Randomized-controlled Trial of Yoga for Ulcerative Colitis

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: Completed
• Conditions: Colitis, Ulcerative
• Intervention / Treatment: Behavioral: Yoga; Behavioral: Self-care

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBDQ)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBDQ)	6 months
Generic quality of life	36-Item Short Form Health Survey (SF-36)	3 months
Generic quality of life	36-Item Short Form Health Survey (SF-36)	6 months
Anxiety/depression	Hospital Anxiety and Depresion Scale (HADS)	3 months
Anxiety/depression	Hospital Anxiety and Depresion Scale (HADS)	6 months
Subjective stress	Perceived Stress Scale (PSS)	3 months
Subjective stress	Perceived Stress Scale (PSS)	6 months
Subjective stress	Perceived Stress Questionnaire (PSQ)	3 months
Subjective stress	Perceived Stress Questionnaire (PSQ)	6 months
Positive/negative affect	Positive and Negative Affect Schedule (PANAS)	3 months
Positive/negative affect	Positive and Negative Affect Schedule (PANAS)	6 months
Body awareness	Body Awareness Questionnaire (BAQ)	3 months
Body awareness	Body Awareness Questionnaire (BAQ)	6 months
Body responsiveness	Body Responsiveness Scale (BRS)	3 months
Body responsiveness	Body Responsiveness Scale (BRS)	6 months
Self-efficacy	General Self-Efficacy Scale	3 months
Self-efficacy	General Self-Efficacy Scale	6 months
C-reactive protein	C-reactive protein	3 months
C-reactive protein	C-reactive protein	6 months
Blood sedimentation rate	Blood sedimentation rate	3 months
Blood sedimentation rate	Blood sedimentation rate	6 months
Faecal calprotectin	Faecal calprotectin	3 months
Faecal calprotectin	Faecal calprotectin	6 months
Faecal lactoferrin	Faecal lactoferrin	3 months
Faecal lactoferrin	Faecal lactoferrin	6 months
Faecel PMN-elastase	Faecel PMN-elastase	3 months
Faecel PMN-elastase	Faecel PMN-elastase	6 months
Disease activity	Clinical Activity Index (CAI-Rachmilewitz)	3 months
Disease activity	Clinical Activity Index (CAI-Rachmilewitz)	6 months
Salivary cortisol level	Salivary cortisol level - cortisol awakening response	3 months
Steroid sensitivity	Steroid sensitivity (IC50)	3 months
Andrenergic sensitivity	Andrenergic sensitivity (IC50)	3 months
Cholinergic sensitivity	Cholinergic sensitivity (IC50)	3 months
Safety	Number of patients with adverse events/serious adverse events	3 months
Safety	Number of patients with adverse events/serious adverse events	6 months
Hemogram	Hemogram	3 months
Hemogram	Hemogram	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Intervention adherence (number of sessions attended and home practice diary)	3 months

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Collaborators: Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
• Investigators: 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

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (ESTIMATE): January 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Yoga; Colitis, ulcerative
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 13-5560-BO