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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
History of Changes
  Purpose

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.


Condition Intervention
Quality of Life in Patients With Inflammatory Bowel Disease
 Behavioral: physical exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Quality of life [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease activity [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Enrollment: 36
Study Start Date: April 2013
Study Completion Date: November 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention
Patients of the intervention arm receive a 10 week exercise program
 Behavioral: physical exercise
10 weeks physical exercise; three times a week
No Intervention: Control
Patients of the control arm do not participate in exercise

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834573

Locations
Germany
Klinikum rechts der Isar
München, Bayern, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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
  More Information

No publications provided

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01834573     History of Changes
Other Study ID Numbers: runIBD
Study First Received: April 14, 2013
Last Updated: December 22, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität München:
inflammatory bowel disease
IBD
quality of life
Inflammatory Bowel Disease Questionnaire

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on February 27, 2015