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

NCT06156176 | Recruiting DMC

• 1 other identifier: PBPREFACER01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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; Post COVID-19 Condition; Post-COVID Condition

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline

• 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).

  Week 24

• Retention

  The proportion of missed assessments and incomplete outcome measures data, and proportion of participants who withdraw from the trial.

  Week 24

• 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.

  Week 24

Secondary Outcomes (14)

• Change in 30-Second Sit-to-Stand Test

  Baseline to Week 24

• Change in Borg Scale of Perceived Physical Exertion

  Baseline to Week 24

• Change in The DePaul Symptom Questionnaire

  Baseline to Week 24

• Change in DePaul Symptom Questionnaire - Post-Exertional Malaise (short-form)

  Baseline to Week 24

• Change in EQ-5D-5L

  Baseline to Week 24

Study Arms (2)

COVIDEx

EXPERIMENTAL

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

Other: COVIDEx

Standard of Care

NO INTERVENTION

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

Interventions

COVIDEx OTHER

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.

COVIDEx

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lawson Research Institute of St. Joseph's: lead
• Western University, Canada: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Parkwood Hospital - St. Joseph's Health Care London

London, Ontario, N6C 0A7, Canada

RECRUITING

Related Publications (5)

• Pouliopoulou DV, Macdermid JC, Saunders E, Peters S, Brunton L, Miller E, Quinn KL, Pereira TV, Bobos P. Rehabilitation Interventions for Physical Capacity and Quality of Life in Adults With Post-COVID-19 Condition: A Systematic Review and Meta-Analysis. JAMA Netw Open. 2023 Sep 5;6(9):e2333838. doi: 10.1001/jamanetworkopen.2023.33838.

  PMID: 37725376 BACKGROUND

• Pouliopoulou DV, Billias N, MacDermid JC, Miller E, O'Brien KK, Quinn KL, Malvankar-Mehta MS, Pereira TV, Cheung AM, Razak F, Stranges S, Bobos P. Prevalence of post-acute sequelae of SARS-CoV-2 infection in people living with HIV: a systematic review with meta-analysis. EClinicalMedicine. 2024 Dec 17;79:102993. doi: 10.1016/j.eclinm.2024.102993. eCollection 2025 Jan.

  PMID: 39802304 BACKGROUND

• Pouliopoulou DV, Hawthorne M, MacDermid JC, Billias N, Miller E, Quinn K, Decary S, Razak FA, Cheung A, Galiatsatos P, Pereira TV, Bobos P. Prevalence and Impact of Postexertional Malaise on Recovery in Adults With Post-COVID-19 Condition: A Systematic Review With Meta-analysis. Arch Phys Med Rehabil. 2025 Aug;106(8):1267-1278. doi: 10.1016/j.apmr.2025.01.471. Epub 2025 Feb 5.

  PMID: 39921187 BACKGROUND

• Saunders EG, Pouliopoulou DV, Miller E, Billias N, MacDermid JC, Brunton L, Pereira TV, Quinn KL, Bobos P. Rehabilitation interventions and outcomes for post-COVID condition: a scoping review. BMJ Public Health. 2025 Feb 26;3(1):e001827. doi: 10.1136/bmjph-2024-001827. eCollection 2025.

  PMID: 40017924 BACKGROUND

• Billias N, Pouliopoulou DV, Lawson A, D'Alessandro V, Bryant DM, Peters S, Rushton AB, Miller E, Brunton L, McGuire S, Nicholson M, Birmingham TB, MacDermid JC, Quinn KL, Razak F, Goulding S, Galiatsatos P, Saunders E, Marsh J, Pereira TV, Bobos P. Pursuing Reduction in Fatigue After COVID-19 via Exercise and Rehabilitation (PREFACER): a protocol for a randomised feasibility trial. BMJ Open. 2025 Nov 9;15(11):e102112. doi: 10.1136/bmjopen-2025-102112.

  PMID: 41213692 DERIVED

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Pavlos Bobos, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Billias, BPH, CPT

CONTACT

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

Arden Lawson, BMSc

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors (physiotherapists) will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two parallel treatment groups: COVIDEx rehabilitation program and standard of care.

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: December 5, 2023
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)