Telerehabilitation As Follow-up for Obesity (OPaCTe)

Telerehabilitation As a Follow-up Modality for Obese People After Returning Home Following Hospitalization

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obese Patients
• Intervention / Treatment: Other: Aerobic Exercice and muscular reinforcement

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica TAVERNIER, Deputy Director; Phone Number: 05.19.99.26.26; Email: jtavernier@vyv3-cda.fr
• Study Contact Backup: Name: Clément CHRISTEN, Rehabilitation framework; Phone Number: 05.19.99.26.24; Email: cchristen@vyv3-cda.fr

Study Locations

• France
  • Saint-Yrieix-La-Perche, France, 87500
    • Bernard Descottes Obesity Center
    • Contact: Jessica TAVERNIER, Deputy Director; Phone Number: 05.19.99.26.26; Email: jtavernier@vyv3-cda.fr
    • Contact: Clément CHRISTEN, Rehabilitation framework; Phone Number: 05.19.99.26.24; Email: cchristen@vyv3-cda.fr
    • Contact: Rémi SCHNEIDER, Ph.D student
    • Contact: Claudine VASSEUR, Coordination Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Supervised Telerehabilitation; 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; Aerobic exercise and muscle strengthening to increase weekly physical activity at moderate and vigorous intensities; Other Names: Exercise; Physical activity; muscular reinforcement
Experimental: Unsupervised Physical Activity Videos; 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; Aerobic exercise and muscle strengthening to increase weekly physical activity at moderate and vigorous intensities; Other Names: Exercise; Physical activity; muscular reinforcement
No Intervention: Contrôle Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	weight of participants in kilograms	Up to 8 months
Walking Distance	The walking test will be performed in a corridor delimited by two markers spaced 30 meters apart, following international recommendations (Baillot, Baillargeon, Brown & Langlois, 2015). The distance is calculated using markers placed on the ground at the end of the test. In addition, dyspnea and perception of effort were measured at the end of the test using the modified BORG scale (0 representing a dyspneic state or non-existent difficulty in exertion and 10 a dyspneic state or perception of maximum effort).	Up to 8 months
Effort perception and dyspnea	Assessment of perceived exertion and dyspnoea after exercise using the modified Borg scale. This scale ranges from 1 to 10. A score close to 1 shows a perception of effort and a feeling of weak dyspnea. Conversely, the higher the score, the more difficult the effort is perceived.	Up to 8 months
Lower limb strength	The chair stand-up test will be implemented with a chair placed against a wall. The subject must stand up and sit down as many times as possible from their chair in 30 seconds, without leaning against the backrest and using their hands. This version will be applied since its reliability and reproducibility is greater in subjects whose average age is less than 65 years (Orange et al., 2018).	Up to 8 months
Adhesion to telerehabilitation	There will be 18 sessions to do in total and the percentage of participation will be estimated from this number of sessions.	Up to 6 weeks
Intensity of sessions	Intensity of sessions measured with Garmin wristband to obtain reserve heart rate during sessions. Reserve heart rate will be measured with the formula : Max Heart Rate - Rest Heat Rate. Participants need to train at 60% of RHR.	Up to 6 weeks
Digital tool acceptance	The Technology Acceptance Model (TAM) questionnaire was developed in its first version by Davis (1989). The version used is a French translation by Hayotte et al., (2020). It consists of 16 items and follows a Likert scale ranging from 1 to 7 (respectively from "strongly disagree" to "strongly agree"). It measures the perception of a digital tool by subjects. This questionnaire will be used twice, first to measure the acceptability of the digital tool used during the first meeting with patients, then secondly for the acceptance of the digital tool at the end of the various remote sessions.	up to 6 weeks
sedentary lifestyle	measured with the IPAQ questionnaire. 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
Self Esteem	The "self-esteem" test is a self-questionnaire created by Rosenberg (1968) whose French version is that of Vallières and Vallerand (1990). The test consists of 10 "Likert" type items with reverse item coding. This scale is based on 4 choices organized from 1 to 4 ranging respectively from "completely disagree" to "completely agree".	Up to 8 months
Body perception	Body perception questionnaire with figure rating scale. The "Figure Rating Scale" test was developed by Stukard et al. (1983). This test measures the difference between the perceived and ideal body shape of obese people. This test consists of 9 figures numbered from 1 to 9. First, the participant must circle the figure representing the "perceived" physique (their situation at a given time) and then circle the figure representing the "ideal" physique to be achieved. An indicator is then calculated by taking the difference between the ideal score and the perceived score.	Up to 8 months
Quality of living	Measuring quality of life with the SF-36 questionnaire. The SF-36 is a quality of life questionnaire validated in France by Leplege et al. (1998). This test consists of 36 questions and is based on two dimensions of quality of life: physical and mental health. The questions cover physical mobility, limitations in the practice of daily activities, bodily pain, general health, vitality, bio-psycho-social approach and mental health. Standardized scores range from 0 (poor health) to 100 (good health).	up to 8 months
implicit beliefs about weight loss	Questionnaire to measure implicit beliefs related to the ability to regulate one's weight. This scale, proposed by Brunette (2010) is an adaptation of an instrument initially created by Dweck & Leggett (1998). Since no version translated into French existed in the literature, we will instead carry out a double translation of the original instrument using two bilingual people. Three researchers who had previously worked in the field of obesity agreed on the final version in French. This questionnaire consists of 6 items following a Likert scale ranging from 1 "Always" to 6 "Never" and measuring the subjects' relative beliefs regarding their ability to regulate their body mass.	Up to 8 months
Self-efficacy linked to physical activity	Sense of self-efficacy related to physical activity measured by a 2-subscale questionnaire. This questionnaire is the French version of the "Exercice Confidence Survey" (Sallis, 1996) validated by Eeckhout et al. (2012). It consists of 12 items following a Likert scale ranging from 1 "I know I can't" to 5 "I know I can". It is divided into two sub-dimensions, namely: measurement of adherence to PA comprising 8 items (1, 2, 3, 4, 5, 6, 7, 8) and measurement of constraints to PA practice with 4 items (9, 10, 11, 12).	Up to 8 months
Motivation to physical activity	Measuring the nature of motivation for physical activity with the EMAPS questionnaire. This French questionnaire consists of 18 items on a Likert scale ranging from 1 "Does not correspond at all" to 7 "Corresponds very strongly". It aims to measure the different types of motivation for PA in subjects suffering from chronic pathologies according to the continuum proposed by Deci and Ryan (2002). This scale is divided into 6 sub-dimensions, each measuring a specific component of motivation, each comprising 3 items: intrinsic (1, 6, 11), integrated extrinsic (7, 10, 13), identified extrinsic (4, 12, 16), introjected extrinsic (3, 14, 18), external regulation extrinsic (9, 15, 17) and amotivation (2, 5, 8).	Up to 8 months
Size	Size measured in Centimeters	Up to 8 months
Fat Mass	fat mass (%) measured in the morning on an empty stomach (whenever possible) using a Tanita impedance meter (MC-780MA P, Tanita Europe B.V., Amsterdam, The Netherlands).	Up to 8 months
Fat Free Mass	fat free mass (Kg) measured in the morning on an empty stomach (whenever possible) using a Tanita impedance meter (MC-780MA P, Tanita Europe B.V., Amsterdam, The Netherlands).	Up to 8 months
Waist circumference	waist circumference (cm) measured by a Doctor according to a standardized protocol.	Up to 8 months
Intensity of sessions	Participants will be asked to report their feelings of exertion and sensation of dyspnea during the sessions. Assessment of perceived exertion and dyspnoea after exercise using the modified Borg scale. This scale ranges from 1 to 10. A score close to 1 shows a perception of effort and a feeling of weak dyspnea. Conversely, the higher the score, the more difficult the effort is perceived.	Up to 6 weeks
Body dissatisfaction	The body dissatisfaction test comes from the Eating Disorders Inventory-II developed by Garner et al. (1983), the French version of which is the work of Criquillon-doublet et al. (1995). This test measures personal dissatisfaction with the subjects' body segments or parts. This test consists of 9 items on a 6-level Likert scale ranging from: 1 "never" to 6 "always".	Up to 8 months

Collaborators and Investigators

• Sponsor: Centre de l'Obesite Bernard Descottes
• Collaborators: Limoges University
• Investigators: Principal Investigator: Claudine VASSEUR, Coordinating doctor, Centre de l'Obesite Bernard Descottes

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2025
• Primary Completion (Estimated): February 20, 2026
• Study Completion (Estimated): August 7, 2026

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 5, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Adults; Telerehabilitation; Physical Exercise; Mindsets
• Other Study ID Numbers: N° 2024-A02428-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No