Telerehabilitation for Post COVID-19 Condition (Telecovie)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Fatigue Syndrome; Long COVID
• Intervention / Treatment: Other: Telerehabilitation program based on cardiorespiratory principles

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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Université de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: Hotel Dieu Hospital
• Investigators: Principal Investigator: Livia Pinheiro Carvalho, PhD, Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): August 8, 2022
• Study Completion (Actual): August 8, 2022

Study Registration Dates

• First Submitted: July 25, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; exercise; physiotherapy; virtual rehabilitation; cardiorespiratory; post COVID-19 syndrome; post-COVID affection; post-COVID condition
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Chronic Disease; Neuroinflammatory Diseases; Post-Infectious Disorders; COVID-19; Fatigue; Fatigue Syndrome, Chronic; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022-4665

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No