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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231686
• Other study ID #: MUKOTRAIN
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 30, 2005
• Last updated: September 30, 2005
• Start date: November 2000
• Est. completion date: May 2003

Study information

• Verified date: September 2005
• Source: Julius-Maximilians University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Supervised aerobic training

• Supervised strength training

• Unsupervised training

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe Universität	Frankfurt
Germany	Medizinische Hochschule	Hannover
Germany	Children´s Hospital, Julius Maximilians University	Wuerzburg
Switzerland	Stadtspital Triemli	Zurich

Sponsors (6)

Lead Sponsor	Collaborator
Julius-Maximilians University	Goethe University, Hannover Medical School, Mukoviszidose eV (German CF society), Schweizer CF-Gesellschaft (Swiss CF society), Triemli Hospital

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung functions determined at 0,3,6,12,18,24 months
Primary	Change in exercise capacity determined at 0,3,6,12,18,24
Primary	months
Primary	Change in physical activity determined at 0,3,6,12,18,24 months
Primary	Change in quality of life determined at 0,3,6,12,18,24 months
Secondary	Change in body fatness at 0,3,6,12,18,24 months