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

Primary Purpose

Quality of Life in Patients With Inflammatory Bowel Disease

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
physical exercise
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life in Patients With Inflammatory Bowel Disease focused on measuring inflammatory bowel disease, IBD, quality of life, Inflammatory Bowel Disease Questionnaire

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum rechts der Isar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention

Control

Arm Description

Patients of the intervention arm receive a 10 week exercise program

Patients of the control arm do not participate in exercise

Outcomes

Primary Outcome Measures

Quality of life

Secondary Outcome Measures

disease activity

Full Information

First Posted
April 14, 2013
Last Updated
December 22, 2013
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01834573
Brief Title
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Official Title
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life in Patients With Inflammatory Bowel Disease
Keywords
inflammatory bowel disease, IBD, quality of life, Inflammatory Bowel Disease Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Patients of the intervention arm receive a 10 week exercise program
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients of the control arm do not participate in exercise
Intervention Type
Behavioral
Intervention Name(s)
physical exercise
Intervention Description
10 weeks physical exercise; three times a week
Primary Outcome Measure Information:
Title
Quality of life
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
disease activity
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
Organizational Affiliation
II. Medizinische Klinik, Klinikum rechts der Isar München, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wolfgang Huber, MD
Organizational Affiliation
II Medizinische Klinik, Klinikum rechts der Isar München, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum rechts der Isar
City
München
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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