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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Behavioral: Supervised aerobic training; Behavioral: Supervised strength training; Behavioral: Unsupervised training

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 Type: Interventional
• Enrollment: 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, 60590
    • Johann Wolfgang Goethe Universität
  • Hannover, Germany, 30625
    • Medizinische Hochschule
  • Wuerzburg, Germany, 97080
    • Children´s Hospital, Julius Maximilians University
• Switzerland
  • Zurich, Switzerland, 8057
    • Stadtspital Triemli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Change in body fatness at 0,3,6,12,18,24 months

Collaborators and Investigators

• Sponsor: Julius-Maximilians University
• Collaborators: Hannover Medical School; Goethe University; Triemli Hospital; Mukoviszidose eV (German CF society); Schweizer CF-Gesellschaft (Swiss CF society)
• Investigators: Principal Investigator: Helge U Hebestreit, MD, Julius-Maximilians University, Würzburg, Germany; Principal Investigator: Susi Kriemler, MD, Stadtspital Triemli, Zürich Switzerland

Publications and helpful links

General Publications

• Hebestreit H, Schmid K, Kieser S, Junge S, Ballmann M, Roth K, Hebestreit A, Schenk T, Schindler C, Posselt HG, Kriemler S. Quality of life is associated with physical activity and fitness in cystic fibrosis. BMC Pulm Med. 2014 Feb 27;14:26. doi: 10.1186/1471-2466-14-26.
• Kriemler S, Kieser S, Junge S, Ballmann M, Hebestreit A, Schindler C, Stussi C, Hebestreit H. Effect of supervised training on FEV1 in cystic fibrosis: a randomised controlled trial. J Cyst Fibros. 2013 Dec;12(6):714-20. doi: 10.1016/j.jcf.2013.03.003. Epub 2013 Apr 13.
• Hebestreit H, Kieser S, Junge S, Ballmann M, Hebestreit A, Schindler C, Schenk T, Posselt HG, Kriemler S. Long-term effects of a partially supervised conditioning programme in cystic fibrosis. Eur Respir J. 2010 Mar;35(3):578-83. doi: 10.1183/09031936.00062409. Epub 2009 Jul 30.

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Study Completion: May 1, 2003

Study Registration Dates

• First Submitted: September 30, 2005
• First Submitted That Met QC Criteria: September 30, 2005
• First Posted (Estimate): October 4, 2005

Study Record Updates

• Last Update Posted (Estimate): October 4, 2005
• Last Update Submitted That Met QC Criteria: September 30, 2005
• Last Verified: September 1, 2005

More Information

Terms related to this study

• Keywords: Quality of life; Physical fitness; Lung function test; Physical conditioning, human
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: MUKOTRAIN