Telerehabilitation as Follow-up for Obesity

NCT06871436 | Not Yet Recruiting

• 1 other identifier: N° 2024-A02428-39
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Obese Patients

Keywords

Telerehabilitation; Obesity; Adults; Physical Exercise; Mindsets

Outcome Measures

Primary Outcomes (2)

• MVPA

  Time (min/s) of physical activity at moderate and/or vigorous intensity. This is done with a trivial accelerometer and measures with an equation (Garmin) the MVPA practice time over a week and gives a value in minutes per week. It enables us to understand whether or not a participant is achieving the recommended level of physical activity (150 min/week at moderate or vigorous intensity).

  Up to 8 months

• MVPA

  This questionnaire by Craig et al (2003) consists of 27 questions divided into 5 parts. In each part, the participant is asked to quantify the amount of time in minutes/hours/days spent in PA. The first part comprises questions 1 to 7 and covers all physical activity practised in a professional context. The second part, questions 8 to 13, covers physical activity related to daily commuting (walking, cycling, driving, etc.) (to work, to the stores, etc.). The third part comprises questions 14 to 19 and covers activities related to housework, home maintenance, time spent with family, etc. The fourth part, questions 20 to 25, deals with physical activity related to leisure, sport and free time. Finally, the fifth section includes questions 26 to 27 and covers time spent sitting or lying down during the day.

  Up to 8 months

Secondary Outcomes (20)

• Weight

  Up to 8 months

• Walking Distance

  Up to 8 months

• Effort perception and dyspnea

  Up to 8 months

• Lower limb strength

  Up to 8 months

• Adhesion to telerehabilitation

  Up to 6 weeks

Study Arms (3)

Supervised Telerehabilitation

EXPERIMENTAL

Participants will have access to the Follow SURG application to monitor their health at home. In addition, participants will be asked to wear the activity wristband daily (except when sleeping) and to download the GARMIN Connect app on their smartphone to update their physical activity data. They will participate in telerehabilitation sessions with a professional via videoconference using the AXOMOVE telehealth application. These sessions will take place three times a week, for 60 minutes, from 12pm to 13pm and 5pm to 6pm on Mondays, Wednesdays and Fridays. Each telerehabilitation group will follow these sessions live. Telerehabilitation sessions include a 10-minute warm-up, 40 minutes of circuit training, 5 minutes of stretching and 5 minutes of discussion with the professional.

Other: Aerobic Exercice and muscular reinforcement

Unsupervised Physical Activity Videos

EXPERIMENTAL

Participants will be able to use the Follow SURG application to monitor their health at home. In terms of accessibility, this will be comprehensive, with access to informative content proposed by paramedical professionals such as psychomotricians, dieticians and psychologists, as well as content made available in the current COBD follow-up. In addition, participants will be asked to wear the activity wristband on a daily basis (except when sleeping) and to download the GARMIN Connect application onto their smartphone in order to update their PA data. Participants will be asked to carry out APA sessions 3 times a week, using videos produced in advance by a professional. Videos will include 10 min of warm-up, 40 min of circuit training (following the same modalities as those defined in the "Telerehabilitation" section) and 10 min of stretching.

Other: Aerobic Exercice and muscular reinforcement

Contrôle Group

NO INTERVENTION

Participants will be able to use the Follow SURG application to monitor their health at home. Access to the Follow SURG application will be restricted to informative content provided by paramedical professionals such as psychomotricians, dieticians and psychologists. In addition, participants will be asked to wear the activity wristband on a daily basis (except when sleeping) and to download the GARMIN Connect app on their smartphone in order to update their physical activity data. In addition, reminders to practice physical activity will be provided on the Follow SURG app 3 times a week.

Interventions

Aerobic Exercice and muscular reinforcement OTHER

Aerobic exercise and muscle strengthening to increase weekly physical activity at moderate and vigorous intensities

Also known as: Physical activity, Exercise, muscular reinforcement

Supervised Telerehabilitation; Unsupervised Physical Activity Videos

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de l'Obesite Bernard Descottes: lead
• Limoges University: collaborator

Study Sites (1)

Bernard Descottes Obesity Center

Saint-Yrieix-la-Perche, 87500, France

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Claudine VASSEUR, Coordinating doctor

  Centre de l'Obesite Bernard Descottes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica TAVERNIER, Deputy Director

CONTACT

05.19.99.26.26; jtavernier@vyv3-cda.fr

Clément CHRISTEN, Rehabilitation framework

CONTACT

05.19.99.26.24; cchristen@vyv3-cda.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 12, 2025
• Study Start: April 7, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): August 7, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Locations

FR (1)