Virtual Physical Rehabilitation for Patients Living With Long COVID

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • McMaster University
    • Quebec
      • Montreal, Quebec, Canada, H4A 3S5
        • Research Institute, McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual home-based rehabilitation plus usual outpatient care
An 8-week home-based virtual rehabilitation program consisting of exercises and education plus usual care.

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.

No Intervention: Usual outpatient care
The 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lower-body strength
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
The 1-minute sit-to-stand test (1-min STS) is feasible to use in hospital survivors of COVID-19. It is used to assess lower body-strength, exercise tolerance, and exertional desaturation. The score is the total number of stands within one minute.
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in functional mobility
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
The fast-Timed-Up-and-Go test (TUG) assesses physical function and functional mobility. The score consists of the time taken to complete the test activity, in seconds.
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in fatigue
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the Fatigue Visual Analog Scale.
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in dyspnea
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the Transition Dyspnea Index.
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in health-related quality of life
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the Short Form 12-item Health Survey (SF-12).
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in health state utilities
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L).
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in anxiety and depression
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the Hospital Anxiety and Depression Scale.
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in cognitive function
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the AM-PAC Cognition Subscale.
Baseline, Week 8 (up to 1 week), and at 6 months.
Change in the degree of distress in response to trauma
Time Frame: Baseline, Week 8 (up to 1 week), and at 6 months.
Measured by the Impact of Event Scale - Revised.
Baseline, Week 8 (up to 1 week), and at 6 months.
Self-reported health service use
Time Frame: 30 days after the 8-week period.
Doctors visits, emergency department visits and hospital readmission etc.
30 days after the 8-week period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Estimated)

September 1, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

March 24, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available within 12 months from the last visit of the last participant.

IPD Sharing Access Criteria

Access to anonymized IPD can be requested by researchers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Intervention Group: Virtual home-based rehabilitation plus usual outpatient care

3
Subscribe