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

Pilot Study Evaluating the Feasibility and Appropriateness of a Telerehabilitation Exercise Program in People With Post-COVID-19 Sequelae: a Single-center Randomized Trial.

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

Study Overview

• Status: Completed
• Conditions: Long COVID; Long COVID-19 Syndrome; Long COVID Syndrome
• Intervention / Treatment: Other: Rehabilitation program

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Centre hospitalier affilié universitaire régional

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation group; Rehabilitation program including cardiovascular, muscular and balance training and, if necessary, respiratory physiotherapy using the Teams platform supervised by a certified kinesiologist. The rehabilitation will be conducted 3 times a week for 8 weeks in group of 5 or 6 persons.	Other: Rehabilitation program; 5-minute warm-up including easy global exercises; 5 resistance training exercises targeting upper and lower muscle groups; 30 secondes break between sets; Cooldown with breathing and stretching exercises
Active Comparator: Face-to-face group; Rehabilitation program including cardiovascular, muscular and balance training and, if necessary, respiratory physiotherapy at the university kinesiology clinic supervised by a certified kinesiologist. The rehabilitation will be conducted 3 times a week for 8 weeks in group of 5 or 6 persons.	Other: Rehabilitation program; 5-minute warm-up including easy global exercises; 5 resistance training exercises targeting upper and lower muscle groups; 30 secondes break between sets; Cooldown with breathing and stretching exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The feasibility of study procedures	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise capacity	Pedaling time on a cycle ergometer at constant load (i.e., 60% of maximum load).	8 weeks
Walking capacity	6-minute walk test Total distance walked in meters	8 weeks
Lower-limb endurance	1-minute sit-to-stand test The number of completed sit-to-stand repetitions is record.	8 weeks
Physical performance	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.	8 weeks
Change in Independence in activities of daily living	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.	8 weeks
Change in Clinical Frailty	Clinical Frailty Scale (CFS) Frailty score ranging from 1 (very fit) to 9 (terminally ill)	8 weeks
Change in Quality of life	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.	8 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: April 24, 2025
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): April 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: telerehabilitation
• Additional Relevant MeSH Terms: Post-Infectious Disorders; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Post-Acute COVID-19 Syndrome; Syndrome
• Other Study ID Numbers: 2023-667; 889 (Registry Identifier: Base de données des projets de recherche du CIUSSS-MCQ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No