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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01834573

First Posted: April 18, 2013

Last Update Posted: December 24, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Technische Universität München

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: 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.

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Health Checkup

U.S. FDA Resources

Further study details as provided by Technische Universität München:

Primary Outcome Measures:

Quality of life [ Time Frame: 10 weeks ]

Secondary Outcome Measures:

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

Information from the National Library of Medicine

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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

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


Responsible Party:	Technische Universität München
ClinicalTrials.gov Identifier:	NCT01834573 History of Changes
Other Study ID Numbers:	runIBD
First Submitted:	April 14, 2013
First Posted:	April 18, 2013
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

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