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

Phase 2

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT00231686
• Lead Sponsor: Julius-Maximilians University

Brief Summary

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.

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.

Study Timeline

• Study Start: 2000-11
• Study Completion: 2003-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Last Update Submitted: 2005-09-30
• Study First Posted: 2005-10-04
• Last Update Posted: 2005-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in body fatness at 0,3,6,12,18,24 months

Trial Locations

Locations (4)

Medizinische Hochschule; 🇩🇪 Hannover, Germany

Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt, Germany

Stadtspital Triemli; 🇨🇭 Zurich, Switzerland

Children´s Hospital, Julius Maximilians University; 🇩🇪 Wuerzburg, Germany