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

• Status: Active, not recruiting
• Conditions: COVID-19; Long COVID; Post COVID-19
• Intervention / Treatment: Other: Intervention Group: Virtual home-based rehabilitation plus usual outpatient care

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania Janaudis-Ferreira, PhD; Phone Number: 514-619-0871; Email: tania.janaudis-ferreira@mcgill.ca

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	Other: Intervention Group: Virtual home-based rehabilitation plus usual outpatient 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)	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	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	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	Measured by the Fatigue Visual Analog Scale.	Baseline, Week 8 (up to 1 week), and at 6 months.
Change in dyspnea	Measured by the Transition Dyspnea Index.	Baseline, Week 8 (up to 1 week), and at 6 months.
Change in health-related quality of life	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	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	Measured by the Hospital Anxiety and Depression Scale.	Baseline, Week 8 (up to 1 week), and at 6 months.
Change in cognitive function	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	Measured by the Impact of Event Scale - Revised.	Baseline, Week 8 (up to 1 week), and at 6 months.
Self-reported health service use	Doctors visits, emergency department visits and hospital readmission etc.	30 days after the 8-week period.

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); RESPIPLUS; Santé WillKin (WillKin Health); Canadian Thoracic Society
• 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

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

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022-8559

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