The Cognitive and spOrt Virtual EPIC Training Study for Cardiovascular Diseases

NCT04661189 | Completed DMC

• 1 other identifier: ICM 2020-2785
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases

Keywords

cardiovascular diseases; home-based exercise training; cognitive training; COVID-19; rehabilitation; cognition

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in Walking speed

  Baseline and post-intervention at 6 months.

• Change in Functional mobility

  Baseline and post-intervention at 6 months

• Change in Balance performance

  Baseline and post-intervention at 6 months

• Change in Lower limb muscles strength

  Baseline and post-intervention at 6 months

• Change in Cardiorespiratory fitness

  Baseline and post-intervention at 6 months

Other Outcomes (17)

• Change in Quality-of-life

  Baseline and post-intervention at 6 months.

• Change in Depressive symptomatology

  Baseline and post-intervention at 6 months.

• Change in Anxiety

  Baseline and post-intervention at 6 months.

Study Arms (2)

Multidomain intervention

EXPERIMENTAL

The multidomain intervention will combine a remote monitoring of home-based cognitive training with physical exercise training for 6-month.

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.

Behavioral: Physical exercise training

Interventions

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.

Multidomain intervention; Physical exercise intervention

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.

Multidomain intervention

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (1)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T1N6, Canada

Location

Related Publications (2)

• 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.

  PMID: 39899189 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.

  PMID: 34938780 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; COVID-19

Interventions

Exercise; Cognitive Training

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Scientific Director, Direction of Prevention

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: May 18, 2020
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)