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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04566523
Other study ID # 2019-102868-49
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date September 1, 2025

Study information

Verified date November 2023
Source SOS Oxygene Mediterranee
Contact delphine delample, PhD
Phone +33612155648
Email d.delample@sosoxygene.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 220
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
France Cabinet de pneumologie Clinique des Cèdres Cornebarrieu

Sponsors (1)

Lead Sponsor Collaborator
SOS Oxygene Mediterranee

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary exercise tolerance number of steps during 6 minute stepper test 3 month after inclusion
Secondary exercise tolerance number of steps during 6 minute stepper test 6 month and one year after inclusion
Secondary VQ-11 questionnaire, Minimum = 11, maximum = 55; higher score means worth outcome 3, 6 month and 1 year after inclusion
Secondary physical activity quantity questioning patients on their physical activity quantity 3, 6 month and 1 year after inclusion
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