Virtual Physical Rehabilitation for Patients Living With Long COVID

Study 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.

Official Title
-----------------
Virtual Physical Rehabilitation for Patients Living With Long COVID

Conditions
-----------------
COVID-19, Post COVID-19, Long COVID

Intervention / Treatment
-----------------
* Other: Intervention Group: Virtual home-based rehabilitation plus usual outpatient care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual home-based rehabilitation plus usual outpatient care<br>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<br>* 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.<br>|
| No Intervention: Usual outpatient care<br>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. |