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

NCT ID: NCT01834573

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Life in Patients With Inflammatory Bowel Disease

Keywords

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inflammatory bowel disease IBD quality of life Inflammatory Bowel Disease Questionnaire

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Patients of the intervention arm receive a 10 week exercise program

Group Type ACTIVE_COMPARATOR

physical exercise

Intervention Type BEHAVIORAL

10 weeks physical exercise; three times a week

Control

Patients of the control arm do not participate in exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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physical exercise

10 weeks physical exercise; three times a week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Klare, MD

Role: PRINCIPAL_INVESTIGATOR

II. Medizinische Klinik, Klinikum rechts der Isar München, Germany

Wolfgang Huber, MD

Role: STUDY_DIRECTOR

II Medizinische Klinik, Klinikum rechts der Isar München, Germany

Locations

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Klinikum rechts der Isar

München, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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runIBD

Identifier Type: -

Identifier Source: org_study_id