NCT04392115

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
28 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 15, 2020

Last Update Submit

May 15, 2020

Conditions

Comorbidities and Coexisting ConditionsSocial Isolation

Keywords

COVID-19Virtual careOlder adultsExerciseSocial Isolation

Outcome Measures

Primary Outcomes (1)

  • Patient-reported disability 90 days after enrollment

    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used . It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society. Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.

    Assessing change in score from baseline data collection to 90 days from enrollment

Secondary Outcomes (10)

  • Mental Health

    Assessing change in the participants GAD-7 score from baseline to monthly scores for 12 months.

  • Function

    Monthly step count from enrollment to monthly step counts for 12 months from enrollment.

  • Health-related quality of life

    Assessing change in the participants EQ-5D-5L score from baseline to monthly scores for 12 months.

  • Frailty

    Assessing change in the participants CFS score from baseline to monthly scores for 12 months.

  • All-cause mortality.

    From enrollment to 12 months after enrollment.

  • +5 more secondary outcomes

Study Arms (2)

Exercise Group

EXPERIMENTAL

The home-based exercise program called the PREPARE program. 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.

Behavioral: The PREPARE program

Control Group

NO INTERVENTION

The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.

Interventions

The PREPARE programBEHAVIORAL

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.

Exercise Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • years of age or older
  • or more co-morbidities
  • recent discharge from hospital

You may not qualify if:

  • Inability to communicate in English or in French
  • Unreachable by telephone
  • Unstable cardiovascular or valvular disease
  • Discharged to Long-Term Care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Social IsolationCOVID-19Motor Activity

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Daniel I McIsaac, MD

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivy Salter

CONTACT

613-798-5555isalter@ohri.ca

Emily Hladkowicz

CONTACT

613-292-6714emhladkowicz@toh.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2020

First Posted

May 18, 2020

Study Start

June 15, 2020

Primary Completion

December 15, 2020

Study Completion

September 15, 2021

Last Updated

May 18, 2020

Record last verified: 2020-05