Clinical trial NCT05298878: Virtual Physical Rehabilitation for Patients Living with Long COVID
Official title: Virtual Physical Rehabilitation for Patients Living with Long COVID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Post COVID-19
Long COVID
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: RESPIPLUS
name: Santé WillKin (WillKin Health)
name: Canadian Thoracic Society
First posted: 2022-03-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in the basic mobility domain of the Activity Measure for Post-Acute Care (AM-PAC)
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
Secondary outcomes:
measure: Change in lower-body strength
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in functional mobility
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in fatigue
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in dyspnea
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in health-related quality of life
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in health state utilities
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in anxiety and depression
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in cognitive function
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Change in the degree of distress in response to trauma
timeFrame: Baseline, Week 8 (up to 1 week), and at 6 months.
measure: Self-reported health service use
timeFrame: 30 days after the 8-week period.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Montreal
country: Canada
facility: Research Institute, McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Tania Janaudis-Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Marla Beauchamp, PDF
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Jean Bourbeau, MD
role: PRINCIPAL_INVESTIGATOR
References: