COVIDEx: The COVIDEx intervention was developed by triangulating patient preferences/needs, clinicians' expertise, and best current evidence specific to Long COVID and adapted from interventions for other complex fatigue disorders, which are consistent with evidence informed practice. The program is delivered by trained instructors and comprises of two 50-minute sessions each week for eight weeks. The intervention is designed to be delivered virtually in groups of 6 patients, to eliminate travel requirements for the study. The components of the program are: (i) warm-up (1 min), (ii) cardio training (5 min), (iii) rest (3 min), (iv) balance training (5 min), (v) breathing exercises (3 min), (vi) cognitive training (5 min), (vii) strengthening training (5 min), and (viii) stretching (10min). The COVIDEx program will be paced in order to prevent post-exertional malaise (PEM) in participants.
Study 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 evaluate a new rehabilitation program called COVIDEx for treating fatigue after COVID-19, and compare its effectiveness to the standard treatment currently used. The experimental treatment group will receive an 8-week multi-modal rehabilitation program with two 50-minute sessions per week. 60 participants will be recruited, randomly assigned to the COVIDEx program or standard of care (SoC) and followed for 24 weeks.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Recruitment — Baseline The number of screened patients who are eligible, the proportion of eligible patients who consent, number of patients enrolled per month, reasons for non-enrolment.
Intervention Fidelity — Week 24 The proportion of participants who meet the acceptable level of intervention fidelity (\>80%). A fidelity checklist will be used to assess feasibility that includes adherence (i.e., delivery of each key component of the intervention-absent/present), dosage (amount of intervention delivered, number of sessions completed, overall duration of sessions), quality of intervention delivery (i.e., mode of delivery of COVIDEx), and participant acceptability (extent to which participants in the intervention group found the intervention useful).
Retention — Week 24 The proportion of missed assessments and incomplete outcome measures data, and proportion of participants who withdraw from the trial.
Zelen Design Acceptability — Week 24 The proportion of patients in the standard of care group who provide consent to include their data in the RCT following the disclosure interview.
Trial sites (1)
Facility
City
Region
Status
Parkwood Hospital - St. Joseph's Health Care London
London
Ontario
Recruiting
More Lawson Research Institute of St. Joseph's trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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