Randomized-controlled Trial of Yoga for Ulcerative Colitis

September 22, 2015 updated by: Holger Cramer, Universität Duisburg-Essen
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45276
        • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Yoga
Behavioral: Yoga
12-week Hatha Yoga intervention 90 minutes once a week
ACTIVE_COMPARATOR: Self-care
Behavioral: Self-care
Self-care books are provided for self-directed use
Other Names:
  • Self-care book

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Disease-specific quality of life
Time Frame: 3 months
Inflammatory Bowel Disease Questionnaire (IBDQ)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease-specific quality of life
Time Frame: 6 months
Inflammatory Bowel Disease Questionnaire (IBDQ)
6 months
Generic quality of life
Time Frame: 3 months
36-Item Short Form Health Survey (SF-36)
3 months
Generic quality of life
Time Frame: 6 months
36-Item Short Form Health Survey (SF-36)
6 months
Anxiety/depression
Time Frame: 3 months
Hospital Anxiety and Depresion Scale (HADS)
3 months
Anxiety/depression
Time Frame: 6 months
Hospital Anxiety and Depresion Scale (HADS)
6 months
Subjective stress
Time Frame: 3 months
Perceived Stress Scale (PSS)
3 months
Subjective stress
Time Frame: 6 months
Perceived Stress Scale (PSS)
6 months
Subjective stress
Time Frame: 3 months
Perceived Stress Questionnaire (PSQ)
3 months
Subjective stress
Time Frame: 6 months
Perceived Stress Questionnaire (PSQ)
6 months
Positive/negative affect
Time Frame: 3 months
Positive and Negative Affect Schedule (PANAS)
3 months
Positive/negative affect
Time Frame: 6 months
Positive and Negative Affect Schedule (PANAS)
6 months
Body awareness
Time Frame: 3 months
Body Awareness Questionnaire (BAQ)
3 months
Body awareness
Time Frame: 6 months
Body Awareness Questionnaire (BAQ)
6 months
Body responsiveness
Time Frame: 3 months
Body Responsiveness Scale (BRS)
3 months
Body responsiveness
Time Frame: 6 months
Body Responsiveness Scale (BRS)
6 months
Self-efficacy
Time Frame: 3 months
General Self-Efficacy Scale
3 months
Self-efficacy
Time Frame: 6 months
General Self-Efficacy Scale
6 months
C-reactive protein
Time Frame: 3 months
C-reactive protein
3 months
C-reactive protein
Time Frame: 6 months
C-reactive protein
6 months
Blood sedimentation rate
Time Frame: 3 months
Blood sedimentation rate
3 months
Blood sedimentation rate
Time Frame: 6 months
Blood sedimentation rate
6 months
Faecal calprotectin
Time Frame: 3 months
Faecal calprotectin
3 months
Faecal calprotectin
Time Frame: 6 months
Faecal calprotectin
6 months
Faecal lactoferrin
Time Frame: 3 months
Faecal lactoferrin
3 months
Faecal lactoferrin
Time Frame: 6 months
Faecal lactoferrin
6 months
Faecel PMN-elastase
Time Frame: 3 months
Faecel PMN-elastase
3 months
Faecel PMN-elastase
Time Frame: 6 months
Faecel PMN-elastase
6 months
Disease activity
Time Frame: 3 months
Clinical Activity Index (CAI-Rachmilewitz)
3 months
Disease activity
Time Frame: 6 months
Clinical Activity Index (CAI-Rachmilewitz)
6 months
Salivary cortisol level
Time Frame: 3 months
Salivary cortisol level - cortisol awakening response
3 months
Steroid sensitivity
Time Frame: 3 months
Steroid sensitivity (IC50)
3 months
Andrenergic sensitivity
Time Frame: 3 months
Andrenergic sensitivity (IC50)
3 months
Cholinergic sensitivity
Time Frame: 3 months
Cholinergic sensitivity (IC50)
3 months
Safety
Time Frame: 3 months
Number of patients with adverse events/serious adverse events
3 months
Safety
Time Frame: 6 months
Number of patients with adverse events/serious adverse events
6 months
Hemogram
Time Frame: 3 months
Hemogram
3 months
Hemogram
Time Frame: 6 months
Hemogram
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 3 months
Intervention adherence (number of sessions attended and home practice diary)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universität Duisburg-Essen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Holger Cramer, PhD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
  • Study Director: Jost Langhorst, MD, Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 13-5560-BO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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