Recruiting

Exercise & Rehabilitation

Sponsor:

Lawson Research Institute of St. Joseph's

Code:

NCT06156176

Conditions

Long-COVID

Long COVID-19

Post-COVID-19 Syndrome

Post-COVID Syndrome

Fatigue

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

COVIDEx

Study Details

Brief 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

Study ID

NCT06156176

Start date

Apr 1, 2025

Status verified date

Apr, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: COVIDEx

This group will receive two 50-minute rehabilitation sessions per week for 8 weeks.

no intervention: Standard of Care

This group will receive standard of care (no intervention) for the 8-week intervention period.

Interventions

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.

Primary outcome measure

  • Recruitment [ Time Frame: Baseline ]
  • Intervention Fidelity [ Time Frame: Week 24 ]
  • Retention [ Time Frame: Week 24 ]
  • Zelen Design Acceptability [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Nicole Billias, BPH, CPT

519-646-6100Nicole.Billias@sjhc.london.on.ca

Arden Lawson, BMSc

519-646-6100Arden.Lawson@sjhc.london.on.ca

Locations

Parkwood Hospital - St. Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

Nicole Billias, BPH, CPT

519-646-6100Nicole.Billias@sjhc.london.on.ca

More Information

Sponsor

Lawson Research Institute of St. Joseph's

Last update posted

Aug 1, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lawson Research Institute of St. Joseph's on 2025-08-01.