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Completed

NCT Number: NCT05973136

Telerehabilitation for Post COVID-19 Condition

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.

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Key information

Conditions

Long COVID Behavior COVID-19 Chronic Disease Chronic Fatigue Syndrome Coronaviridae Infections Coronavirus Infections Disease Attributes Encephalomyelitis Fatigue Fatigue Syndrome, Chronic Infections Lung Diseases Motor Activity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular 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 Signs and Symptoms Virus Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Telerehabilitation program based on cardiorespiratory principles

Other

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.

Primary outcomes

  1. 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

  2. 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.

  3. Fatigue and post-exercise malaise

    Time frame: 12 weeks

    This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.

Secondary outcomes

  1. Heart rate variability (resting)

    Time frame: 12 weeks

    Measured with the POLAR H10

  2. Functional capacity

    Time frame: 12 weeks

    Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)

  3. Exercise capacity

    Time frame: 12 weeks

    6-minute walk test

  4. Lower-limb endurance (estimated)

    Time frame: 12 weeks

    1-minute sit-to-stand test

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • Hotel Dieu Hospital

Registry information

Official study title

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

Acronym: Telecovie

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

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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