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

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ClinicalTrials.gov Identifier: NCT01834573
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : December 24, 2013
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Quality of Life in Patients With Inflammatory Bowel Disease Behavioral: physical exercise Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Study Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : November 2013

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. disease activity [ Time Frame: 10 weeks ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01834573     History of Changes
Other Study ID Numbers: runIBD
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: December 24, 2013
Last Verified: December 2013

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

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