Colitis, UlcerativeNCT02043600
Randomized-controlled Trial of Yoga for Ulcerative Colitis
A study testing Yoga and Self-care in people with Colitis, Ulcerative, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Yoga and Self-care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Aug 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ulcerative colitis (clinical, endoscopic and histological diagnosis)
- Disease duration at least 12 months
- Clinical remission for at least 4 weeks and less than 12 months
- CAI < 5
- IBDQ < 170
- Physical and mental ability to perform yoga
- No regular practice of yoga or Pilates in the previous 12 months
Who cannot join
- Clinically active disease (CAI > 4 Rachmilewitz)
- Complete resection of the colon
- Acute, infectious or chronic active ulcerative colitis
- Severe disease precluding yoga practice
- Malignancy with a disease-free survival < 5 years except curatively treated basalioma of the skin
- Alcohol or drug abuse
- Dementia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, 45276
About this study
The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis.
- Conditions
- Colitis, Ulcerative
- Being tested
- Yoga, Self-care
- Keywords
- Colitis, ulcerative, Yoga
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
12-week Hatha Yoga intervention 90 minutes once a week
Self-careBehavioural
Also called Self-care book
Self-care books are provided for self-directed use
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Not described Receives: Behavioral: Yoga |
| Self-care | Active comparator | Not described Receives: Behavioral: Self-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 3 months
Secondary outcomes (37)
Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: 6 months
Generic quality of life
36-Item Short Form Health Survey (SF-36)
Measured: 3 months
Generic quality of life
36-Item Short Form Health Survey (SF-36)
Measured: 6 months
Anxiety/depression
Hospital Anxiety and Depresion Scale (HADS)
Measured: 3 months
Anxiety/depression
Hospital Anxiety and Depresion Scale (HADS)
Measured: 6 months
Subjective stress
Perceived Stress Scale (PSS)
Measured: 3 months
Subjective stress
Perceived Stress Scale (PSS)
Measured: 6 months
Subjective stress
Perceived Stress Questionnaire (PSQ)
Measured: 3 months
Subjective stress
Perceived Stress Questionnaire (PSQ)
Measured: 6 months
Positive/negative affect
Positive and Negative Affect Schedule (PANAS)
Measured: 3 months
Positive/negative affect
Positive and Negative Affect Schedule (PANAS)
Measured: 6 months
Body awareness
Body Awareness Questionnaire (BAQ)
Measured: 3 months
Body awareness
Body Awareness Questionnaire (BAQ)
Measured: 6 months
Body responsiveness
Body Responsiveness Scale (BRS)
Measured: 3 months
Body responsiveness
Body Responsiveness Scale (BRS)
Measured: 6 months
Self-efficacy
General Self-Efficacy Scale
Measured: 3 months
Self-efficacy
General Self-Efficacy Scale
Measured: 6 months
C-reactive protein
C-reactive protein
Measured: 3 months
C-reactive protein
C-reactive protein
Measured: 6 months
Blood sedimentation rate
Blood sedimentation rate
Measured: 3 months
Blood sedimentation rate
Blood sedimentation rate
Measured: 6 months
Faecal calprotectin
Faecal calprotectin
Measured: 3 months
Faecal calprotectin
Faecal calprotectin
Measured: 6 months
Faecal lactoferrin
Faecal lactoferrin
Measured: 3 months
Faecal lactoferrin
Faecal lactoferrin
Measured: 6 months
Faecel PMN-elastase
Faecel PMN-elastase
Measured: 3 months
Faecel PMN-elastase
Faecel PMN-elastase
Measured: 6 months
Disease activity
Clinical Activity Index (CAI-Rachmilewitz)
Measured: 3 months
Disease activity
Clinical Activity Index (CAI-Rachmilewitz)
Measured: 6 months
Salivary cortisol level
Salivary cortisol level - cortisol awakening response
Measured: 3 months
Steroid sensitivity
Steroid sensitivity (IC50)
Measured: 3 months
Andrenergic sensitivity
Andrenergic sensitivity (IC50)
Measured: 3 months
Cholinergic sensitivity
Cholinergic sensitivity (IC50)
Measured: 3 months
Safety
Number of patients with adverse events/serious adverse events
Measured: 3 months
Safety
Number of patients with adverse events/serious adverse events
Measured: 6 months
Hemogram
Hemogram
Measured: 3 months
Hemogram
Hemogram
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
- Investigators
- Holger Cramer, PhD, Principal investigator, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, GermanyJost Langhorst, MD, Study director, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043600
- Sponsor's protocol ID
- 13-5560-BO
- Status last verified
- Sep 2015
- First submitted
- 21 Jan 2014
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Koch AK, Schols M, Langhorst J, Dobos G, Cramer H. Perceived stress mediates the effect of yoga on quality of life and disease activity in ulcerative colitis. Secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Mar;130:109917. doi: 10.1016/j.jpsychores.2019.109917. Epub 2019 Dec 31.
PubMed 31927346Cramer H, Schafer M, Schols M, Kocke J, Elsenbruch S, Lauche R, Engler H, Dobos G, Langhorst J. Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis. Aliment Pharmacol Ther. 2017 Jun;45(11):1379-1389. doi: 10.1111/apt.14062. Epub 2017 Apr 5.
PubMed 28378342
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial of Yoga for Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02043600
- Acronym / sponsor ID
- 13-5560-BO
- Conditions
- Colitis, Ulcerative
- Keywords
- Colitis, ulcerative, Yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 23 Jan 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.
The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga |
| Self-care | Active comparator | Behavioral: Self-care |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ulcerative colitis (clinical, endoscopic and histological diagnosis)
- Disease duration at least 12 months
- Clinical remission for at least 4 weeks and less than 12 months
- CAI < 5
- IBDQ < 170
Key exclusion criteria (8 listed)
- Clinically active disease (CAI > 4 Rachmilewitz)
- Complete resection of the colon
- Acute, infectious or chronic active ulcerative colitis
- Severe disease precluding yoga practice
- Malignancy with a disease-free survival < 5 years except curatively treated basalioma of the skin
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 |
|---|---|---|
| Yoga12-week Hatha Yoga intervention 90 minutes once a week | Behavioural | Yoga |
| Self-careAlso: Self-care bookSelf-care books are provided for self-directed use | Behavioural | Self-care |
Primary outcome
Disease-specific quality of life
Time frame: 3 months
Inflammatory Bowel Disease Questionnaire (IBDQ)
37 secondary outcomes
Disease-specific quality of life
Time frame: 6 months
Generic quality of life
Time frame: 3 months
Generic quality of life
Time frame: 6 months
Anxiety/depression
Time frame: 3 months
Anxiety/depression
Time frame: 6 months
Subjective stress
Time frame: 3 months
Subjective stress
Time frame: 6 months
Subjective stress
Time frame: 3 months
Subjective stress
Time frame: 6 months
Positive/negative affect
Time frame: 3 months
Positive/negative affect
Time frame: 6 months
Body awareness
Time frame: 3 months
Body awareness
Time frame: 6 months
Body responsiveness
Time frame: 3 months
Body responsiveness
Time frame: 6 months
Self-efficacy
Time frame: 3 months
Self-efficacy
Time frame: 6 months
C-reactive protein
Time frame: 3 months
C-reactive protein
Time frame: 6 months
Blood sedimentation rate
Time frame: 3 months
Blood sedimentation rate
Time frame: 6 months
Faecal calprotectin
Time frame: 3 months
Faecal calprotectin
Time frame: 6 months
Faecal lactoferrin
Time frame: 3 months
Faecal lactoferrin
Time frame: 6 months
Faecel PMN-elastase
Time frame: 3 months
Faecel PMN-elastase
Time frame: 6 months
Disease activity
Time frame: 3 months
Disease activity
Time frame: 6 months
Salivary cortisol level
Time frame: 3 months
Steroid sensitivity
Time frame: 3 months
Andrenergic sensitivity
Time frame: 3 months
Cholinergic sensitivity
Time frame: 3 months
Safety
Time frame: 3 months
Safety
Time frame: 6 months
Hemogram
Time frame: 3 months
Hemogram
Time frame: 6 months
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 23 Sep 2015.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 31927346Koch AK, Schols M, Langhorst J, Dobos G, Cramer H. Perceived stress mediates the effect of yoga on quality of life and disease activity in ulcerative colitis. Secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Mar;130:109917. doi: 10.1016/j.jpsychores.2019.109917. Epub 2019 Dec 31.
- Derived from this study: PubMed 28378342Cramer H, Schafer M, Schols M, Kocke J, Elsenbruch S, Lauche R, Engler H, Dobos G, Langhorst J. Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis. Aliment Pharmacol Ther. 2017 Jun;45(11):1379-1389. doi: 10.1111/apt.14062. Epub 2017 Apr 5.
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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.
Holger Cramer, PhD principal investigator
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
Jost Langhorst, MD study director
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, 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 Yoga and Self-care in people with Colitis, Ulcerative, run by Universität Duisburg-Essen 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 7 inclusion and 8 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 23 Sep 2015. 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?
Disease-specific quality of life (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043600, which also lists 3 linked publications.
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 23 Sep 2015.