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Completed

NCT Number: NCT04661189

The Cognitive and spOrt Virtual EPIC Training Study for 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.

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Key information

Conditions

Cardiovascular Diseases COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Montreal, Quebec, H1T1N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in general cognitive functioning

    Time frame: Baseline and post-intervention at 6 months

    Validated remote version of Montreal Cognitive Assessment

  2. 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).

  3. 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).

  4. 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).

Secondary outcomes

  1. Change in Walking speed

    Time frame: Baseline and post-intervention at 6 months.

    4-meter walking test (m/s).

  2. Change in Functional mobility

    Time frame: Baseline and post-intervention at 6 months

    Timed up and Go test (s).

  3. Change in Balance performance

    Time frame: Baseline and post-intervention at 6 months

    Timed one-leg standing test (s)

  4. Change in Lower limb muscles strength

    Time frame: Baseline and post-intervention at 6 months

    Timed Sit-to-Stand test (s).

  5. Change in Cardiorespiratory fitness

    Time frame: Baseline and post-intervention at 6 months

    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)

Other outcomes

  1. Change in Quality-of-life

    Time frame: Baseline and post-intervention at 6 months.

    36-Item Short Form Health Survey (Scale ranges from 0-100, with a higher score indicating a better health status).

  2. Change in Depressive symptomatology

    Time frame: Baseline and post-intervention at 6 months.

    Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).

  3. Change in Anxiety

    Time frame: Baseline and post-intervention at 6 months.

    State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety)

  4. Change in Perceived stress

    Time frame: Baseline and post-intervention at 6 months.

    Perceived Stress Scale questionnaire (Score ranges from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe)

  5. Change in Repetitive negative thinking

    Time frame: Baseline and post-intervention at 6 months.

    Perseverative thinking questionnaire (Score ranges from 0-60, with a higher score indicating more repetitive negative thinking)

  6. Change in Self-perceived resilience

    Time frame: Baseline and post-intervention at 6 months.

    Connor-Davidson Resilience Scale 10 questionnaire (Score ranges from 0-40, with a higher indicating better the resilience)

  7. Change in Perceived social support

    Time frame: Baseline and post-intervention at 6 months.

    Lubben Social Network Scale questionnaire (Score ranges from 0-30, with a higher score indicating more social engagement).

  8. Change in Social and community activities involvement

    Time frame: Baseline and post-intervention at 6 months.

    Social and community involvement questionnaire (Score ranges from 0-200, with a higher score indicating more social and community involvement).

  9. Change in Self-reported physical activity

    Time frame: Baseline and post-intervention at 6 months.

    Physical Activity Scale for the Elderly questionnaire (Score ranges from 0-400, with a higher score indicating better level of physical activity).

  10. Change in Sleep quality

    Time frame: Baseline and post-intervention at 6 months.

    Pittsburg Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality)

  11. Change in Risk of sleep apnea

    Time frame: Baseline and post-intervention at 6 months.

    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).

  12. Dietary patterns

    Time frame: Baseline

    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).

  13. Intolerance of Uncertainty

    Time frame: Baseline

    Intolerance of Uncertainty scale questionnaire (Score ranges from 27-135, with a higher score indicating higher intolerance of uncertainty).

  14. Anxiety Sensitivity

    Time frame: Baseline

    Anxiety Sensitivity Index questionnaire (Score ranges from 0-64, with a higher score indicating a higher sensitivity to anxiety)

  15. Perceived vulnerability to disease

    Time frame: Baseline

    Perceived vulnerability to disease questionnaire (Score ranges from 15-95, with a higher score indicating a higher perceived vulnerability to disease).

  16. Cognitive Reserve

    Time frame: Baseline

    Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve).

  17. Self-reported masculinity and femininity traits

    Time frame: Baseline

    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).

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

The Cognitive and spOrt Virtual EPIC Training Study: Investigating the Effects of Home-based Exercise and Cognitive Training in Cardiovascular Diseases

Acronym: COVEPICARDIO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Nov 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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