Telerehabilitation for Post COVID-19 Condition

Long COVID Clinical Trial

— Telecovie  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05973136
• Other study ID #: 2022-4665
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 8, 2022

Study information

• Verified date: July 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Long COVID

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.

Locations

Country	Name	City	State
Canada	Université de Sherbrooke	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Hotel Dieu Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Fatigue and post-exercise malaise	This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.	12 weeks
Secondary	Heart rate variability (resting)	Measured with the POLAR H10	12 weeks
Secondary	Functional capacity	Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)	12 weeks
Secondary	Exercise capacity	6-minute walk test	12 weeks
Secondary	Lower-limb endurance (estimated)	1-minute sit-to-stand test	12 weeks