Clinical trial NCT04661189: The Cognitive and spOrt Virtual EPIC Training Study for Cardiovascular Diseases
Official title: The Cognitive and spOrt Virtual EPIC Training Study: Investigating the Effects of Home-based Exercise and Cognitive Training in Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: cardiovascular diseases
home-based exercise training
cognitive training
COVID-19
rehabilitation
cognition
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 122
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in general cognitive functioning
timeFrame: Baseline and post-intervention at 6 months
measure: Change in executive functions
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in processing speed
timeFrame: Baseline and post-intervention at 6 months
measure: Change in episodic memory
timeFrame: Baseline and post-intervention at 6 months
Secondary outcomes:
measure: Change in Walking speed
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Functional mobility
timeFrame: Baseline and post-intervention at 6 months
measure: Change in Balance performance
timeFrame: Baseline and post-intervention at 6 months
measure: Change in Lower limb muscles strength
timeFrame: Baseline and post-intervention at 6 months
measure: Change in Cardiorespiratory fitness
timeFrame: Baseline and post-intervention at 6 months
Other outcomes:
measure: Change in Quality-of-life
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Depressive symptomatology
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Anxiety
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Perceived stress
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Repetitive negative thinking
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Self-perceived resilience
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Perceived social support
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Social and community activities involvement
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Self-reported physical activity
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Sleep quality
timeFrame: Baseline and post-intervention at 6 months.
measure: Change in Risk of sleep apnea
timeFrame: Baseline and post-intervention at 6 months.
measure: Dietary patterns
timeFrame: Baseline
measure: Intolerance of Uncertainty
timeFrame: Baseline
measure: Anxiety Sensitivity
timeFrame: Baseline
measure: Perceived vulnerability to disease
timeFrame: Baseline
measure: Cognitive Reserve
timeFrame: Baseline
measure: Self-reported masculinity and femininity traits
timeFrame: Baseline
Locations:
city: Montréal
country: Canada
facility: Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
state: Quebec
Study officials:
References:
citation: 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.