Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
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.
Behavioral: Supervised aerobic training
Behavioral: Supervised strength training
Behavioral: Unsupervised training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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
- 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
- Change in body fatness at 0,3,6,12,18,24 months
|Study Start Date:||November 2000|
|Estimated Study Completion Date:||May 2003|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231686
|Johann Wolfgang Goethe Universität|
|Frankfurt, Germany, 60590|
|Hannover, Germany, 30625|
|Children´s Hospital, Julius Maximilians University|
|Wuerzburg, Germany, 97080|
|Zurich, Switzerland, 8057|
|Principal Investigator:||Helge U Hebestreit, MD||Julius-Maximilians University, Würzburg, Germany|
|Principal Investigator:||Susi Kriemler, MD||Stadtspital Triemli, Zürich Switzerland|