Rehabilitation Interventions for Physical Capacity and Quality of Life in Adults With Post-COVID-19 Condition: A Systematic Review and Meta-Analysis.
Dimitra V Pouliopoulou, Joy C Macdermid, Emily Saunders...
https://pubmed.ncbi.nlm.nih.gov/37725376Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06156176
Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial
Led by Lawson Research Institute of St. Joseph's · Updated on 2025-08-01
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
L
Lawson Research Institute of St. Joseph's
Lead Sponsor
W
Western University, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Long COVID affects about 1.4 million Canadians who have had a SARS-CoV-2 infection, with fatigue being the most common symptom. Researchers are evaluating a new rehabilitation program called COVIDEx to treat fatigue after COVID-19 and compare it to the standard care currently used. This randomized feasibility trial uses a modified Zelen design to study rehabilitation under real-world conditions, focusing on effectiveness and patient-reported outcomes for individuals living with Long COVID. Participants are randomly assigned to either the COVIDEx group or standard care. The COVIDEx group takes part in an 8-week program with two 50-minute virtual group sessions weekly, including warm-up, cardio, balance training, breathing exercises, cognitive training, strengthening, and stretching, all paced to prevent post-exertional malaise (PEM). The standard care group receives no intervention during this period but is offered COVIDEx after study completion. The study includes blood oxygen and heart rate monitoring using Apple Watches, and participants use an app to report symptoms at random times up to 24 weeks. Participants will be assessed at baseline and at 4, 8, 12, and 24 weeks for various outcomes such as fatigue, physical exertion, brain function, and quality of life. The study collects both quantitative and qualitative data, including one-on-one interviews with COVIDEx participants to explore program acceptability and adherence. The total follow-up period is 24 weeks, and safety monitoring includes tracking symptom flare-ups and metabolic responses during exercise sessions.
CONDITIONS
Brief Title
Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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 or clinical diagnosis)
- Fatigue symptoms starting within 3 months of COVID-19 infection and lasting at least 2 months
- Fatigue symptoms not explained by another diagnosis
- Fatigue may be new onset or persistent from initial illness
- Fatigue may fluctuate or relapse over time
- Able to walk 10-15 minutes and recover within 30-60 minutes without significant post-exertional malaise
- Has technology to access Microsoft Teams and Webex (computer, laptop, or tablet)
You will not qualify if you...
- Active SARS-CoV-2 infection
- Pre-existing physical, cognitive, or mental health conditions making exercise unsafe or consent unattainable (e.g., major neurocognitive disorder, schizophrenia, chronic fatigue syndrome)
- Unable to follow study procedures
- Pregnant or breastfeeding
- Received investigational agents in another study within 30 days before screening
- Has metal implants in head or heart (pins, plates, pacemakers)
- Currently participating in other studies related to COVID-19, exercise, or fatigue interventions, or participated within 30 days before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual) to determine eligibility
Treatment
Duration - 8 weeks
Participants randomized to the COVIDEx group will participate in two 50-minute virtual rehabilitation sessions per week for 8 weeks. The program includes warm-up, cardio training, rest, balance training, breathing exercises, cognitive training, strengthening training, and stretching, paced to prevent post-exertional malaise. Participants randomized to the standard of care group will not receive an intervention during this period.
Twice-weekly virtual sessions for 8 weeks
Follow-up
Duration - Up to 24 weeks
Participants will attend assessment sessions at baseline, 4, 8, 12, and 24 weeks to collect clinical outcomes and feasibility measures. Participants will be asked to wear an Apple Watch to monitor health data during the 24-week study period and complete ecological momentary assessments via a mobile app to report symptoms after sessions. Control group participants will also complete these assessments.
Assessment sessions at baseline, 4, 8, 12, and 24 weeks plus ongoing monitoring via wearable device and app
Trial Site Locations
Total: 1 location
1
Parkwood Hospital - St. Joseph's Health Care London
London, Ontario, Canada, N6C 0A7
Actively Recruiting
Loading map...
Research Team
N
Nicole Billias, BPH, CPT
A
Arden Lawson, BMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Prevalence of post-acute sequelae of SARS-CoV-2 infection in people living with HIV: a systematic review with meta-analysis.
Dimitra V Pouliopoulou, Nicole Billias, Joy C MacDermid...
https://pubmed.ncbi.nlm.nih.gov/39802304Prevalence and Impact of Postexertional Malaise on Recovery in Adults With Post-COVID-19 Condition: A Systematic Review With Meta-analysis.
Dimitra V Pouliopoulou, Myranda Hawthorne, Joy C MacDermid...
https://pubmed.ncbi.nlm.nih.gov/39921187Rehabilitation interventions and outcomes for post-COVID condition: a scoping review.
Emily G Saunders, Dimitra V Pouliopoulou, Erin Miller...
https://pubmed.ncbi.nlm.nih.gov/40017924Pursuing Reduction in Fatigue After COVID-19 via Exercise and Rehabilitation (PREFACER): a protocol for a randomised feasibility trial.
Nicole Billias, Dimitra V Pouliopoulou, Arden Lawson...
https://pubmed.ncbi.nlm.nih.gov/41213692