Clinical trial NCT04635462: The Cognitive and spOrt Virtual EPIC Training Study
Official title: The Cognitive and spOrt Virtual EPIC Training Study: INVESTIGATING THE EFFECTS OF HOME-BASED EXERCISE AND COGNITIVE TRAINING
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Aging
Remote monitoring
Home-based training
Cognitive Training
Physical Exercise
Cognition
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 127
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed COVEPIC 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.

Detailed description: Due to the actual pandemic of COVID-19 around the world, social distancing is recommended, which causes a reduction of social interaction and physical activity. Therefore, this health crisis may have collateral effects on cognitive, physical, and psychological health, especially in elderly people who are more likely to be isolated, and for whom social distancing is of paramount importance. Physical exercise practice has been demonstrated to improve cognitive functioning, along with mobility and physical capacity, and to promote psychological well-being. This is the reason why governmental health authorities, as well as the scientific community recommend to stay physically active, especially in this pandemic period. However, in the current context full-time physical training in sport centres cannot be largely promoted. Effective solutions to help older adults in maintaining regular and efficient physical exercise while maintaining social distancing, are thus needed. Consequently, the current project proposes first to investigate the potential of a remote monitoring of physical activity to promote cognitive, physical and psychological health of older adults. Also, considering the added benefits of combining cognitive training to physical exercise to further enhance health and cognition in seniors, this project also addresses the added benefits of a multidomain intervention combining a physical exercise intervention with a home-based cognitive training.

Eligibility criteria: Inclusion Criteria:

* Adult aged 50 and older
* Have access to internet
* Have access to a tablet (i.e. iPad or Android) or a computer

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
* Diagnostic of cardiovascular disease (e.g., chronic systolic and diastolic heart failure, somatic aortic stenosis, atrial fibrillation, malignant arrhythmias, documented atherosclerotic disease).

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:
affiliation: Montreal Heart Institute
name: Louis Bherer, PhD
role: PRINCIPAL_INVESTIGATOR
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