Virtual Physical Rehabilitation for Patients Living with Long COVID
1 other identifier
interventional
132
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Aug 2022
Typical duration for not_applicable covid19
2 active sites
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
March 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedStudy Start
First participant enrolled
August 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2024
CompletedNovember 27, 2024
November 1, 2024
1.1 years
March 24, 2022
November 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)
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.
Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary Outcomes (10)
Change in lower-body strength
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 fatigue
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.
Change in health-related quality of life
Baseline, Week 8 (up to 1 week), and at 6 months.
- +5 more secondary outcomes
Study Arms (2)
Virtual home-based rehabilitation plus usual outpatient care
EXPERIMENTALAn 8-week home-based virtual rehabilitation program consisting of exercises and education plus usual care.
Usual outpatient care
NO INTERVENTIONThe control group will receive usual outpatient care which consists of any medical outpatient follow-up visits. The participants will receive a set of written generic instructions on how to manage symptoms and engage in physical activity after critical illness.
Interventions
14 supervised exercise virtual sessions with Kinesiologist and 10 independent exercise sessions. Each session lasts 40 minutes. The exercises consist of aerobic training; functional lower and upper body strengthening; balance; and flexibility exercises. During the first 10 minutes of the first session of each week, there is an educational session. Week 1-2: three supervised virtual sessions Week 3-4: two supervised virtual sessions and one independent session. Week 5-8: one supervised virtual session and two independent sessions.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centrelead
- Canadian Institutes of Health Research (CIHR)collaborator
- RESPIPLUScollaborator
- Santé WillKin (WillKin Health)collaborator
- Canadian Thoracic Societycollaborator
Study Sites (2)
McMaster University
Hamilton, Ontario, L8S 4K1, Canada
Research Institute, McGill University Health Centre
Montreal, Quebec, H4A 3S5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tania Janaudis-Ferreira, PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
- PRINCIPAL INVESTIGATOR
Marla Beauchamp, PDF
McMaster University
- PRINCIPAL INVESTIGATOR
Jean Bourbeau, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientist, Translational Research in Respiratory Diseases Program
Study Record Dates
First Submitted
March 24, 2022
First Posted
March 28, 2022
Study Start
August 1, 2022
Primary Completion
September 22, 2023
Study Completion
March 28, 2024
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available within 12 months from the last visit of the last participant.
- Access Criteria
- Access to anonymized IPD can be requested by researchers.
Summary results will be available on the trial registry site within 12 months from the last visit of the last participant. Other data will be shared on request.