Effects of a 6-Months Physical Conditioning Program in Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
Mukoviszidose eV (German CF society)
Schweizer CF-Gesellschaft (Swiss CF society)
Hannover Medical School
Goethe University
Triemli Hospital
Information provided by:
Julius-Maximilians University
ClinicalTrials.gov Identifier:
NCT00231686
First received: September 30, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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
Cystic Fibrosis
Behavioral: Supervised aerobic training
Behavioral: Supervised strength training
Behavioral: Unsupervised training
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Julius-Maximilians University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Change in body fatness at 0,3,6,12,18,24 months

Estimated Enrollment: 80
Study Start Date: November 2000
Estimated Study Completion Date: May 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231686

Locations
Germany
Johann Wolfgang Goethe Universität
Frankfurt, Germany, 60590
Medizinische Hochschule
Hannover, Germany, 30625
Children´s Hospital, Julius Maximilians University
Wuerzburg, Germany, 97080
Switzerland
Stadtspital Triemli
Zurich, Switzerland, 8057
Sponsors and Collaborators
Julius-Maximilians University
Mukoviszidose eV (German CF society)
Schweizer CF-Gesellschaft (Swiss CF society)
Hannover Medical School
Goethe University
Triemli Hospital
Investigators
Principal Investigator: Helge U Hebestreit, MD Julius-Maximilians University, Würzburg, Germany
Principal Investigator: Susi Kriemler, MD Stadtspital Triemli, Zürich Switzerland
  More Information

No publications provided by Julius-Maximilians University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00231686     History of Changes
Other Study ID Numbers: MUKOTRAIN
Study First Received: September 30, 2005
Last Updated: September 30, 2005
Health Authority: Germany: Ethics Commission

Keywords provided by Julius-Maximilians University:
Lung function test
Physical conditioning, human
Physical fitness
Quality of life

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 20, 2014