NCT00231686

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2000

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

October 4, 2005

Status Verified

September 1, 2005

First QC Date

September 30, 2005

Last Update Submit

September 30, 2005

Conditions

Cystic Fibrosis

Keywords

Lung function testPhysical conditioning, humanPhysical fitnessQuality of life

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (1)

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

Interventions

Supervised aerobic trainingBEHAVIORAL
Supervised strength trainingBEHAVIORAL
Unsupervised trainingBEHAVIORAL

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of cystic fibrosis
  • Able to engage in intense physical activities

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Johann Wolfgang Goethe Universität

Frankfurt, 60590, Germany

Location

Medizinische Hochschule

Hanover, 30625, Germany

Location

Children´s Hospital, Julius Maximilians University

Würzburg, 97080, Germany

Location

Stadtspital Triemli

Zurich, 8057, Switzerland

Location

Related Publications (3)

  • 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.

    PMID: 24571729DERIVED

  • 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.

    PMID: 23588193DERIVED

  • 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.

    PMID: 19643946DERIVED

MeSH Terms

Conditions

Cystic FibrosisMotor Activity

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesBehavior

Study Officials

  • Helge U Hebestreit, MD

    Julius-Maximilians University, Würzburg, Germany

    PRINCIPAL INVESTIGATOR

  • Susi Kriemler, MD

    Stadtspital Triemli, Zürich Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 30, 2005

First Posted

October 4, 2005

Study Start

November 1, 2000

Study Completion

May 1, 2003

Last Updated

October 4, 2005

Record last verified: 2005-09

Locations

DE(3)CH(1)