Virtual Physical Rehabilitation for Patients Living With Long COVID

COVID-19 Clinical Trial

Official title:

Virtual Physical Rehabilitation for Patients Living With Long COVID

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05298878
• Other study ID #: 2022-8559
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: March 2024

Study information

• Verified date: August 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Long COVID
• Post COVID-19

Intervention

Other:
• Intervention 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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario
Canada	Research Institute, McGill University Health Centre	Montreal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR), Canadian Thoracic Society, RESPIPLUS, Santé WillKin (WillKin Health)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Change in fatigue	Measured by the Fatigue Visual Analog Scale.	Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary	Change in dyspnea	Measured by the Transition Dyspnea Index.	Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary	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.
Secondary	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.
Secondary	Change in anxiety and depression	Measured by the Hospital Anxiety and Depression Scale.	Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary	Change in cognitive function	Measured by the AM-PAC Cognition Subscale.	Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary	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.
Secondary	Self-reported health service use	Doctors visits, emergency department visits and hospital readmission etc.	30 days after the 8-week period.