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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00231686

Enrollment

Registered

2005-10-04

Start date

2000-11-30

Completion date

2003-05-31

Last updated

2005-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Lung function test, Physical conditioning, human, Physical fitness, Quality of life

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.

Interventions

BEHAVIORALSupervised aerobic training

BEHAVIORALSupervised strength training

BEHAVIORALUnsupervised training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Measure	Time frame
Change in body fatness at 0,3,6,12,18,24 months	—

Countries

Germany, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026