Telerehabilitation for Post COVID-19 Condition

NCT ID: NCT05973136

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-08-08

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.

Conditions

Long COVID; Chronic Fatigue Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Group of participant receiving the hybrid telerehabilitation intervention

Group Type: EXPERIMENTAL

Telerehabilitation program based on cardiorespiratory principles

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hotel Dieu Hospital

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Livia Pinheiro Carvalho, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

2022-4665

Identifier Type: -

Identifier Source: org_study_id