Cystic Fibrosis Clinical Trial
Official title:
Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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