Telecovie: Telerehabilitation for Post COVID-19 Condition

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT05973136

Collaborator

Hotel Dieu Hospital (Other)

Enrollment

Location

Arm

4.2

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Long COVID Chronic Fatigue Syndrome	Other: Telerehabilitation program based on cardiorespiratory principles	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study design is a pre-post without a control groupThe study design is a pre-post without a control group

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Apr 1, 2022

Actual Primary Completion Date :

Aug 8, 2022

Actual Study Completion Date :

Aug 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

The feasibility of the program [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
Acceptability [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.
Fatigue and post-exercise malaise [12 weeks]
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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