Back to resultsTelerehabilitation for Post COVID-19 Condition (Telecovie)
Primary Purpose
Long COVID, Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telerehabilitation program based on cardiorespiratory principles
Sponsored by
About this trial
This is an interventional treatment trial for Long COVID focused on measuring cardiorespiratory, exercise, virtual rehabilitation, post COVID-19 syndrome, fatigue, physiotherapy, post-COVID affection, post-COVID condition
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
Sites / Locations
- Université de Sherbrooke
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention group
Arm Description
Group of participant receiving the hybrid telerehabilitation intervention
Outcomes
Primary Outcome Measures
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
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.
Fatigue and post-exercise malaise
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
Secondary Outcome Measures
Heart rate variability (resting)
Measured with the POLAR H10
Functional capacity
Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)
Exercise capacity
6-minute walk test
Lower-limb endurance (estimated)
1-minute sit-to-stand test
Full Information
NCT ID
NCT05973136
First Posted
July 25, 2023
Last Updated
July 28, 2023
Sponsor
Université de Sherbrooke
Collaborators
Hotel Dieu Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05973136
Brief Title
Telerehabilitation for Post COVID-19 Condition
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 8, 2022 (Actual)
Study Completion Date
August 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke
Collaborators
Hotel Dieu Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Long COVID, Chronic Fatigue Syndrome
Keywords
cardiorespiratory, exercise, virtual rehabilitation, post COVID-19 syndrome, fatigue, physiotherapy, post-COVID affection, post-COVID condition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The study design is a pre-post without a control group
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Group of participant receiving the hybrid telerehabilitation intervention
Intervention Type
Other
Intervention Name(s)
Telerehabilitation program based on cardiorespiratory principles
Intervention Description
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.
Primary Outcome Measure Information:
Title
The feasibility of the program
Description
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
Time Frame
12 weeks
Title
Acceptability
Description
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.
Time Frame
12 weeks
Title
Fatigue and post-exercise malaise
Description
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Heart rate variability (resting)
Description
Measured with the POLAR H10
Time Frame
12 weeks
Title
Functional capacity
Description
Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)
Time Frame
12 weeks
Title
Exercise capacity
Description
6-minute walk test
Time Frame
12 weeks
Title
Lower-limb endurance (estimated)
Description
1-minute sit-to-stand test
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Livia Pinheiro Carvalho, PhD
Organizational Affiliation
Université de Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Telerehabilitation for Post COVID-19 Condition
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