Feasibility and Preliminary Efficacy of a Group-based Telerehabilitation Program in People With Post-COVID-19 Sequelae (TEPCO).

Not Applicable

Completed

• Conditions: Long COVID-19 Syndrome; Long COVID; Long COVID Syndrome

• Registration Number: NCT06952127
• Lead Sponsor: Centre intégré universitaire de santé et de services sociaux de la Mauricie-et-du-Centre-du-Québec

Brief Summary

The goal of this study pilot randomized controlled study is to evaluate the feasibility of the study procedures and to compare the preliminary efficacy of a rehabilitation program given in a "remote" (telerehabilitation) or "face-to-face" model for adult patients who had confirmed SARS-CoV-2 infection and still have symptoms after eight weeks of infection. The main question it aims to answer is:

* Are the study procedures feasible?

* Will the two groups have similar results for the preliminary efficacy outcomes?

Researchers will compare group telerehabilitation to a face-to-face group to see if it's comparable.

Participants will:

* Take part in a 60-minute training session, 3 times a week in person or remotely

* Visit the clinic before starting the training program and after 8 weeks of training

* Keep a diary of their symptoms, if any

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-07
• Primary Completion: 2024-03-29
• Study Completion: 2024-03-29
• Status Verified: 2025-04
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• adult patients (≥18 years)
• confirmed SARS-CoV-2 infection defined by positive polymerase chain reaction (PCR) testing and/or antigen test results
• referred to the pneumology clinic for a modified British Medical Research Council (mMRC) dyspnea score of 2-3 after a minimum of eight weeks of infection
• VO₂max of less than 80% of the predicted value
• receiving a medical prescription for rehabilitation following initial assessment by a pulmonologist
• being able to walk independently
• providing informed consent
• having a good internet connection (i.e., a minimum download speed of 4 Mbps and an upload speed of 4 Mbps)
• being in possession of a computer or tablet equipped with a camera enabling videoconferencing.

Exclusion Criteria

• requiring in-hospital rehabilitation at discharge
• evidence of medical instability (i.e., moderate or severe cardiac disease, ischemic or severe hemorrhagic stroke, or neurodegenerative disease, unstable fracture)
• history of severe cognitive or mental impairment
• already enrolled in another rehabilitation program

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The feasibility of study procedures	8 weeks	This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % of participants who drop out or withdraw from a study (attrition rate), % completed session (adherence rate); number of adverse events and % of participants satisfaction.

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Frailty	8 weeks	Clinical Frailty Scale (CFS) Frailty score ranging from 1 (very fit) to 9 (terminally ill)
Lower-limb endurance	8 weeks	1-minute sit-to-stand test The number of completed sit-to-stand repetitions is record.
Exercise capacity	8 weeks	Pedaling time on a cycle ergometer at constant load (i.e., 60% of maximum load).
Walking capacity	8 weeks	6-minute walk test Total distance walked in meters
Physical performance	8 weeks	Short Physical Performance Battery test Is made up of a set of three tests: standing static balance in three positions (score 0-4); lower limb strength and power through getting up and sitting on a chair(score 0-4); and walking speed at normal pace (score 0-4). And an overall score on 12.
Change in Independence in activities of daily living	8 weeks	The Barthel Index Ten items are scored with a number of points (the scoring is as follows: 0 = unable, 1 = needs assistance/help, 2 = independent), and then a final score is calculated by summing the points awarded to each functional skill. The higher the score, the more independent the patient is.
Change in Quality of life	8 weeks	Saint George's Hospital Respiratory Questionnaire (SGHRQ). Scores ranging from 0 to 100 are calculated for each component, as well as a total score that summarizes the responses to all items. A zero score indicates no impairment of quality of life, and higher scores indicate more limitations.

Trial Locations

Locations (1)

Centre hospitalier affilié universitaire régional; 🇨🇦 Trois-Rivières, Quebec, Canada