Virtual Physical Rehabilitation for Patients Living with Long COVID

McGill University Health Centre/Research Institute of the McGill University Health Centre2 sites in 1 country132 target enrollmentAugust 1, 2022

ConditionsCOVID-19 Post COVID-19 Long COVID

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Enrollment: 132
Locations: 2
Primary Endpoint: Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate whether a timely, virtual home-based physical rehabilitation program for patients living with long COVID can improve functional mobility compared to usual care.

Registry

clinicaltrials.gov

Start Date

August 1, 2022

End Date

March 28, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Responsible Party

Principal Investigator

Tania Janaudis-Ferreira

Scientist, Translational Research in Respiratory Diseases Program

McGill University Health Centre/Research Institute of the McGill University Health Centre

Eligibility Criteria

Inclusion Criteria

•(i) adult patients (18+ years old) who have had a confirmed or probable COVID-19 infection and who have self-reported persisting symptoms of either reduced mobility, muscle weakness, dyspnea, or fatigue;
•(ii) participants must be technologically capable of connecting (either independently or through household members) with an online videoconferencing platform through an e-mail invitation; and
•(iii) be able to collaborate with the research assistant to complete the virtual assessment sessions or have a family member available to help.

Exclusion Criteria

•(i) pre-existing or newly identified severe cognitive impairment;
•(ii) inability to speak or comprehend English or French;
•(iii) known or self-reported acute and/or uncontrolled cardiac, musculoskeletal, or neurological condition that might render rehabilitation participation unsafe.

Outcomes

Primary Outcomes

Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)

Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.

The AM-PAC is a validated, self-reported instrument assessing activity limitations based on the International Classification of Functioning, Disability, and Health (ICF). Each item is scored from 1 (unable to perform) to 4 (none or no difficulty) with lower scores indicating lower levels of function.

Secondary Outcomes

Change in lower-body strength(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in anxiety and depression(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in health state utilities(Baseline, Week 8 (up to 1 week), and at 6 months.)
Self-reported health service use(30 days after the 8-week period.)
Change in cognitive function(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in the degree of distress in response to trauma(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in fatigue(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in health-related quality of life(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in functional mobility(Baseline, Week 8 (up to 1 week), and at 6 months.)
Change in dyspnea(Baseline, Week 8 (up to 1 week), and at 6 months.)