Long COVIDTelecovieNCT05973136
Telerehabilitation for Post COVID-19 Condition
A study testing Telerehabilitation program based on cardiorespiratory principles in people with Long COVID and Chronic Fatigue Syndrome, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Long COVID, Chronic Fatigue Syndrome
- What is being tested?
- Telerehabilitation program based on cardiorespiratory principles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2022to 8 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30
- Inability to perform or understand study procedures
- Medical contraindication
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Telerehabilitation program based on cardiorespiratory principles
- Keywords
- cardiorespiratory, exercise, virtual rehabilitation, post COVID-19 syndrome, fatigue, physiotherapy, post-COVID affection, post-COVID condition
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Fatigue Syndrome, Chronic, Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation program based on cardiorespiratory principlesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group of participant receiving the hybrid telerehabilitation intervention Receives: Other: Telerehabilitation program based on cardiorespiratory principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 weeks
Fatigue and post-exercise malaise
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
Measured: 12 weeks
Secondary outcomes (4)
Heart rate variability (resting)
Measured with the POLAR H10
Measured: 12 weeks
Functional capacity
Strength, assistance with walking, rising from a chair, climbing stairs, and falls questionnaire (SARC-F)
Measured: 12 weeks
Exercise capacity
6-minute walk test
Measured: 12 weeks
Lower-limb endurance (estimated)
1-minute sit-to-stand test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Apr 2022
- Primary completion8 Aug 2022
- Study completion8 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study design is a pre-post without a control group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Hotel Dieu Hospital
- Responsible party
- Sponsor
- Investigators
- Livia Pinheiro Carvalho, PhD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973136
- Sponsor's protocol ID
- 2022-4665
- Acronym
- Telecovie
- Status last verified
- Jul 2023
- First submitted
- 25 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05973136
- Acronym / sponsor ID
- Telecovie / 2022-4665
- Conditions
- Long COVID, Chronic Fatigue Syndrome
- Keywords
- cardiorespiratory, exercise, virtual rehabilitation, post COVID-19 syndrome, fatigue, physiotherapy, post-COVID affection, post-COVID condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Hotel Dieu Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 8 Aug 2022 (actual)
- Study completion
- 8 Aug 2022 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is a pre-post without a control group
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Telerehabilitation program based on cardiorespiratory principlesGroup of participant receiving the hybrid telerehabilitation intervention |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment: Mini-Mental State Examination (MMSE) ≤24/30
- Inability to perform or understand study procedures
- Medical contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation program based on cardiorespiratory principlesThe 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. | Other | Intervention group |
Primary outcome
The feasibility of the program
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
This will be evaluated with the Fatigue severity scare and De Paul Symptom Questionnaire.
4 secondary outcomes
Heart rate variability (resting)
Time frame: 12 weeks
Functional capacity
Time frame: 12 weeks
Exercise capacity
Time frame: 12 weeks
Lower-limb endurance (estimated)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Livia Pinheiro Carvalho, PhD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation program based on cardiorespiratory principles in people with Long COVID and Chronic Fatigue Syndrome, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of the program (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.