Rehabilitation program to reduce fatigue after COVID-19

Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial

This study is testing a new rehabilitation program called COVIDEx to see if it can help people with Long COVID feel less tired compared to standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT06156176 on ClinicalTrials.gov

What this trial studies

This feasibility trial evaluates a new rehabilitation program called COVIDEx aimed at treating fatigue in individuals suffering from Long COVID. The study will recruit 60 participants who will be randomly assigned to either the COVIDEx program or standard care, with both groups followed for 24 weeks. The intervention consists of an 8-week multi-modal rehabilitation program with two 50-minute sessions per week. The trial employs a modified Zelen design to assess the effectiveness of the intervention under real-world conditions, ensuring comprehensive data collection on health outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with documented fatigue symptoms following a COVID-19 infection.

Not a fit: Patients currently experiencing an active SARS-CoV-2 infection or those with pre-existing conditions that affect physical or cognitive function may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly alleviate fatigue symptoms in patients recovering from COVID-19.

How similar studies have performed: While there have been studies addressing rehabilitation for Long COVID, this specific approach using the COVIDEx program is novel and untested.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

London, Ontario

• Parkwood Hospital - St. Joseph's Health Care London — London, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Pavlos Bobos, PhD — Western University
• Study coordinator: Nicole Billias, BPH, CPT

Conditions: Long-COVID, Long COVID-19, Post-COVID-19 Syndrome, Post-COVID Syndrome, Fatigue, Post COVID-19 Condition, Post-COVID Condition