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TeleRehabilitation for Patients With Chronic Respiratory Failure. (e-mouv)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04566523
Recruitment Status : Recruiting
First Posted : September 28, 2020
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
SOS Oxygene Mediterranee

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Chronic Respiratory Disease Exercise Other: telerehabilitation

Study Design
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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Benefits of TeleRehabilitation in Chronic Respiratory Failure Patients.
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Other: telerehabilitation
Patients undergo an online exercise training program via a certified host of health data website.


Outcome Measures
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Primary Outcome Measures :
  1. exercise tolerance [ Time Frame: 3 month after inclusion ]
    number of steps during 6 minute stepper test


Secondary Outcome Measures :
  1. exercise tolerance [ Time Frame: 6 month and one year after inclusion ]
    number of steps during 6 minute stepper test

  2. VQ-11 [ Time Frame: 3, 6 month and 1 year after inclusion ]
    questionnaire

  3. physical activity quantity [ Time Frame: 3, 6 month and 1 year after inclusion ]
    questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients from medical consultation
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04566523


Contacts
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Contact: delphine delample, PhD +33612155648 d.delample@sosoxygene.com

Locations
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France
Cabinet de pneumologie Clinique des Cèdres Recruiting
Cornebarrieu, France, 31700
Contact: william Heurtaux, MD    05 62 13 32 01    william.heutaux@free.fr   
Principal Investigator: Daniel Bajon, MD         
Principal Investigator: Odile Sizaret, MD         
Principal Investigator: Sylvain Droneau, MD         
Sponsors and Collaborators
SOS Oxygene Mediterranee
Investigators
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Principal Investigator: william Heurtaux, MD clinique des Cèdres
More Information
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Responsible Party: SOS Oxygene Mediterranee
ClinicalTrials.gov Identifier: NCT04566523    
Other Study ID Numbers: 2019-102868-49
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases