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Completed

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.

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Key information

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

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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 aerobic training

Behavioral

Supervised strength training

Behavioral

Unsupervised training

Behavioral

Primary outcomes

  1. Change in lung functions determined at 0,3,6,12,18,24 months

  2. Change in exercise capacity determined at 0,3,6,12,18,24

  3. months

  4. Change in physical activity determined at 0,3,6,12,18,24 months

  5. Change in quality of life determined at 0,3,6,12,18,24 months

Secondary outcomes

  1. 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.

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