Telerehabilitation for Post COVID-19 Condition

NCT05973136 | Completed

• 1 other identifier: 2022-4665
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Long COVID; Chronic Fatigue Syndrome

Keywords

cardiorespiratory; exercise; virtual rehabilitation; post COVID-19 syndrome; fatigue; physiotherapy; post-COVID affection; post-COVID condition

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Heart rate variability (resting)

  12 weeks

• Functional capacity

  12 weeks

• Exercise capacity

  12 weeks

• Lower-limb endurance (estimated)

  12 weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

Group of participant receiving the hybrid telerehabilitation intervention

Other: Telerehabilitation program based on cardiorespiratory principles

Interventions

Telerehabilitation program based on cardiorespiratory principles 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.

Intervention group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30
• Inability to perform or understand study procedures
• Medical contraindication

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Hotel Dieu Hospital: collaborator

Study Sites (1)

Université de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Fatigue Syndrome, Chronic; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Behavior; Signs and Symptoms

Study Officials

• Livia Pinheiro Carvalho, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a pre-post without a control group

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: April 1, 2022
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-07

Locations

CA (1)