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Telerehabilitation as Follow-up for Obesity

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06871436
Acronym
OPaCTe
Enrollment
138
Registered
2025-03-12
Start date
2025-04-07
Completion date
2026-08-07
Last updated
2025-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Patients

Keywords

Telerehabilitation, Obesity, Adults, Physical Exercise, Mindsets

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.

Interventions

OTHERAerobic Exercice and muscular reinforcement

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

Sponsors

Limoges University
CollaboratorOTHER
Centre de l'Obesite Bernard Descottes
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
MVPAUp to 8 monthsTime (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).

Secondary

MeasureTime frameDescription
Walking DistanceUp to 8 monthsThe 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).
Effort perception and dyspneaUp to 8 monthsAssessment 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.
Lower limb strengthUp to 8 monthsThe 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).
Adhesion to telerehabilitationUp to 6 weeksThere will be 18 sessions to do in total and the percentage of participation will be estimated from this number of sessions.
Intensity of sessionsUp to 6 weeksIntensity 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.
Digital tool acceptanceup to 6 weeksThe 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.
sedentary lifestyleUp to 8 monthsmeasured 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.
Self EsteemUp to 8 monthsThe 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.
Body perceptionUp to 8 monthsBody 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.
WeightUp to 8 monthsweight of participants in kilograms
implicit beliefs about weight lossUp to 8 monthsQuestionnaire 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.
Self-efficacy linked to physical activityUp to 8 monthsSense 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).
Motivation to physical activityUp to 8 monthsMeasuring 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).
SizeUp to 8 monthsSize measured in Centimeters
Fat MassUp to 8 monthsfat 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).
Fat Free MassUp to 8 monthsfat 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).
Waist circumferenceUp to 8 monthswaist circumference (cm) measured by a Doctor according to a standardized protocol.
Body dissatisfactionUp to 8 monthsThe 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.
Quality of livingup to 8 monthsMeasuring 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).

Countries

France

Contacts

Primary ContactJessica TAVERNIER, Deputy Director
jtavernier@vyv3-cda.fr05.19.99.26.26
Backup ContactClément CHRISTEN, Rehabilitation framework
cchristen@vyv3-cda.fr05.19.99.26.24

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026