Quality of Life in Patients With Inflammatory Bowel DiseaseNCT01834573
Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
A study testing physical exercise in people with Quality of Life in Patients With Inflammatory Bowel Disease, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quality of Life in Patients With Inflammatory Bowel Disease
- What is being tested?
- physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years
- proven colitis ulcerosa (CU)
- proven crohns disease (CD)
- diagnosis >= 1 year before start of the study
- low or moderate disease activity
Who cannot join
- < 18 years
- high disease activity
- regular exercise > 2 hours per week
- diagnosis of CU oder CD < 1 year before start of the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- physical exercise
- Keywords
- inflammatory bowel disease, IBD, quality of life, Inflammatory Bowel Disease Questionnaire
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical exerciseBehavioural
10 weeks physical exercise; three times a week
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Patients of the intervention arm receive a 10 week exercise program Receives: Behavioral: physical exercise |
| Control | No intervention | Patients of the control arm do not participate in exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: 10 weeks
Secondary outcomes (1)
disease activity
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life in Patients With Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Klare, MD, Principal investigator, II. Medizinische Klinik, Klinikum rechts der Isar München, GermanyWolfgang Huber, MD, Study director, II Medizinische Klinik, Klinikum rechts der Isar München, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834573
- Sponsor's protocol ID
- runIBD
- Status last verified
- Dec 2013
- First submitted
- 14 Apr 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Exercise on Quality of Life in Patients With Inflammatory Bowel Disease - a Pilot Study.
- ClinicalTrials.gov ID
- NCT01834573
- Acronym / sponsor ID
- runIBD
- Keywords
- inflammatory bowel disease, IBD, quality of life, Inflammatory Bowel Disease Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: physical exercisePatients of the intervention arm receive a 10 week exercise program |
| Control | No intervention | –Patients of the control arm do not participate in exercise |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >18 years
- proven colitis ulcerosa (CU)
- proven crohns disease (CD)
- diagnosis >= 1 year before start of the study
- low or moderate disease activity
Key exclusion criteria (4 listed)
- < 18 years
- high disease activity
- regular exercise > 2 hours per week
- diagnosis of CU oder CD < 1 year before start of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical exercise10 weeks physical exercise; three times a week | Behavioural | Intervention |
Primary outcome
Quality of life
Time frame: 10 weeks
1 secondary outcome
disease activity
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Klare, MD principal investigator
II. Medizinische Klinik, Klinikum rechts der Isar München, Germany
Wolfgang Huber, MD study director
II Medizinische Klinik, Klinikum rechts der Isar München, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical exercise in people with Quality of Life in Patients With Inflammatory Bowel Disease, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2013.