Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Technische Universität München
ClinicalTrials.gov Identifier:
NCT01834573
First received: April 14, 2013
Last updated: December 22, 2013
Last verified: December 2013

April 14, 2013
December 22, 2013
April 2013
September 2013   (final data collection date for primary outcome measure)
Quality of life [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01834573 on ClinicalTrials.gov Archive Site
disease activity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.

Patients with inflammatory bowel disease (IBD) suffer from a diminished quality of life compared to healthy adults. This is due to the chronic course of disease accompanied with diarrhea, stomach pains but also with psychological stress.

It is known that physical education may improve course of disease and quality of life in a multitude of diseases. These include coronary heart disease, malignancies and also depression. The investigators believe that sport is as effective supportive tool in improving quality of life in IBD patients. But data is lacking with regard to controlled randomized clinical trials. Because of the small amount of data available the investigators considered a feasibility study. Our hypothesis is that IBD patients will cope with moderate exercise. The investigators further suspect that these patients improve their quality of life compared with patients in the control group.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Quality of Life in Patients With Inflammatory Bowel Disease
Behavioral: physical exercise
10 weeks physical exercise; three times a week
  • Active Comparator: Intervention
    Patients of the intervention arm receive a 10 week exercise program
    Intervention: Behavioral: physical exercise
  • No Intervention: Control
    Patients of the control arm do not participate in exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • >18 years
  • proven colitis ulcerosa (CU)
  • proven crohns disease (CD)
  • diagnosis >= 1 year before start of the study
  • low or moderate disease activity

Exclusion Criteria:

  • < 18 years
  • high disease activity
  • regular exercise > 2 hours per week
  • diagnosis of CU oder CD < 1 year before start of the study
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01834573
runIBD
No
Technische Universität München
Technische Universität München
Not Provided
Principal Investigator: Peter Klare, MD II. Medizinische Klinik, Klinikum rechts der Isar München, Germany
Study Director: Wolfgang Huber, MD II Medizinische Klinik, Klinikum rechts der Isar München, Germany
Technische Universität München
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP