Telerehabilitation for Post COVID-19 Condition

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Long COVID, Chronic Fatigue Syndrome

Intervention / Treatment
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* Other: Telerehabilitation program based on cardiorespiratory principles


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The study design is a pre-post without a control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Group of participant receiving the hybrid telerehabilitation intervention | Other: Telerehabilitation program based on cardiorespiratory principles<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The feasibility of the program | 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 | 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 | This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (resting) | Measured with the POLAR H10 | 12 weeks | 
| Functional capacity | Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F) | 12 weeks | 
| Exercise capacity | 6-minute walk test | 12 weeks | 
| Lower-limb endurance (estimated) | 1-minute sit-to-stand test | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiorespiratory, exercise, virtual rehabilitation, post COVID-19 syndrome, fatigue, physiotherapy, post-COVID affection, post-COVID condition