- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04566523
TeleRehabilitation for Patients With Chronic Respiratory Failure. (e-mouv)
November 21, 2023 updated by: SOS Oxygene Mediterranee
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: delphine delample, PhD
- Phone Number: +33612155648
- Email: d.delample@sosoxygene.com
Study Locations
-
-
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Cornebarrieu, France, 31700
- Recruiting
- Cabinet de pneumologie Clinique des Cèdres
-
Contact:
- william Heurtaux, MD
- Phone Number: 05 62 13 32 01
- Email: william.heutaux@free.fr
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Principal Investigator:
- Daniel Bajon, MD
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Principal Investigator:
- Odile Sizaret, MD
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Principal Investigator:
- Sylvain Droneau, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
patients from medical consultation
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Life expectancy <3 months.
- Absolute contraindication to performing physical activity
- Hospitalization for exacerbation in the two months prior to inclusion.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Patients undergo an online exercise training program via a certified host of health data website.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
exercise tolerance
Time Frame: 3 month after inclusion
|
number of steps during 6 minute stepper test
|
3 month after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
exercise tolerance
Time Frame: 6 month and one year after inclusion
|
number of steps during 6 minute stepper test
|
6 month and one year after inclusion
|
|
VQ-11
Time Frame: 3, 6 month and 1 year after inclusion
|
questionnaire, Minimum = 11, maximum = 55; higher score means worth outcome
|
3, 6 month and 1 year after inclusion
|
|
physical activity quantity
Time Frame: 3, 6 month and 1 year after inclusion
|
questioning patients on their physical activity quantity
|
3, 6 month and 1 year after inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: william Heurtaux, MD, Clinique des Cèdres
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2020
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
September 22, 2020
First Submitted That Met QC Criteria
September 22, 2020
First Posted (Actual)
September 28, 2020
Study Record Updates
Last Update Posted (Actual)
November 28, 2023
Last Update Submitted That Met QC Criteria
November 21, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-102868-49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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