).
- Able to do light to moderate aerobic exercice training
- With no contraindication to exercise training
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
Montreal, Quebec, H1T1N6
About this study
Official title: The Cognitive and spOrt Virtual EPIC Training Study: Investigating the Effects of Home-based Exercise and Cognitive Training in Cardiovascular Diseases
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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Physical exercise training, Cognitive training
- Keywords
- cardiovascular diseases, home-based exercise training, cognitive training, COVID-19, rehabilitation, cognition
- Medical subject headings
- Cardiovascular Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise trainingBehavioural
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.
Cognitive trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Multidomain intervention | Experimental | The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month. Receives: Behavioral: Physical exercise training; Behavioral: Cognitive training |
| Physical exercise intervention | Experimental | The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month. Receives: Behavioral: Physical exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general cognitive functioning
Validated remote version of Montreal Cognitive Assessment
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and post-intervention at 6 months
Secondary outcomes (5)
Change in Walking speed
4-meter walking test (m/s).
Measured: Baseline and post-intervention at 6 months.
Change in Functional mobility
Timed up and Go test (s).
Measured: Baseline and post-intervention at 6 months
Change in Balance performance
Timed one-leg standing test (s)
Measured: Baseline and post-intervention at 6 months
Change in Lower limb muscles strength
Timed Sit-to-Stand test (s).
Measured: 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)
Measured: Baseline and post-intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start18 May 2020
- Primary completion1 May 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Bherer, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661189
- Sponsor's protocol ID
- ICM 2020-2785
- Acronym
- COVEPICARDIO
- Status last verified
- Nov 2023
- First submitted
- 3 Dec 2020
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39899189Besnier 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.
PubMed 34938780
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cognitive and spOrt Virtual EPIC Training Study: Investigating the Effects of Home-based Exercise and Cognitive Training in Cardiovascular Diseases
- ClinicalTrials.gov ID
- NCT04661189
- Acronym / sponsor ID
- COVEPICARDIO / ICM 2020-2785
- Conditions
- Cardiovascular Diseases
- Keywords
- cardiovascular diseases, home-based exercise training, cognitive training, COVID-19, rehabilitation, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 18 May 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidomain intervention | Experimental | Behavioral: Physical exercise training, Behavioral: Cognitive trainingThe multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month. |
| Physical exercise intervention | Experimental | Behavioral: Physical exercise trainingThe physical exercises intervention will include the remote monitoring of physical exercise training for 6-month. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 50 and older
- Have access to internet
- Have access to a tablet (i.e., iPad or Android) or a computer
- Diagnostic of cardiovascular disease (stable chronic systolic or diastolic heart failure, atrial fibrillation, documented atherosclerotic disease).
- Able to do light to moderate aerobic exercice training
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise trainingParticipants 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. | Behavioural | Multidomain intervention, Physical exercise intervention |
| Cognitive trainingParticipants 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. | Behavioural | Multidomain intervention |
Primary outcome
Change in general cognitive functioning
Time frame: Baseline and post-intervention at 6 months
Validated remote version of Montreal Cognitive Assessment
Change in executive functions
Time frame: Baseline and post-intervention at 6 months.
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).
Change in processing speed
Time frame: Baseline and post-intervention at 6 months
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).
Change in episodic memory
Time frame: Baseline and post-intervention at 6 months
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).
5 secondary outcomes
Change in Walking speed
Time frame: Baseline and post-intervention at 6 months.
Change in Functional mobility
Time frame: Baseline and post-intervention at 6 months
Change in Balance performance
Time frame: Baseline and post-intervention at 6 months
Change in Lower limb muscles strength
Time frame: Baseline and post-intervention at 6 months
Change in Cardiorespiratory fitness
Time frame: Baseline and post-intervention at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Derived from this study: PubMed 39899189Besnier 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.
- Derived from this study: PubMed 34938780Besnier 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise training and Cognitive training in people with Cardiovascular Diseases, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general cognitive functioning (time frame: Baseline and post-intervention at 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04661189, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2023.