Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-01-22 @ 1:08 PM
Study NCT ID:
NCT03396666
Status:
TERMINATED
Last Update Posted:
2025-09-30
First Post:
2018-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Tele-rehabilitation Solution for Obese Patients.
Sponsor:
University Hospital, Montpellier
Organization:
Study Overview
Official Title:
Impact of a Mobile Tele-rehabilitation Solution on Body Composition of Obese Patients.
Status:
TERMINATED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inclusion of the last Patient
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Published data indicate that rehabilitation in obese patients can result in a loss of body fat and weight that is correlated to improved physical and psychological condition and reduced morbidity and mortality.
the Ivestigators hypothezise that the use of a mobile telerehabilitation solution will encourage the patient to adopt behavioral modifications allowing a reduction of fat mass
the Ivestigators hypothezise that the use of a mobile telerehabilitation solution will encourage the patient to adopt behavioral modifications allowing a reduction of fat mass
Detailed Description:
Obesity is one of the most important public health care problems worldwide and is associated with increased morbidity and mortality and high healthcare costs. Not all obese patients have the same metabolic risk. It is pejorated in case of increase in the fat mass (FM) and especially when it predominates at the visceral abdominal level.
Clinical trials have established the efficacy of lifestyle and behavioral interventions in obesity.
The recent development of telerehabilitation is a promising approach that has only been the subject of pilot studies Therefore, the investigators aim to test the effects of 3 months of telerehabilitation solution on fat mass evaluated by impedance analysis.
The telerehabilitation program Telemouv includes physical activity sessions with low intensity endurance training targeted at the level of maximal oxidation, nutritional monitoring, therapeutic education tools and motivational support
Patients with BMI \> 30 kg/m² will be randomized for the intervention.
The investigators also will analyse the effects of the solution on different anthropometric, metabolic,cardiovascular and psychological parameters, and on rest and exercise metabolism. Moreover, we will assess behavioural changes in physical activity and nutrition
At the end of the study, patients in the control group will be able to benefit from the telemouv solution in an ancillary study with a follow-up of three months.
For a alpha threshold of 5% and a study power of 90%, the study should include 22 patients in each group. Taking in account a possible 10% of dropout the study will need to include 25 patients by randomized arm to demonstrate an effect.
Clinical trials have established the efficacy of lifestyle and behavioral interventions in obesity.
The recent development of telerehabilitation is a promising approach that has only been the subject of pilot studies Therefore, the investigators aim to test the effects of 3 months of telerehabilitation solution on fat mass evaluated by impedance analysis.
The telerehabilitation program Telemouv includes physical activity sessions with low intensity endurance training targeted at the level of maximal oxidation, nutritional monitoring, therapeutic education tools and motivational support
Patients with BMI \> 30 kg/m² will be randomized for the intervention.
The investigators also will analyse the effects of the solution on different anthropometric, metabolic,cardiovascular and psychological parameters, and on rest and exercise metabolism. Moreover, we will assess behavioural changes in physical activity and nutrition
At the end of the study, patients in the control group will be able to benefit from the telemouv solution in an ancillary study with a follow-up of three months.
For a alpha threshold of 5% and a study power of 90%, the study should include 22 patients in each group. Taking in account a possible 10% of dropout the study will need to include 25 patients by randomized arm to demonstrate an effect.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2017-A01190-53 | REGISTRY | ID-RCB | View |