NCT06952127

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

12 months

First QC Date

April 24, 2025

Last Update Submit

April 28, 2025

Conditions

Keywords

telerehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Exercise capacity

    8 weeks

  • Walking capacity

    8 weeks

  • Lower-limb endurance

    8 weeks

  • Physical performance

    8 weeks

  • Change in Independence in activities of daily living

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Telerehabilitation group

EXPERIMENTAL

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

Face-to-face group

ACTIVE COMPARATOR

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

Interventions

* 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

Face-to-face groupTelerehabilitation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier affilié universitaire régional

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2025

First Posted

April 30, 2025

Study Start

April 7, 2023

Primary Completion

March 29, 2024

Study Completion

March 29, 2024

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations