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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a 6-Months Physical Conditioning Program on Health Status and Physical Activity in Youths and Young Adults With Cystic Fibrosis - MUKOTRAIN

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Supervised aerobic training
* Behavioral: Supervised strength training
* Behavioral: Unsupervised training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Supervised aerobic training|nan|
|Behavioral: Supervised strength training|nan|
|Behavioral: Unsupervised training|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body fatness at 0,3,6,12,18,24 months |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung function test, Physical conditioning, human, Physical fitness, Quality of life