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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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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 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. |
- Quality of life [ Time Frame: 10 weeks ]
- disease activity [ Time Frame: 10 weeks ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01834573
| Germany | |
| Klinikum rechts der Isar | |
| München, Bayern, Germany, 81675 | |
| 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
| 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017