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NCT Number: NCT06871436

Telerehabilitation as Follow-up for Obesity

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bernard Descottes Obesity Center

Saint-Yrieix-la-Perche, 87500, France

Location contact

Claudine VASSEUR, Coordination Doctor

PRINCIPAL_INVESTIGATOR

Clément CHRISTEN, Rehabilitation framework

CONTACT

[email protected]

05.19.99.26.24

Jessica TAVERNIER, Deputy Director

CONTACT

[email protected]

05.19.99.26.26

Rémi SCHNEIDER, Ph.D student

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercice and muscular reinforcement

Other

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

Other names: Physical activity, Exercise, muscular reinforcement

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Weight

    Time frame: Up to 8 months

    weight of participants in kilograms

  2. Walking Distance

    Time frame: Up to 8 months

    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).

  3. Effort perception and dyspnea

    Time frame: Up to 8 months

    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.

  4. Lower limb strength

    Time frame: Up to 8 months

    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).

  5. Adhesion to telerehabilitation

    Time frame: Up to 6 weeks

    There will be 18 sessions to do in total and the percentage of participation will be estimated from this number of sessions.

  6. Intensity of sessions

    Time frame: Up to 6 weeks

    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.

  7. Digital tool acceptance

    Time frame: up to 6 weeks

    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.

  8. sedentary lifestyle

    Time frame: Up to 8 months

    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.

  9. Self Esteem

    Time frame: Up to 8 months

    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".

  10. Body perception

    Time frame: Up to 8 months

    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.

  11. Quality of living

    Time frame: up to 8 months

    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).

  12. implicit beliefs about weight loss

    Time frame: Up to 8 months

    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.

  13. Self-efficacy linked to physical activity

    Time frame: Up to 8 months

    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).

  14. Motivation to physical activity

    Time frame: Up to 8 months

    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).

  15. Size

    Time frame: Up to 8 months

    Size measured in Centimeters

  16. Fat Mass

    Time frame: Up to 8 months

    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).

  17. Fat Free Mass

    Time frame: Up to 8 months

    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).

  18. Waist circumference

    Time frame: Up to 8 months

    waist circumference (cm) measured by a Doctor according to a standardized protocol.

  19. Intensity of sessions

    Time frame: Up to 6 weeks

    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.

  20. Body dissatisfaction

    Time frame: Up to 8 months

    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".

Study contacts

Contact information is provided by the study sponsor or research team.

Clément CHRISTEN, Rehabilitation framework

CONTACT

[email protected]

05.19.99.26.24

Jessica TAVERNIER, Deputy Director

CONTACT

[email protected]

05.19.99.26.26

Sponsors and collaborators

Lead sponsor

Centre de l'Obesite Bernard Descottes

Other

Collaborators

  • Limoges University

Registry information

Official study title

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

Acronym: OPaCTe

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2025
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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