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临床试验/NCT00231686
NCT00231686已完成2 期

Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN

Julius-Maximilians University8 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2000年11月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
80
试验地点
8
主要终点
Change in lung functions determined at 0,3,6,12,18,24 months

研究概览

简要总结

The purpose of this randomized, controlled trial was to determine whether a (and if so which) physical conditioning program is effective to improve health status, physical activity, and quality of life in patients with cystic fibrosis. A positive effect of physical conditioning was expected.

详细描述

A high level of physical activity might be beneficial for patients with cystic fibrosis (CF). Several studies have indicated that physical training might improve fitness and lung functions (or, at least, slow the decline in lung functions). However, there are no long-term studies comparing the effects among aerobic training, strength training and no training. Furthermore, motivation to continue a training with little variations between sessions has been shown to decline rapidly. Thus, adherence with such a program may be low. Finally, not all patients feel happy with the same program. Therefore, a home-based individualized sports program might be best suitable to achieve long term benefits. The MUKOTRAIN study is a multicenter randomized controlled trial to determine the effects of a home-based physical training in patients with CF.

Comparisons:

Study A) Patients training aerobically 3 * 30 min per week (supervised in a sports club near their homes) in addition to their baseline physical activity compared to patients training upper and lower body strength 3 * 30 min per week (supervised in a sports club near their homes) compared to patients maintaining their physical activity. The supervised intervention lasted 6 months, thereafter patients were followed for an additional 18 months.

Study B) Patients asked to participate in sport activities at least 3 * 60 min per week (free choice of activities) in addition to their baseline physical activity compared with patients asked to maintain their baseline physical activity.

研究设计

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

入排标准

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

入选标准

  • Clinical diagnosis of cystic fibrosis
  • Able to engage in intense physical activities

排除标准

  • FEV1 <35%predicted
  • Esophageal varicosis
  • Pulmonary bullae
  • Drop in arterial oxygen saturation with exercise <80%
  • Non-CF related chronic diseases
  • Signs of pulmonary hypertension (ECG and echocardiogram)

结局指标

主要结局

Change in lung functions determined at 0,3,6,12,18,24 months

Change in exercise capacity determined at 0,3,6,12,18,24

months

Change in physical activity determined at 0,3,6,12,18,24 months

Change in quality of life determined at 0,3,6,12,18,24 months

次要结局

  • Change in body fatness at 0,3,6,12,18,24 months

研究者

发起方
Julius-Maximilians University
申办方类型
Other

研究点 (8)

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