Clinical trial NCT05973136: Telerehabilitation for Post COVID-19 Condition
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Chronic Fatigue Syndrome
Keywords: cardiorespiratory
exercise
virtual rehabilitation
post COVID-19 syndrome
fatigue
physiotherapy
post-COVID affection
post-COVID condition
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Hotel Dieu Hospital
First posted: 2023-08-02
Enrollment: 7
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study design is a pre-post without a control group
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The feasibility of the program
timeFrame: 12 weeks
measure: Acceptability
timeFrame: 12 weeks
measure: Fatigue and post-exercise malaise
timeFrame: 12 weeks
Secondary outcomes:
measure: Heart rate variability (resting)
timeFrame: 12 weeks
measure: Functional capacity
timeFrame: 12 weeks
measure: Exercise capacity
timeFrame: 12 weeks
measure: Lower-limb endurance (estimated)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Livia Pinheiro Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: