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

Fatigue Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

Long COVID or post-COVID-19 syndrome is a complex syndrome that affects people following SARS-CoV-2 infection. This currently affects 1.4 million Canadians, with the most common symptom being fatigue. This feasibility trial will compare a newly developed rehabilitation program (COVIDEx) for treating post-COVID-19 fatigue to standard of care. The experimental treatment group will receive an 8-week multi-modal rehabilitation program with two 50-minute sessions per week. Sixty participants will be recruited and randomly assigned to the COVIDEx program or standard of care and will be followed for 24 weeks.

Clinical Trial Description

The investigators propose a Zelen randomized, single-centre trial with two parallel groups (intervention vs standard of care). Zelen designs are recommended for evaluating real-world intervention effectiveness under conditions of incomplete adherence, thus are ideally suited to test rehabilitation interventions for PC19S. Participants will be identified and recruited from St. Joseph's Post-Acute COVID-19 outpatient program at Parkwood Institute. Once the clinician and research personnel have determined eligibility, they will log into the web-based computer-generated randomization system. The randomization scheme will be constructed using varying, permuted blocks, stratified by sex and hospitalized status (1 = hospitalized, 0 = otherwise). As this is a Zelen trial, participants will be randomized prior to obtaining consent. Participants randomized to COVIDEx will be told they are part of an RCT comparing COVIDEx to standard of care (SoC) and that they were randomized to the COVIDEx group. They will be asked to participate and sign consent. The treatment period will be 8 weeks, with 2 COVIDEx sessions per week.

Participants randomized to the SoC group will be asked to consent to participate in an observational study to follow the natural history of PC19S and costs associated with SoC for post-COVID-19 treatments. By blinding SoC patients to the presence of the experimental group, the Zelen design will mitigate the effects of feeling disappointed, frustrated, or discouraged about being assigned SoC, which is important given the primary outcome is a subjective, patient reported outcome measure (detection bias). This approach will also reduce the likelihood that patients in the SoC group begin self-motivated programs trying to mimic the intervention (performance bias) since there is no standard of care for this population. Upon completion of the study, the control group will attend a disclosure interview where the randomized nature of the study will be revealed, the rationale for this deception/treatment delay will be provided and full informed consent to use their data for the RCT will be sought. SoC patients will then be offered the COVIDEx intervention. The study team will not gather data from control group participants if they choose to participate in the COVIDEx intervention.

Outcomes will be collected at baseline, 4-, 8-, 12- and 24- weeks follow-up during assessment sessions. Qualitative focus groups will explore the acceptability of the intervention and barriers/facilitators to intervention adherence and study retention. Only participants randomized to the COVIDEx group will be asked to participate in focus groups. ;

Related Conditions & MeSH terms

• COVID-19
• Fatigue
• Post-COVID-19 Syndrome
• Syndrome

• NCT number: NCT06156176
• Study type: Interventional
• Source: Lawson Health Research Institute
• Contact: Arden Lawson, BMSc
• Phone: 519-646-6100
• Email: arden.lawson@sjhc.london.on.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Completion date: December 2025