Mobile Tele-rehabilitation Solution for Obese Patients.

NCT ID: NCT03396666

Last Updated: 2025-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-17

Study Completion Date

2018-05-28

Brief Summary

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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

Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Telemouv

Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months

Group Type EXPERIMENTAL

Telemouv

Intervention Type OTHER

Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months

No intervention

Regular follow-up with advice on physical activity and nutrition

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telemouv

Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Body Mass Index \> 30 kg/m²
* Age 20-65 years

Exclusion Criteria

* Unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
* No internet access at home
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital of Montpellier

Montpellier, Montpellier, France

Site Status

Countries

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France

References

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Bughin F, Bui G, Ayoub B, Blervaque L, Saey D, Avignon A, Brun JF, Molinari N, Pomies P, Mercier J, Gouzi F, Hayot M. Impact of a Mobile Telerehabilitation Solution on Metabolic Health Outcomes and Rehabilitation Adherence in Patients With Obesity: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Dec 6;9(12):e28242. doi: 10.2196/28242.

Reference Type DERIVED
PMID: 34874887 (View on PubMed)

Other Identifiers

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2017-A01190-53

Identifier Type: REGISTRY

Identifier Source: secondary_id

RECHMPL17_0031

Identifier Type: -

Identifier Source: org_study_id

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