The Cognitive and spOrt Virtual EPIC Training Study for Cardiovascular Diseases (COVEPICARDIO)

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Behavioral: Physical exercise training; Behavioral: Cognitive training

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 Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Florent Besnier, PhD; Phone Number: 4333 514-374-1480; Email: florent.besnier@umontreal.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T1N6
      • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multidomain intervention; The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month.	Behavioral: Physical exercise training; 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.; Behavioral: Cognitive training; 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.
Experimental: Physical exercise intervention; The physical exercises intervention will include the remote monitoring of physical exercise training for 6-month.	Behavioral: Physical exercise training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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

Other Outcome Measures

Outcome Measure	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	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 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 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.
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 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.
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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 10, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: rehabilitation; cognition; COVID-19; cardiovascular diseases; cognitive training; home-based exercise training
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: ICM 2020-2785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No