Back to resultsVirtual Physical Rehabilitation for Patients Living With Long COVID
Primary Purpose
COVID-19, Post COVID-19, Long COVID
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intervention Group: Virtual home-based rehabilitation plus usual outpatient care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
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.
Sites / Locations
- McMaster University
- Research Institute, McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Virtual home-based rehabilitation plus usual outpatient care
Usual outpatient care
Arm Description
An 8-week home-based virtual rehabilitation program consisting of exercises and education plus usual 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Change in fatigue
Measured by the Fatigue Visual Analog Scale.
Change in dyspnea
Measured by the Transition Dyspnea Index.
Change in health-related quality of life
Measured by the Short Form 12-item Health Survey (SF-12).
Change in health state utilities
Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L).
Change in anxiety and depression
Measured by the Hospital Anxiety and Depression Scale.
Change in cognitive function
Measured by the AM-PAC Cognition Subscale.
Change in the degree of distress in response to trauma
Measured by the Impact of Event Scale - Revised.
Self-reported health service use
Doctors visits, emergency department visits and hospital readmission etc.
Full Information
NCT ID
NCT05298878
First Posted
March 24, 2022
Last Updated
August 25, 2023
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
1. Study Identification
Unique Protocol Identification Number
NCT05298878
Brief Title
Virtual Physical Rehabilitation for Patients Living With Long COVID
Official Title
Virtual Physical Rehabilitation for Patients Living With Long COVID
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Post COVID-19, Long COVID
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual home-based rehabilitation plus usual outpatient care
Arm Type
Experimental
Arm Description
An 8-week home-based virtual rehabilitation program consisting of exercises and education plus usual care.
Arm Title
Usual outpatient care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intervention Group: Virtual home-based rehabilitation plus usual outpatient care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)
Description
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.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary Outcome Measure Information:
Title
Change in lower-body strength
Description
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.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in functional mobility
Description
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.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in fatigue
Description
Measured by the Fatigue Visual Analog Scale.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in dyspnea
Description
Measured by the Transition Dyspnea Index.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in health-related quality of life
Description
Measured by the Short Form 12-item Health Survey (SF-12).
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in health state utilities
Description
Measured by the EuroQol 5-dimension 5-level Questionnaire (EQ-5D-5L).
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in anxiety and depression
Description
Measured by the Hospital Anxiety and Depression Scale.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in cognitive function
Description
Measured by the AM-PAC Cognition Subscale.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Change in the degree of distress in response to trauma
Description
Measured by the Impact of Event Scale - Revised.
Time Frame
Baseline, Week 8 (up to 1 week), and at 6 months.
Title
Self-reported health service use
Description
Doctors visits, emergency department visits and hospital readmission etc.
Time Frame
30 days after the 8-week period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania Janaudis-Ferreira, PhD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marla Beauchamp, PDF
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Bourbeau, MD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Research Institute, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3S5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Virtual Physical Rehabilitation for Patients Living With Long COVID
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