Clinical trial NCT04392115: The PREPARE for COVID Trial
Official title: PRomoting Exercise During the Pandemic to Increase Activity and Reduce Effects of Social Isolation for COVID: The PREPARE for COVID Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Comorbidities and Coexisting Conditions
Social Isolation
Keywords: COVID-19
Virtual care
Older adults
Exercise
Social Isolation
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 372
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported disability 90 days after enrollment
timeFrame: Assessing change in score from baseline data collection to 90 days from enrollment
Secondary outcomes:
measure: Mental Health
timeFrame: Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.
measure: Function
timeFrame: Monthly step count from enrollment to monthly step counts for 12 months from enrollment.
measure: Health-related quality of life
timeFrame: Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.
measure: Frailty
timeFrame: Assessing change in the participants CFS score from baseline to monthly scores for 12 months.
measure: All-cause mortality.
timeFrame: From enrollment to 12 months after enrollment.
measure: Health System - Emergency Department Visits
timeFrame: Monthly for 12 months following enrollment.
measure: Health System - Re-admission
timeFrame: Monthly for 12 months following enrollment.
measure: Health System - Transfer to Long-Term Care
timeFrame: Monthly for 12 months following enrollment.
measure: COVID-19 test results
timeFrame: Monthly for 12 months following enrollment.
measure: Safety [Adverse Events]
timeFrame: Assessing frequency of, or change in any safety events from enrollment up to 90 days from enrollment between the exercise group and control group.
Other outcomes:
Locations:
Study officials:
affiliation: The Ottawa Hospital Research Institute
name: Daniel I McIsaac, MD
role: PRINCIPAL_INVESTIGATOR
References: