Chronic Respiratory Diseasee-mouvNCT04566523
TeleRehabilitation for Patients With Chronic Respiratory Failure.
An observational study of Chronic Respiratory Disease and Exercise, run by SOS Oxygene Mediterranee at 1 site in France.
Trial summary
It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Respiratory Disease, Exercise
- What is being tested?
- telerehabilitation
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2020to 1 Sep 2025
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from medical consultation
Who may be able to join
- chronic respiratory disease patients
- Patients with dyspnea or exercise intolerance.
- Stable patients at home.
- Patients who can use a computer (after explanations) and have adequate hearing and vision.
- Collection of the patient's non-objection
Who cannot join
- Life expectancy <3 months.
- Absolute contraindication to performing physical activity
- Hospitalization for exacerbation in the two months prior to inclusion.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cabinet de pneumologie Clinique des Cèdres
Cornebarrieu, 31700
william Heurtaux, MD, 05 62 13 32 01, william.heutaux@free.fr
Daniel Bajon, MD
About this study
Official title: Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.
It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.
- Conditions
- Chronic Respiratory Disease, Exercise
- Being tested
- telerehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telerehabilitationOther
Patients undergo an online exercise training program via a certified host of health data website.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Chronic respiratory patients who undergo a home-based exercise training program with a rehabilitation coach supervision. | |
| Tele Group | Chronic respiratory patients who undergo a home-based exercise training program online. Receives: Other: telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
exercise tolerance
number of steps during 6 minute stepper test
Measured: 3 month after inclusion
Secondary outcomes (3)
exercise tolerance
number of steps during 6 minute stepper test
Measured: 6 month and one year after inclusion
VQ-11
questionnaire, Minimum = 11, maximum = 55; higher score means worth outcome
Measured: 3, 6 month and 1 year after inclusion
physical activity quantity
questioning patients on their physical activity quantity
Measured: 3, 6 month and 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SOS Oxygene Mediterranee
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- william Heurtaux, MD, Principal investigator, Clinique des Cèdres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566523
- Sponsor's protocol ID
- 2019-102868-49
- Other IDs
- 2019
- Acronym
- e-mouv
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.
- ClinicalTrials.gov ID
- NCT04566523
- Acronym / sponsor ID
- e-mouv / 2019-102868-49
- Conditions
- Chronic Respiratory Disease, Exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- SOS Oxygene MediterraneeIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 28 Sep 2020 (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.
It is widely described in the literature that exercise training improves patients' exercise tolerance, quality of life, symptoms, anxiety and depression, regardless of the location. Despite overwhelming evidence of the benefits of exercise training, only a very small percentage of eligible people have ever completed a program. Alternative modes of exercise training are needed to improve equity of access for patients with chronic respiratory disease. So TeleRehabilitation, using information and communication technologies to provide distance exercise training services, may be an answer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Chronic respiratory patients who undergo a home-based exercise training program with a rehabilitation coach supervision. |
| Tele Group | – | Other: telerehabilitationChronic respiratory patients who undergo a home-based exercise training program online. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from medical consultation
Key inclusion criteria (5 listed)
- chronic respiratory disease patients
- Patients with dyspnea or exercise intolerance.
- Stable patients at home.
- Patients who can use a computer (after explanations) and have adequate hearing and vision.
- Collection of the patient's non-objection
Key exclusion criteria (3 listed)
- Life expectancy <3 months.
- Absolute contraindication to performing physical activity
- Hospitalization for exacerbation in the two months prior to inclusion.
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 |
|---|---|---|
| telerehabilitationPatients undergo an online exercise training program via a certified host of health data website. | Other | Tele Group |
Primary outcome
exercise tolerance
Time frame: 3 month after inclusion
number of steps during 6 minute stepper test
3 secondary outcomes
exercise tolerance
Time frame: 6 month and one year after inclusion
VQ-11
Time frame: 3, 6 month and 1 year after inclusion
physical activity quantity
Time frame: 3, 6 month and 1 year after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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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.
william Heurtaux, MD principal investigator
Clinique des Cèdres
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Disease and Exercise, run by SOS Oxygene Mediterranee at 1 site in France.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Nov 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact delphine delample, PhD (+33612155648, d.delample@sosoxygene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exercise tolerance (time frame: 3 month after inclusion). 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 28 Nov 2023.