NCT05372250招募中不适用
Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy
Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年5月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound
研究概览
简要总结
The EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound.
The investigators suppose that the course of the right diaphragmatic hemicupola would be increased by an increasingly horizontal position (gradual increase in the diaphragmatic excursion from standing to lying down).
If this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •to have a BMI greater than or equal to 30;
- •to have not had intense physical activity during the hour preceding the measurements;
- •to be enrolled in a social security plan;
- •to give a written consent;
- •to have underwent a pre-inclusion medicalexamination.
排除标准
- •to have a respiratory pathology unrelated to obesity (sleep apnea syndrome, obesity-hypoventilation syndrome, restrictive ventilatory syndrome with no other known cause);
- •to have a cardiac pathology not stabilized by drug treatment and/or resulting in heart failure and/or requiring the fitting of a pacemaker or defibrillator;
- •to have a chronic inflammatory disease (rheumatoid arthritis, Crohn's disease, cirrhosis, etc.);
- •to have a chest deformity (kyphoscoliosis, funnel chest, etc.);
- •to be anactive smoking or former smoker (stopped for less than 3 months and total consumption > 10 pack-years);
- •to have an history of major surgery, surgery under general anesthesia for less than 3 months, or minimally invasive surgery for less than 1 year of the thoraco-abdomino-pelvic compartments;
- •to have a known sensitivity to monopropylene glycol (substance present in the sterile ultrasound gel);
- •temperature of the room in which the ultrasound measurements are carried out below 20°C or above 25°C;
- •subject under a measure of legal protection.
结局指标
主要结局
Diaphragmatic excursion in centimeters in the 4 positions measured by ultrasound
时间窗: Day 0
次要结局
- Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and waist circumference in centimeters.(Day 0)
- Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and BMI in kg/m². Weight in kilograms and height in meters will be combined to report BMI in kg/m².(Day 0)
- Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and sex of the participant (male/female).(Day 0)
- Correlation between measurement of diaphragmatic excursion in centimeters by ultrasound and weight in kilograms.(Day 0)
- Comfort of the ultrasound examination felt by the patient via a questionnaire(Day 0)
研究者
Marine MERVELET
Principal Investigator
Central Hospital, Nancy, France
研究点 (2)
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