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Sponsors and Collaborators: |
Julius-Maximilians University Mukoviszidose eV (German CF society) Schweizer CF-Gesellschaft (Swiss CF society) Hannover Medical School Johann Wolfgang Goethe Universität Frankfurt, Germany Stadtspital Triemli, Zurich, Switzerland |
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Information provided by: | Julius-Maximilians University |
ClinicalTrials.gov Identifier: | NCT00231686 |
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.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Behavioral: Supervised aerobic training Behavioral: Supervised strength training Behavioral: Unsupervised training |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study |
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 |
Estimated Enrollment: | 80 |
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.
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.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Children´s Hospital, Julius Maximilians University | |
Wuerzburg, Germany, 97080 | |
Medizinische Hochschule | |
Hannover, Germany, 30625 | |
Johann Wolfgang Goethe Universität | |
Frankfurt, Germany, 60590 | |
Switzerland | |
Stadtspital Triemli | |
Zurich, Switzerland, 8057 |
Principal Investigator: | Helge U Hebestreit, MD | Julius-Maximilians University, Würzburg, Germany |
Principal Investigator: | Susi Kriemler, MD | Stadtspital Triemli, Zürich Switzerland |
Study ID Numbers: | MUKOTRAIN |
Study First Received: | September 30, 2005 |
Last Updated: | September 30, 2005 |
ClinicalTrials.gov Identifier: | NCT00231686 History of Changes |
Health Authority: | Germany: Ethics Commission |
Lung function test Physical conditioning, human Physical fitness Quality of life |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Quality of Life Infant, Newborn, Diseases Pancreatic Diseases |
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |