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Randomized-controlled Trial of Yoga for Ulcerative Colitis

Primary Purpose

Colitis, Ulcerative

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Yoga
Self-care
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colitis, Ulcerative focused on measuring Colitis, ulcerative, Yoga

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Yoga

Self-care

Arm Description

Outcomes

Primary Outcome Measures

Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ)

Secondary Outcome Measures

Disease-specific quality of life
Inflammatory Bowel Disease Questionnaire (IBDQ)
Generic quality of life
36-Item Short Form Health Survey (SF-36)
Generic quality of life
36-Item Short Form Health Survey (SF-36)
Anxiety/depression
Hospital Anxiety and Depresion Scale (HADS)
Anxiety/depression
Hospital Anxiety and Depresion Scale (HADS)
Subjective stress
Perceived Stress Scale (PSS)
Subjective stress
Perceived Stress Scale (PSS)
Subjective stress
Perceived Stress Questionnaire (PSQ)
Subjective stress
Perceived Stress Questionnaire (PSQ)
Positive/negative affect
Positive and Negative Affect Schedule (PANAS)
Positive/negative affect
Positive and Negative Affect Schedule (PANAS)
Body awareness
Body Awareness Questionnaire (BAQ)
Body awareness
Body Awareness Questionnaire (BAQ)
Body responsiveness
Body Responsiveness Scale (BRS)
Body responsiveness
Body Responsiveness Scale (BRS)
Self-efficacy
General Self-Efficacy Scale
Self-efficacy
General Self-Efficacy Scale
C-reactive protein
C-reactive protein
C-reactive protein
C-reactive protein
Blood sedimentation rate
Blood sedimentation rate
Blood sedimentation rate
Blood sedimentation rate
Faecal calprotectin
Faecal calprotectin
Faecal calprotectin
Faecal calprotectin
Faecal lactoferrin
Faecal lactoferrin
Faecal lactoferrin
Faecal lactoferrin
Faecel PMN-elastase
Faecel PMN-elastase
Faecel PMN-elastase
Faecel PMN-elastase
Disease activity
Clinical Activity Index (CAI-Rachmilewitz)
Disease activity
Clinical Activity Index (CAI-Rachmilewitz)
Salivary cortisol level
Salivary cortisol level - cortisol awakening response
Steroid sensitivity
Steroid sensitivity (IC50)
Andrenergic sensitivity
Andrenergic sensitivity (IC50)
Cholinergic sensitivity
Cholinergic sensitivity (IC50)
Safety
Number of patients with adverse events/serious adverse events
Safety
Number of patients with adverse events/serious adverse events
Hemogram
Hemogram
Hemogram
Hemogram

Full Information

First Posted
January 21, 2014
Last Updated
September 22, 2015
Sponsor
Universität Duisburg-Essen
Collaborators
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
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1. Study Identification

Unique Protocol Identification Number
NCT02043600
Brief Title
Randomized-controlled Trial of Yoga for Ulcerative Colitis
Official Title
Randomized-controlled Trial of Yoga for Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Colitis, ulcerative, Yoga

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Title
Self-care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
12-week Hatha Yoga intervention 90 minutes once a week
Intervention Type
Behavioral
Intervention Name(s)
Self-care
Other Intervention Name(s)
Self-care book
Intervention Description
Self-care books are provided for self-directed use
Primary Outcome Measure Information:
Title
Disease-specific quality of life
Description
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Disease-specific quality of life
Description
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame
6 months
Title
Generic quality of life
Description
36-Item Short Form Health Survey (SF-36)
Time Frame
3 months
Title
Generic quality of life
Description
36-Item Short Form Health Survey (SF-36)
Time Frame
6 months
Title
Anxiety/depression
Description
Hospital Anxiety and Depresion Scale (HADS)
Time Frame
3 months
Title
Anxiety/depression
Description
Hospital Anxiety and Depresion Scale (HADS)
Time Frame
6 months
Title
Subjective stress
Description
Perceived Stress Scale (PSS)
Time Frame
3 months
Title
Subjective stress
Description
Perceived Stress Scale (PSS)
Time Frame
6 months
Title
Subjective stress
Description
Perceived Stress Questionnaire (PSQ)
Time Frame
3 months
Title
Subjective stress
Description
Perceived Stress Questionnaire (PSQ)
Time Frame
6 months
Title
Positive/negative affect
Description
Positive and Negative Affect Schedule (PANAS)
Time Frame
3 months
Title
Positive/negative affect
Description
Positive and Negative Affect Schedule (PANAS)
Time Frame
6 months
Title
Body awareness
Description
Body Awareness Questionnaire (BAQ)
Time Frame
3 months
Title
Body awareness
Description
Body Awareness Questionnaire (BAQ)
Time Frame
6 months
Title
Body responsiveness
Description
Body Responsiveness Scale (BRS)
Time Frame
3 months
Title
Body responsiveness
Description
Body Responsiveness Scale (BRS)
Time Frame
6 months
Title
Self-efficacy
Description
General Self-Efficacy Scale
Time Frame
3 months
Title
Self-efficacy
Description
General Self-Efficacy Scale
Time Frame
6 months
Title
C-reactive protein
Description
C-reactive protein
Time Frame
3 months
Title
C-reactive protein
Description
C-reactive protein
Time Frame
6 months
Title
Blood sedimentation rate
Description
Blood sedimentation rate
Time Frame
3 months
Title
Blood sedimentation rate
Description
Blood sedimentation rate
Time Frame
6 months
Title
Faecal calprotectin
Description
Faecal calprotectin
Time Frame
3 months
Title
Faecal calprotectin
Description
Faecal calprotectin
Time Frame
6 months
Title
Faecal lactoferrin
Description
Faecal lactoferrin
Time Frame
3 months
Title
Faecal lactoferrin
Description
Faecal lactoferrin
Time Frame
6 months
Title
Faecel PMN-elastase
Description
Faecel PMN-elastase
Time Frame
3 months
Title
Faecel PMN-elastase
Description
Faecel PMN-elastase
Time Frame
6 months
Title
Disease activity
Description
Clinical Activity Index (CAI-Rachmilewitz)
Time Frame
3 months
Title
Disease activity
Description
Clinical Activity Index (CAI-Rachmilewitz)
Time Frame
6 months
Title
Salivary cortisol level
Description
Salivary cortisol level - cortisol awakening response
Time Frame
3 months
Title
Steroid sensitivity
Description
Steroid sensitivity (IC50)
Time Frame
3 months
Title
Andrenergic sensitivity
Description
Andrenergic sensitivity (IC50)
Time Frame
3 months
Title
Cholinergic sensitivity
Description
Cholinergic sensitivity (IC50)
Time Frame
3 months
Title
Safety
Description
Number of patients with adverse events/serious adverse events
Time Frame
3 months
Title
Safety
Description
Number of patients with adverse events/serious adverse events
Time Frame
6 months
Title
Hemogram
Description
Hemogram
Time Frame
3 months
Title
Hemogram
Description
Hemogram
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adherence
Description
Intervention adherence (number of sessions attended and home practice diary)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Cramer, PhD
Organizational Affiliation
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jost Langhorst, MD
Organizational Affiliation
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
City
Essen
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
31927346
Citation
Koch 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.
Results Reference
derived
PubMed Identifier
28378342
Citation
Cramer 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.
Results Reference
derived

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Randomized-controlled Trial of Yoga for Ulcerative Colitis

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