Clinical trial NCT06871436: Telerehabilitation as Follow-up for Obesity
Official title: Telerehabilitation as a Follow-up Modality for Obese People After Returning Home Following Hospitalization
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obese Patients
Keywords: Telerehabilitation
Obesity
Adults
Physical Exercise
Mindsets
Lead sponsor: Centre de l'Obesite Bernard Descottes
Sponsor class: OTHER
Collaborators: name: Limoges University
First posted: 2025-03-12
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this experimental study is to observed the impact of telerehabilitation modalities in obese patient after a hospitalization on physical intensity at home (MVPA). The secondary aim is to observe the evolution of clinical parameters such as anthropometric data, adherence and psychological state.


Eligibility criteria: Inclusion Criteria:

* Adult (\> 18 years old)
* BMI \> 35 or 30 Kg/m2 in case of concomitant comorbidity
* Authorization to practice physical activity for participants over 30 years old by means of a cardiac assessment and an ECG less than 6 months old carried out by a cardiologist. As part of the COBD treatment, the ECG is either: integrated into the patient file before hospitalization if the patient has seen his cardiologist staff. Either the ECG is provided in the file or carried out and analyzed by the center's cardiologist (Dr Rouffaud). The latter then authorizes or not the practice of PA.
* Complete 3-week stay in an obesity center
* Availability of equipment suitable for telerehabilitation at home
* Having given informed consent for participation in the study

Exclusion Criteria:

* Medical contraindication to PA practice defined by a doctor
* Participation in a concomitant research protocol
* For women of childbearing age, they will be informed that in the event of pregnancy occurring during participation in the research, they will not be able to continue the protocol and will withdraw from the research
* Refusal to participate in the research protocol
* Patient on weekday stay (\< 3 weeks)
* Psychiatric/psychological disorder limiting the expression of consent
* Persons under legal protection or unable to express their consent
* Inability to participate in any of the 18 Telerehabilitation sessions

Primary outcomes:
measure: MVPA
timeFrame: Up to 8 months
measure: MVPA
timeFrame: Up to 8 months
Secondary outcomes:
measure: Weight
timeFrame: Up to 8 months
measure: Walking Distance
timeFrame: Up to 8 months
measure: Effort perception and dyspnea
timeFrame: Up to 8 months
measure: Lower limb strength
timeFrame: Up to 8 months
measure: Adhesion to telerehabilitation
timeFrame: Up to 6 weeks
measure: Intensity of sessions
timeFrame: Up to 6 weeks
measure: Digital tool acceptance
timeFrame: up to 6 weeks
measure: sedentary lifestyle
timeFrame: Up to 8 months
measure: Self Esteem
timeFrame: Up to 8 months
measure: Body perception
timeFrame: Up to 8 months
measure: Quality of living
timeFrame: up to 8 months
measure: implicit beliefs about weight loss
timeFrame: Up to 8 months
measure: Self-efficacy linked to physical activity
timeFrame: Up to 8 months
measure: Motivation to physical activity
timeFrame: Up to 8 months
measure: Size
timeFrame: Up to 8 months
measure: Fat Mass
timeFrame: Up to 8 months
measure: Fat Free Mass
timeFrame: Up to 8 months
measure: Waist circumference
timeFrame: Up to 8 months
measure: Intensity of sessions
timeFrame: Up to 6 weeks
measure: Body dissatisfaction
timeFrame: Up to 8 months
Other outcomes:
Locations:
city: Saint-Yrieix-La-Perche
country: France
facility: Bernard Descottes Obesity Center
Study officials:
affiliation: Centre de l'Obesite Bernard Descottes
name: Claudine VASSEUR, Coordinating doctor
role: PRINCIPAL_INVESTIGATOR
References: