Contribution of the Evaluation of Body Composition by Connected Scale in the Effectiveness of a Reconditioning Program Through Physical Activity Adapted for Patients Suffering From Chronic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient.
研究概览
简要总结
The goal of this interventional study is to evaluate the impact of the use of a connected impedance scale on the physical and mental quality of life of patients suffering from chronic diseases and participating in a physical activity rehabilitation program. The main objective is to know if a regular monitoring of the evolution of body composition parameters recorded by the connected scale would allow patients participating in the Physical Activity rehabilitation program at Hôtel-Dieu to follow in real time the effects of such program, not on weight itself but on body composition, and that this would contribute to a better perception of physical and mental quality of life at the end of the program 90 Participants will be randomized in two groups :
- Control group (N = 45) : routine care
- Interventionnal group (N=45) : routine care + use of connected scale All participants will undergo physical activity rehabilitation program during 6 weeks.
Patients will be see again at 6 months, and the following parameters will be comparer between the two groups :
- SF-36 questionnaire
- Ricci & Gagnon questionnaire
- 6MWT
- 30 sec sit-to stand test
- Ito-Shirado test
- Sorensen test
- Handgrip test
- MaxV02
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient (male or female) aged 18 and over
- •Patient able to express free, informed and written consent
- •Patient participating in the physical activity rehabilitation program at the CIMS of the Hôtel Dieu
- •Patient suffering from a known, stable and diagnosed chronic disease
- •Patient autonomous in taking treatments for their ALD
- •Patient affiliated to a social security system
排除标准
- •Patient under legal protection (guardianship, curatorship)
- •Patient deprived of liberty by a judicial or administrative decision
- •Patient with functional limitations that do not allow a physical assessment or result in a walking distance < 350 m during the HDJ for admission to the program
- •Patient with suspected cardiac pathology during the HDJ for admission to the program
- •Patient with episode of decompensation or exacerbation
- •Patient with a pacemaker or implantable automatic defibrillator
- •Pregnant women
研究组 & 干预措施
Standard follow-up group
Routine care
Connected scale group
Routine care + use of connected scale during 6 months
干预措施: Body Comp Pro connected scale (Withings manufacturer) (Device)
结局指标
主要结局
Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 months for each patient.
时间窗: 6 months from initiation of physical activity rehabilitation program
Short Form 36 questionnaire (0 - 100 ; Higher mean better outcome)
次要结局
- Measurement of Handgrip test at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)
- Measurement of Sorensen test at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)
- Measurement of the physical and mental quality of life score using the Short Form 36 questionnaire at 6 weeks for each patient.(6 weeks from initiation of physical activity rehabilitation program)
- Measurement of 30 sec sit-to-stand test at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)
- Measurement of Ito-Shirado test at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)
- Measurement of VO2max at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)
- Measurement of daily physical activity level by the Ricci & Gagnon questionnaire at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)
- Measurement of 6 minute walk test (6MWT) at 6 months for each patient(6 months from initiation of physical activity rehabilitation program)