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

NCT06156176 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-01

No results posted yet for this 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.

Conditions

  • Long-COVID
  • Long COVID-19
  • Post-COVID-19 Syndrome
  • Post-COVID Syndrome
  • Fatigue
  • Post COVID-19 Condition
  • Post-COVID Condition

Interventions

OTHER

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.

Sponsors & Collaborators

  • Western University, Canada

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Pavlos Bobos, PhD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2026-04-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156176 on ClinicalTrials.gov