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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| RESPIPLUS | UNKNOWN |
| Santé WillKin (WillKin Health) | UNKNOWN |
| Canadian Thoracic Society |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual home-based rehabilitation plus usual outpatient care | Experimental | An 8-week home-based virtual rehabilitation program consisting of exercises and education plus usual care. |
|
| Usual outpatient care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group: Virtual home-based rehabilitation plus usual outpatient care | Other | 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. |
| 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. |
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8S 4K1 | Canada | ||
| Research Institute, McGill University Health Centre |
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.
Data will be available within 12 months from the last visit of the last participant.
Access to anonymized IPD can be requested by researchers.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| UNKNOWN |
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|
| 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. |
| Montreal |
| Quebec |
| H4A 3S5 |
| Canada |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |