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临床试验/NCT06871436
NCT06871436尚未招募不适用

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

Centre de l'Obesite Bernard Descottes1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年4月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
138
试验地点
1
主要终点
MVPA

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Aerobic Exercice and muscular reinforcement (Other)

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.

干预措施: Aerobic Exercice and muscular reinforcement (Other)

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.

结局指标

主要结局

MVPA

时间窗: 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).

次要结局

  • Weight(Up to 8 months)
  • Walking Distance(Up to 8 months)
  • Intensity of sessions(Up to 6 weeks)
  • Effort perception and dyspnea(Up to 8 months)
  • Lower limb strength(Up to 8 months)
  • Adhesion to telerehabilitation(Up to 6 weeks)
  • Digital tool acceptance(up to 6 weeks)
  • sedentary lifestyle(Up to 8 months)
  • Self Esteem(Up to 8 months)
  • Body perception(Up to 8 months)
  • Quality of living(up to 8 months)
  • implicit beliefs about weight loss(Up to 8 months)
  • Self-efficacy linked to physical activity(Up to 8 months)
  • Motivation to physical activity(Up to 8 months)
  • Size(Up to 8 months)
  • Fat Mass(Up to 8 months)
  • Fat Free Mass(Up to 8 months)
  • Waist circumference(Up to 8 months)
  • Body dissatisfaction(Up to 8 months)

研究者

发起方
Centre de l'Obesite Bernard Descottes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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