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.
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)
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
Parallel
COVIDEx
Other interventionThe 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.
Recruitment
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
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
The proportion of missed assessments and incomplete outcome measures data, and proportion of participants who withdraw from the trial.
Zelen Design Acceptability
The proportion of patients in the standard of care group who provide consent to include their data in the RCT following the disclosure interview.
Change in 30-Second Sit-to-Stand Test
The 30-Second Sit-to-Stand Test involves repeatedly standing up from and sitting down on a chair within a 30-second time frame, assessing lower body strength and functional fitness in individuals. Participants are timed for 30 seconds and the number of times they stand up and sit down in a chair in the 30-second period is recorded. More repetitions indicate higher functional ability (i.e., endurance, leg strength).
Change in Borg Scale of Perceived Physical Exertion
The Borg Rating of Perceived Exertion (RPE) is a subjective scale used to assess an individual's perceived intensity of physical activity, providing a measure of their effort level during exercise. We are using the 6-20 scale (6 being easy exercise to 20 being extremely vigorous). Participants rate how difficult exercise/activity feels from 6 (no exertion at all) to 20 (maximal exertion).
Change in The DePaul Symptom Questionnaire
The DePaul Symptom Questionnaire (DSQ) is a self-report instrument used to assess the severity and frequency of symptoms related to chronic fatigue syndrome in individuals, covering various domains including fatigue, sleep, and cognitive issues. Participants' physical symptoms are rated on a five-point scale for frequency (0=none of the time, to 4=all of the time) and severity (0=no symptoms, 4=very severe).
Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (short-form)
Post-Exertional Malaise (PEM) will be assessed using the DSQ-PEM-SF. This questionnaire is used to assess the severity and frequency of symptoms related to PEM in individuals, covering various domains including fatigue, sleep, and cognitive issues.
Click on the lead sponsor to view all of their trials.
Lawson Research Institute of St. Joseph's
Lead sponsor
Western University, Canada
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
