Telerehabilitation for Post COVID-19 Condition (Telecovie)

July 28, 2023 updated by: Université de Sherbrooke

A Pilot Study to Evaluate the Implantation and the Impact of a Hybrid Telerehabilitation Program Based on Cardiopulmonary Rehabilitation Principles for People With Post-COVID Affection

Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Telerehabilitation is a great alternative to offering care during a global pandemic. 85% of patients with COVID-19 report persistent symptoms up to 8 months after the infection. There are no clear recommendations for post-covid rehabilitation. The aims of the study are (1) to test the logistic aspect of implanting a hybrid rehabilitation program and (2) to evaluate the acceptability and the potential impact of the program on treating patients with functional limitations and persistent fatigue symptoms. It's a pre and post-study without a control group. The intervention will be based on cardiopulmonary rehabilitation principles and will be administered for 12 weeks. Fatigue, post-exertional malaise, and functional/exercise capacities will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Universite de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Living in the community
  • Living near Sherbrooke (<50km)
  • Having a diagnostic of COVID-19 confirmed (PCR) and post-COVID syndrome (according to the World Health Organization criteria)
  • Being aged between 25 and 65 years old
  • Having access to internet at home
  • Living with a family member/caregiver or having a telephone or a medical alert system (in case of emergency)
  • Reporting persistent fatigue symptoms according to the Fatigue Severity Scale (FSS) (score≥4/7)
  • Reporting functional limitations according to the Post-COVID-19 Functional Status scale (PCFS (score ≥2/4);
  • Being able to give free and informed consent (adequate understanding of the study protocol);
  • Agreeing to perform a pulmonary function test, an exercise stress test, and an ergospirometric exercise test (adequate understanding of steps and procedures);
  • Having a low exercise capacity and moderate-to-severe cardiovascular risk <7 metabolic equivalent of a task (MET) or ≤9 if significant reduction of self-reported exercise tolerance according to the stress test performed on a treadmill - Cornell protocol);
  • Having no other potential explanatory causes for fatigue or reduced exercise capacity according to medical evaluation

Exclusion Criteria:

  • Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30
  • Inability to perform or understand study procedures
  • Medical contraindication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
Group of participant receiving the hybrid telerehabilitation intervention
Other: Telerehabilitation program based on cardiorespiratory principles
The intervention consists of a hybrid program. The participant will receive rehabilitation sessions in presence (aerobic component of the intervention based on maximal oxygen uptake measured before intervention by means on a ergospirometric test) and at home via a telerehabilitation platform. The length of the intervention is 12 weeks. For the in-presence sessions, they are going to be 75 minutes, 2x/week. For the at-distance sessions, they are going to be 45 minutes, 1x/week in groups of 3 to 4 participants. The intervention will consist of a warm-up, endurance, postural, and strengthening exercises, cool down and respiratory exercises. An exercise book with final recommendations is provided to the participants at the end of the intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The feasibility of the program
Time Frame: 12 weeks

This will be evaluated by % of participants that accept to participate in the study (recruitment rate), % who completed the intervention (retention rate) and % completed session/anticipated session (adherence).

The security of the program will be evaluated by the number of falls or near fall.

Technical difficulty
12 weeks
Acceptability
Time Frame: 12 weeks
The satisfaction of the participants will be evaluated with a questionnaire (14 questions). The questionnaire will assess patients' satisfaction with the professional, the services and the organization - Telemedicine Satisfaction. Qualitative open-ended questions will be used to determine appreciation and challenges encountered.
12 weeks
Fatigue and post-exercise malaise
Time Frame: 12 weeks
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate variability (resting)
Time Frame: 12 weeks
Measured with the POLAR H10
12 weeks
Functional capacity
Time Frame: 12 weeks
Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)
12 weeks
Exercise capacity
Time Frame: 12 weeks
6-minute walk test
12 weeks
Lower-limb endurance (estimated)
Time Frame: 12 weeks
1-minute sit-to-stand test
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hotel Dieu Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Livia Pinheiro Carvalho, PhD, Universite de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-4665

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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