Clinical Trials Logo

Clinical Trial Summary

This is a randomized trial of home-based exercises versus control for older adults during the COVID-19 pandemic. The hypothesis is that participation in a home-based program will reduce the risk of adverse effects of physical distancing by decreasing patient-reported disability, improving mental health and avoiding hospitalization or institutionalization for vulnerable older people


Clinical Trial Description

Background:More than 6.5 million Canadians are > 65 years of age. Over half of older Canadians live with multiple comorbidities, leaving them at high risk of adverse outcomes of COVID-19. Social isolation and physical distancing orders are especially important to protect the health of this high-risk population. Vulnerable older Canadians are also at high risk of physical and mental health deterioration caused by the physical distancing meant to protect them from COVID-19. Effective management of the COVID-19 pandemic and its consequences will require evidence-based strategies to support isolated vulnerable older Canadians. Exercise interventions can reduce the adverse health effects of social isolation and demonstrate larger effect sizes in older people with comorbidities. However, no exercise interventions have been tested in an acute isolation scenario such as the COVID-19 pandemic, which also requires that exercise interventions be home-based and remotely supported, presenting unique challenges to participation and adherence.

Our team is uniquely positioned re-orient proven and robust programming, supported by a national network of investigators and existing infrastructure. We can immediately launch a large-scale trial to test the effectiveness of a remotely supported home exercise program (designed in partnership with vulnerable older Canadians) to mitigate the negative consequences of physical distancing to keep older Canadians healthy and safe from COVID-19. We hypothesize that participation in the PREPARE program will decrease the individual, health system and population health impacts of COVID19 induced physical distancing and social isolation.

Research aims:Estimate the effectiveness of a remotely supported, home-based multimodal exercise program for older people with multiple comorbidities to improve our primary outcome: patient-reported disability 90-days after enrollment; secondary outcomes: patient-centered (depression, anxiety, quality of life, frailty, survival, 1-year disability scores, COVID19 severity) and system-relevant (admissions, emergency visits, institutionalization, costs, cost-effectiveness).

Methods: Design, setting and participants: Parallel-arm multicenter randomized controlled trial at 3 Canadian hospitals. People >65 years old recently discharged home with >2 comorbidities will be included. Intervention: Three month supported home-based exercise program with demonstrated efficacy, feasibility and acceptability for vulnerable older people.

Outcomes and sample size: We will have 90% power to detect a clinically important difference of in our primary outcome (validated WHODAS tool, 90-days post-enrollment) with 372 participants (186/arm) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04392115
Study type Interventional
Source Ottawa Hospital Research Institute
Contact Ivy Salter
Phone 613-798-5555
Email isalter@ohri.ca
Status Not yet recruiting
Phase N/A
Start date June 15, 2020
Completion date September 15, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05831475 - LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation N/A
Completed NCT03291717 - Bridging Community Gaps Photovoice N/A
Recruiting NCT06175299 - Social Functions to Promote Home-based Cognitive Training N/A
Completed NCT04573972 - Using Social Connectedness to Increase Physical Activity N/A
Not yet recruiting NCT05031247 - Refugee Mental Health and Wellness Pilot Study N/A
Completed NCT02596672 - Promoting Walking in Older Adults Living in Independent Living Communities in Northern Ireland: A Feasibility Study. N/A
Active, not recruiting NCT05678985 - Evaluating Impact and Implementation of Choose to Move (Phase 4) N/A
Active, not recruiting NCT04072185 - PHYSICAL ACTIVITY AS A MEASURE OF IMPROVING THE EMOTIONAL STATE AND SOCIALIZATION IN THE ELDERLY N/A
Completed NCT06018974 - Digital Gaming Intervention for Older People in Long-term Care N/A
Recruiting NCT04897802 - Identification and Clinical Relevance of an Oxytocin Deficient State (GLP1 Study) Phase 4
Recruiting NCT06138301 - Telepsychiatry for Social Isolation in Youths N/A
Enrolling by invitation NCT06434298 - Provincial Scale-up of Choose to Move (CTM) Phase 4 N/A
Recruiting NCT05520450 - Telematic Support Group in Patients With Feelings of Loneliness and Social Isolation
Recruiting NCT05019053 - Acceptability/Feasibility of COVID-19 Intervention N/A
Completed NCT04567940 - ENRED@TE. Social Support in Southern Spain. Interventional Study N/A
Completed NCT04281654 - Effects of Arts Engagement on Physical Performance, Cognition, Social Isolation, and Self-Perception in Older Adults N/A
Completed NCT03472729 - AGE-ON 2.0: Expanding and Evaluating a Tablet Training Program for Older Adults N/A
Completed NCT03293823 - HARP-Project 1 Cognitive Training N/A
Completed NCT02835989 - Community Paramedicine at Home N/A
Completed NCT02041585 - Discharge Functional Status and Rehospitalization in the Elderly