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

NCT01834573 | Completed

• 1 other identifier: runIBD
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life in Patients With Inflammatory Bowel Disease

Keywords

inflammatory bowel disease; IBD; quality of life; Inflammatory Bowel Disease Questionnaire

Outcome Measures

Primary Outcomes (1)

• Quality of life

  10 weeks

Secondary Outcomes (1)

• disease activity

  10 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients of the intervention arm receive a 10 week exercise program

Behavioral: physical exercise

Control

NO INTERVENTION

Patients of the control arm do not participate in exercise

Interventions

physical exercise BEHAVIORAL

10 weeks physical exercise; three times a week

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• proven colitis ulcerosa (CU)
• proven crohns disease (CD)
• diagnosis \>= 1 year before start of the study
• low or moderate disease activity

You may not qualify if:

• \< 18 years
• high disease activity
• regular exercise \> 2 hours per week
• diagnosis of CU oder CD \< 1 year before start of the study

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar

München, Bavaria, 81675, Germany

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Peter Klare, MD

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

  PRINCIPAL INVESTIGATOR

• Wolfgang Huber, MD

  II Medizinische Klinik, Klinikum rechts der Isar München, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 24, 2013

Record last verified: 2013-12

Locations

DE (1)