Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis
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|ClinicalTrials.gov Identifier: NCT00231686|
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : October 4, 2005
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Behavioral: Supervised aerobic training Behavioral: Supervised strength training Behavioral: Unsupervised training||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2000|
|Study Completion Date :||May 2003|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|