COVID-19NCT05298878
Virtual Physical Rehabilitation for Patients Living with Long COVID
A study testing Intervention Group: Virtual home-based rehabilitation plus usual outpatient care in people with COVID-19 and Post COVID-19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Post COVID-19, Long COVID
- What is being tested?
- Intervention Group: Virtual home-based rehabilitation plus usual outpatient care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2022to 28 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- participants must be technologically capable of connecting (either independently or through household members) with an online videoconferencing platform through an e-mail invitation; and
- be able to collaborate with the research assistant to complete the virtual assessment sessions or have a family member available to help.
Who cannot join
- pre-existing or newly identified severe cognitive impairment;
- inability to speak or comprehend English or French;
- known or self-reported acute and/or uncontrolled cardiac, musculoskeletal, or neurological condition that might render rehabilitation participation unsafe.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McMaster University
Hamilton, Ontario, L8S 4K1
Research Institute, McGill University Health Centre
Montreal, Quebec, H4A 3S5
About this study
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.
- Conditions
- COVID-19, Post COVID-19, Long COVID
- Being tested
- Intervention Group: Virtual home-based rehabilitation plus usual outpatient care
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Group: Virtual home-based rehabilitation plus usual outpatient careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention Group: Virtual home-based rehabilitation plus usual outpatient 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary outcomes (10)
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.
Measured: 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.
Measured: Baseline, Week 8 (up to 1 week), and at 6 months.
Change in fatigue
Measured by the Fatigue Visual Analog Scale.
Measured: Baseline, Week 8 (up to 1 week), and at 6 months.
Change in dyspnea
Measured by the Transition Dyspnea Index.
Measured: 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).
Measured: 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).
Measured: Baseline, Week 8 (up to 1 week), and at 6 months.
Change in anxiety and depression
Measured by the Hospital Anxiety and Depression Scale.
Measured: Baseline, Week 8 (up to 1 week), and at 6 months.
Change in cognitive function
Measured by the AM-PAC Cognition Subscale.
Measured: 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.
Measured: 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.
Measured: 30 days after the 8-week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Aug 2022
- Primary completion22 Sep 2023
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), RESPIPLUS, Santé WillKin (WillKin Health), Canadian Thoracic Society
- Responsible party
- Principal investigator, Tania Janaudis-Ferreira, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Tania Janaudis-Ferreira, PhD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreMarla Beauchamp, PDF, Principal investigator, McMaster UniversityJean Bourbeau, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298878
- Sponsor's protocol ID
- 2022-8559
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2022
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Physical Rehabilitation for Patients Living with Long COVID
- ClinicalTrials.gov ID
- NCT05298878
- Acronym / sponsor ID
- 2022-8559
- Conditions
- COVID-19, Post COVID-19, Long COVID
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), RESPIPLUS, Santé WillKin (WillKin Health), Canadian Thoracic Society
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual home-based rehabilitation plus usual outpatient care | Experimental | Other: Intervention Group: Virtual home-based rehabilitation plus usual outpatient careAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
- participants must be technologically capable of connecting (either independently or through household members) with an online videoconferencing platform through an e-mail invitation; and
- be able to collaborate with the research assistant to complete the virtual assessment sessions or have a family member available to help.
Key exclusion criteria (3 listed)
- pre-existing or newly identified severe cognitive impairment;
- inability to speak or comprehend English or French;
- known or self-reported acute and/or uncontrolled cardiac, musculoskeletal, or neurological condition that might render rehabilitation participation unsafe.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Group: Virtual home-based rehabilitation plus usual outpatient care14 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. | Other | Virtual home-based rehabilitation plus usual outpatient care |
Primary outcome
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.
10 secondary outcomes
Change in lower-body strength
Time frame: 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.
Change in fatigue
Time frame: 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.
Change in health-related quality of life
Time frame: 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.
Change in anxiety and depression
Time frame: 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.
Change in the degree of distress in response to trauma
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Janaudis-Ferreira, PhD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Marla Beauchamp, PDF principal investigator
McMaster University
Jean Bourbeau, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group: Virtual home-based rehabilitation plus usual outpatient care in people with COVID-19 and Post COVID-19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.