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临床试验/NCT04527796
NCT04527796终止不适用

Influence of a Residential Rehabilitation Program on Body Composition in Patients With Cystic Fibrosis (Children and Adults)

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
39
试验地点
1
主要终点
Weight change

研究概览

简要总结

The aim is to evaluate the impact of a 3-week lasting residential rehabilitation program for patients with cystic fibrosis on their nutritional status measured as BMI and body composition and pulmonary function.

详细描述

Cystic fibrosis Patients following a residential rehabilitation program consisting of dietary adaptation, physical therapy for airway drainage and supervised inhalation therapy and physical activity for at least 3 weeks are asked to participate. Weight, height, body composition and pulmonary function will be measured at start and end of the program. Dietary intake during the program is calculated based on a 2 day weighed intake diary and physical activity will be measured with the "SenseWear pro 3" armband.

研究设计

研究类型
Observational

入排标准

年龄范围
6 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cystic fibrosis
  • stay at the rehabilitation center for at least 3 consecutive weeks

排除标准

  • steroid use
  • absence from the program for more than 2 consecutive days

结局指标

主要结局

Weight change

时间窗: day 0 and day 21 (start and end of the rehabilitation program)

Scale weighed weight (kg) converted in standard deviations of normal population of normal populations

pulmonary function change

时间窗: day 0 and day 21 (start and end of the rehabilitation program)

Forced Vital capacity (% of normal)

body composition change

时间窗: day 0 and day 21 (start and end of the rehabilitation program)

Dual energy X-ray absorptiometry measured fat free mass (kg/m\*2)

Body mass index change

时间窗: day 0 and day 21 (start and end of the rehabilitation program)

calculated based on weight and height (kg/m\*2) converted in standard deviations

次要结局

  • Physical activity(Week 1)
  • dietary intake(2 days/week for 3 consecutive weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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