Sport as a Treatment in Chronic Diseases and Healthcare Sustainability: Sport 4 Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day.
研究概览
简要总结
Obesity, associated with obstructive sleep apnea (OSA) is often involved in cardiovascular diseases. In our study, we want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. The aim of this clinical trial is to determine which type of program, conducted in a digital environment associating a mobile application and individual coaching, better improves exercise habits over a 3-month period in overweight or moderate obese OSA patients.
详细描述
With automation equipment and the comfort, it has brought, less natural physical activities are required and people do not take the time to do some. Therefore, obesity, associated with obstructive sleep apnea (OSA) up to 60% of cases, has become a heavy burden on the society and the healthcare system, besides the fact that it often involves cardiovascular diseases. Assistance is urgently needed and the investigators want to promote sport practice to reduce that burden in the first place, and all associated diseases (e.g. cardiovascular diseases) consequently. In order to do that, the investigators will integrate sport in the patient pathway and support in his/her involvement. This last point means that a link between medical and sport specialists should be established, and this is missing today.
This study aims to reconcile the world of patients and the world of sport, by offering a trajectory and an organization that help patients to initiate physical activity.
The investigators plan to measure the physical activity of overweight or moderate obese, apneic patients in the different programs at the end of the 3-month period by physical activity objective parameters: number of steps/day.
The secondary objectives of this study are to:
- Evaluate the effect of the different programs of sport "prescription" on patient motivation, over a 3-month period by a motivational questionnaire.
- Analyze the cost effectiveness of the different programs of sport "prescription" over a 3-month period.
- Evaluate the effect of the different programs of sport "prescription" on weight and blood pressure (BP), assessed by home self-measurements each month, over a 3-month period and recorded in the application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
open, proof of concept study in overweight or moderate obese OSA patients,
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •25 y ≤ age ≤ 70 y
- •27 < BMI < 32
- •Weight < 120 kg
- •Apneic patient (Apnea-hypopnea index > 15/h) treated or not by CPAP (continuous positive airway pressure )
- •Be able to practice sport (according to a Cardiologist decision)
- •Be able to use the personal health monitoring devices jointly to a personal Touch phone
- •Consenting patient based around Grenoble France
- •Be legally able to give consent
- •Person affiliated to social security
排除标准
- •Being unable to understand, follow objectives and methods due to cognition or language problems
- •Pregnant women, feeding and parturient
- •Physical activity score > 9, calculated by Baecke's questionnaire (Annex 1)
- •Subject under administrative or judicial control, person who are protected under the act.
结局指标
主要结局
The physical activity of overweight or moderate obese OSA patients in the different programs will be estimated by physical activity objective parameters: number of steps/day.
时间窗: at the end of the 3-month period
The physical activity of overweight or moderate obese OSA patients in the different programs during the 3-month period will be estimated by physical activity objective parameters: heart rate, physical activity type, motion cadence (number of steps/day), energy expenditure, and sleep stage (measured at the end, by an actigraph integrated in the watch).
次要结局
- Evaluation of the effect of the different programs of sport "prescription" on weight and blood pressure (BP)(each month, over 3 months)
- Evaluation of the effect of the different programs of sport "prescription" on patient motivation(over a 3-month period)
- Cost effectiveness analysis of the different programs of sport "prescription"(over a 3-month period.)