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
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)
Behavioral: The PREPARE program
A home-based exercise program guided by paper materials, weekly phone calls, and a DVD.
Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility.
Inclusion Criteria:
- 65 years of age or older
- 2 or more co-morbidities
- recent discharge from hospital
Exclusion Criteria:
- Inability to communicate in English or in French
- Unreachable by telephone
- Unstable cardiovascular or valvular disease
- Discharged to Long-Term Care
Ivy Salter
613-798-5555 - 13790
isalter@ohri.ca
Emily Hladkowicz
613-292-6714
emhladkowicz@toh.on.ca
Daniel I McIsaac, MD, Principal Investigator
The Ottawa Hospital Research Institute