Obese PatientsOPaCTeNCT06871436
Telerehabilitation as Follow-up for Obesity
A study testing Aerobic Exercice and muscular reinforcement in people with Obese Patients, run by Centre de l'Obesite Bernard Descottes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obese Patients
- What is being tested?
- Aerobic Exercice and muscular reinforcement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- 7 Apr 2025to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Bernard Descottes Obesity Center
Saint-Yrieix-la-Perche, 87500
Jessica TAVERNIER, Deputy Director, 05.19.99.26.26, jtavernier@vyv3-cda.fr
Clément CHRISTEN, Rehabilitation framework, 05.19.99.26.24, cchristen@vyv3-cda.fr
About this study
Official title: 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.
- Conditions
- Obese Patients
- Being tested
- Aerobic Exercice and muscular reinforcement
- Keywords
- Telerehabilitation, Obesity, Adults, Physical Exercise, Mindsets
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercice and muscular reinforcementOther
Also called Physical activity, Exercise, muscular reinforcement
Aerobic exercise and muscle strengthening to increase weekly physical activity at moderate and vigorous intensities
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 8 months
Secondary outcomes (20)
Weight
weight of participants in kilograms
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Up to 8 months
Size
Size measured in Centimeters
Measured: 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).
Measured: 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).
Measured: Up to 8 months
Waist circumference
waist circumference (cm) measured by a Doctor according to a standardized protocol.
Measured: 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.
Measured: 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".
Measured: Up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start7 Apr 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de l'Obesite Bernard Descottes
- Sponsor type
- University, hospital or other
- Collaborators
- Limoges University
- Responsible party
- Sponsor
- Investigators
- Claudine VASSEUR, Coordinating doctor, Principal investigator, Centre de l'Obesite Bernard Descottes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871436
- Sponsor's protocol ID
- N° 2024-A02428-39
- Acronym
- OPaCTe
- Status last verified
- Mar 2025
- First submitted
- 10 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telerehabilitation as a Follow-up Modality for Obese People After Returning Home Following Hospitalization
- ClinicalTrials.gov ID
- NCT06871436
- Acronym / sponsor ID
- OPaCTe / N° 2024-A02428-39
- Conditions
- Obese Patients
- Keywords
- Telerehabilitation, Obesity, Adults, Physical Exercise, Mindsets
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Centre de l'Obesite Bernard DescottesUniversity, hospital or other
- Collaborators
- Limoges University
- Study start
- 7 Apr 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supervised Telerehabilitation | Experimental | Other: Aerobic Exercice and muscular reinforcementParticipants 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. |
| Unsupervised Physical Activity Videos | Experimental | Other: Aerobic Exercice and muscular reinforcementParticipants 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercice and muscular reinforcementAlso: Physical activity, Exercise, muscular reinforcementAerobic exercise and muscle strengthening to increase weekly physical activity at moderate and vigorous intensities | Other | Supervised Telerehabilitation, Unsupervised Physical Activity Videos |
Primary outcome
MVPA
Time frame: Up to 8 months
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).
MVPA
Time frame: Up to 8 months
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.
20 secondary outcomes
Weight
Time frame: Up to 8 months
Walking Distance
Time frame: Up to 8 months
Effort perception and dyspnea
Time frame: Up to 8 months
Lower limb strength
Time frame: Up to 8 months
Adhesion to telerehabilitation
Time frame: Up to 6 weeks
Intensity of sessions
Time frame: Up to 6 weeks
Digital tool acceptance
Time frame: up to 6 weeks
sedentary lifestyle
Time frame: Up to 8 months
Self Esteem
Time frame: Up to 8 months
Body perception
Time frame: Up to 8 months
Quality of living
Time frame: up to 8 months
implicit beliefs about weight loss
Time frame: Up to 8 months
Self-efficacy linked to physical activity
Time frame: Up to 8 months
Motivation to physical activity
Time frame: Up to 8 months
Size
Time frame: Up to 8 months
Fat Mass
Time frame: Up to 8 months
Fat Free Mass
Time frame: Up to 8 months
Waist circumference
Time frame: Up to 8 months
Intensity of sessions
Time frame: Up to 6 weeks
Body dissatisfaction
Time frame: Up to 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claudine VASSEUR, Coordinating doctor principal investigator
Centre de l'Obesite Bernard Descottes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercice and muscular reinforcement in people with Obese Patients, run by Centre de l'Obesite Bernard Descottes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica TAVERNIER, Deputy Director (05.19.99.26.26, jtavernier@vyv3-cda.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVPA (time frame: Up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.