NCT Number: NCT00231686
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
12 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2 / Phase 3
Primary location
Johann Wolfgang Goethe Universität, Frankfurt, Germany
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Clinical diagnosis of cystic fibrosis
- Able to engage in intense physical activities
Exclusion criteria
- 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)
Treatment and study plan
Supervised strength training
BehavioralUnsupervised training
BehavioralPrimary outcomes
-
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
Secondary outcomes
-
Change in body fatness at 0,3,6,12,18,24 months
Sponsors and collaborators
Lead sponsor
Julius-Maximilians University
Other
Collaborators
- Goethe University
- Hannover Medical School
- Mukoviszidose eV (German CF society)
- Schweizer CF-Gesellschaft (Swiss CF society)
- Triemli Hospital
Registry information
Official study title
Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN
Important dates
- Study start
- 2000
- Study completion
- 2003
- First posted
- Oct 4, 2005
- Registry last updated
- Oct 4, 2005
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Increase Tolerance for Exercise and Raise Activity Through Connectedness Trial
NCT02700243
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
View Trial DetailsExtrapulmonary Effects of Cystic Fibrosis on Physical Activity of Adult Patients.
NCT01848392
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Paris, France
View Trial DetailsEffects of Telerehabilitation-based Exercises in Cystic Fibrosis
NCT05590169
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Istanbul, Turkey (Türkiye)
View Trial DetailsThe Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis
NCT05147285
Behavior, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Ankara, Turkey (Türkiye)
View Trial Details