COVID-19, Long COVID, Post COVID-19
Conditions
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.
Interventions
OTHERIntervention 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.
Sponsors
Canadian Institutes of Health Research (CIHR)
RESPIPLUS
Santé WillKin (WillKin Health)
Canadian Thoracic Society
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in functional mobility | 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. |
| Change in fatigue | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the Fatigue Visual Analog Scale. |
| Change in dyspnea | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the Transition Dyspnea Index. |
| Change in health-related quality of life | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the Short Form 12-item Health Survey (SF-12). |
| Change in lower-body strength | 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. |
| Change in anxiety and depression | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the Hospital Anxiety and Depression Scale. |
| Change in cognitive function | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the AM-PAC Cognition Subscale. |
| Change in the degree of distress in response to trauma | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the Impact of Event Scale - Revised. |
| Self-reported health service use | 30 days after the 8-week period. | Doctors visits, emergency department visits and hospital readmission etc. |
| Change in health state utilities | Baseline, Week 8 (up to 1 week), and at 6 months. | Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L). |
Countries
Canada
Outcome results
None listed