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Completed

NCT Number: NCT06952127

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier affilié universitaire régional

Trois-Rivières, Quebec, G8Z 3R9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation program

Other
  • 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

Primary outcomes

  1. The feasibility of study procedures

    Time frame: 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 outcomes

  1. Exercise capacity

    Time frame: 8 weeks

    Pedaling time on a cycle ergometer at constant load (i.e., 60% of maximum load).

  2. Walking capacity

    Time frame: 8 weeks

    6-minute walk test Total distance walked in meters

  3. Lower-limb endurance

    Time frame: 8 weeks

    1-minute sit-to-stand test The number of completed sit-to-stand repetitions is record.

  4. Physical performance

    Time frame: 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.

  5. Change in Independence in activities of daily living

    Time frame: 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.

  6. Change in Clinical Frailty

    Time frame: 8 weeks

    Clinical Frailty Scale (CFS) Frailty score ranging from 1 (very fit) to 9 (terminally ill)

  7. Change in Quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: TEPCO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 30, 2025
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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