Inflammatory Bowel DiseaseNCT02222584
The Effects of Physical Activity on Patients With Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Physical activity (PA) is beneficial in the prevention and management of chronic disease. However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and whether or not vigorous PA may have beneficial effects on patients' health. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 158 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2014to Feb 2018
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to Feburary 2015
Who may be able to join
- Age ≥ 19
- patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis, intestinal behcet's disease)
Who cannot join
- Age <19
- Patient who denied to response the survey questions
- Patient who denied to enroll the survey research
Trial locations and contacts
1 site in 1 country.
About this study
Physical activity (PA) is beneficial in the prevention and management of chronic disease. However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the effect of PA on quality of life of patients with IBD.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- inflammatory bowel disease, physical activity, disease activity, quality of life
- Medical subject headings
- Inflammatory Bowel Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBD group | patients with with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to February 2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of physical activity (PA)
Physical activity (PA) levels were assessed using the International PA Questionnaire. Based on self-reported frequency (day) and duration (hr) of physical activities, corresponding metabolic equivalent (MET-hr/wk) values were calculated to lowest PA, low PA, moderate PA and highest PA
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222584
- Sponsor's protocol ID
- 4-2014-0364
- Status last verified
- Dec 2018
- First submitted
- 19 Aug 2014
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Physical Activity on Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02222584
- Acronym / sponsor ID
- 4-2014-0364
- Conditions
- Inflammatory Bowel Disease
- Keywords
- inflammatory bowel disease, physical activity, disease activity, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 21 Aug 2014 (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.
Physical activity (PA) is beneficial in the prevention and management of chronic disease. However, few data exist regarding the level of PA in inflammatory bowel disease (IBD) and whether or not vigorous PA may have beneficial effects on patients' health. To evaluate the level of PA and the effect of PA on disease activity of patients with IBD. To evaluate the effect of PA on quality of life of patients with IBD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD group | – | –patients with with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to February 2015 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with inflammatory bowel disease who are visiting the out-patient clinic of severance hospital from July 2014 to Feburary 2015
Key inclusion criteria (2 listed)
- Age ≥ 19
- patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis, intestinal behcet's disease)
Key exclusion criteria (3 listed)
- Age <19
- Patient who denied to response the survey questions
- Patient who denied to enroll the survey research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
level of physical activity (PA)
Time frame: 1 hour
Physical activity (PA) levels were assessed using the International PA Questionnaire. Based on self-reported frequency (day) and duration (hr) of physical activities, corresponding metabolic equivalent (MET-hr/wk) values were calculated to lowest PA, low PA, moderate PA and highest PA
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 27 Mar 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 3 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 27 Mar 2019. 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 South Korea. 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?
level of physical activity (PA) (time frame: 1 hour). 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 27 Mar 2019.