Status:
RECRUITING
Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial
Lead Sponsor:
Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
Western University, Canada
Canadian Institutes of Health Research (CIHR)
Conditions:
Long-COVID
Long COVID-19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Long COVID is a complex condition that affects approximately 1.4 million Canadians following SARS-CoV-2 infection. Fatigue is the most common symptom of Long COVID. This feasibility trial will evaluat...
Detailed Description
The investigators propose a modified Zelen, randomized, single-centre, feasibility trial with two parallel groups (intervention vs standard of care). Zelen designs are recommended for evaluating inter...
Eligibility Criteria
Inclusion
- Adults of at least 18 years of age
- Able to provide informed consent
- Can speak and understand English
- Documented history of SARS-CoV-2 infection (positive PCR/antigen test during acute illness or clinical diagnosis by physician during or after the acute illness)
- Fatigue symptoms within 3 months of COVID-19 infection, lasting at least 2 months
- Fatigue symptoms cannot be explained by an alternative diagnosis
- Fatigue symptoms may be new onset following initial recovery from an acute COVID-19 infection or persist from the initial illness
- Fatigue symptoms may have an episodic nature, fluctuate or relapse over time
- Minimal functional capability: able to walk 10-15 minutes and be recovered within 30-60 minutes or without significant post-exertional malaise (PEM)
- Has applicable technology to access Microsoft Teams and Webex (i.e., computer, laptop, tablet)
Exclusion
- Active SARS-CoV-2 infection
- Pre-existing physical, cognitive, and/or mental health conditions that make exercise contraindicated, consent unattainable, or that cause symptoms similar to those seen in post COVID-19 (e.g., major neurocognitive disorder, schizophrenia, chronic fatigue syndrome) that could affect data
- Inability to follow study procedures
- Pregnant and/or breastfeeding
- Received investigational agents as part of a separate study within 30 days of the screening visit
- Has any type of metal bodily implant in head or heart (i.e., pins, plates, pacemakers)
- Current participation in other studies related to COVID-19, exercise, and/or fatigue interventions OR participation within 30 days of the screening visit
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06156176
Start Date
April 1 2025
End Date
April 1 2026
Last Update
August 1 2025
Active Locations (1)
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1
Parkwood Hospital - St. Joseph's Health Care London
London, Ontario, Canada, N6C 0A7