Randomized-controlled Trial of Yoga for Ulcerative Colitis

Colitis, Ulcerative Clinical Trial

Official title:

Randomized-controlled Trial of Yoga for Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02043600
• Other study ID #: 13-5560-BO
• Status: Completed
• Phase: N/A
• First received: January 21, 2014
• Last updated: September 22, 2015
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Behavioral:
• Yoga
12-week Hatha Yoga intervention 90 minutes once a week
• Self-care
Self-care books are provided for self-directed use

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen	Essen

Sponsors (2)

Lead Sponsor	Collaborator
Universität Duisburg-Essen	Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	Intervention adherence (number of sessions attended and home practice diary)	3 months	No
Primary	Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBDQ)	3 months	No
Secondary	Disease-specific quality of life	Inflammatory Bowel Disease Questionnaire (IBDQ)	6 months	No
Secondary	Generic quality of life	36-Item Short Form Health Survey (SF-36)	3 months	No
Secondary	Generic quality of life	36-Item Short Form Health Survey (SF-36)	6 months	No
Secondary	Anxiety/depression	Hospital Anxiety and Depresion Scale (HADS)	3 months	No
Secondary	Anxiety/depression	Hospital Anxiety and Depresion Scale (HADS)	6 months	No
Secondary	Subjective stress	Perceived Stress Scale (PSS)	3 months	No
Secondary	Subjective stress	Perceived Stress Scale (PSS)	6 months	No
Secondary	Subjective stress	Perceived Stress Questionnaire (PSQ)	3 months	No
Secondary	Subjective stress	Perceived Stress Questionnaire (PSQ)	6 months	No
Secondary	Positive/negative affect	Positive and Negative Affect Schedule (PANAS)	3 months	No
Secondary	Positive/negative affect	Positive and Negative Affect Schedule (PANAS)	6 months	No
Secondary	Body awareness	Body Awareness Questionnaire (BAQ)	3 months	No
Secondary	Body awareness	Body Awareness Questionnaire (BAQ)	6 months	No
Secondary	Body responsiveness	Body Responsiveness Scale (BRS)	3 months	No
Secondary	Body responsiveness	Body Responsiveness Scale (BRS)	6 months	No
Secondary	Self-efficacy	General Self-Efficacy Scale	3 months	No
Secondary	Self-efficacy	General Self-Efficacy Scale	6 months	No
Secondary	C-reactive protein	C-reactive protein	3 months	No
Secondary	C-reactive protein	C-reactive protein	6 months	No
Secondary	Blood sedimentation rate	Blood sedimentation rate	3 months	No
Secondary	Blood sedimentation rate	Blood sedimentation rate	6 months	No
Secondary	Faecal calprotectin	Faecal calprotectin	3 months	No
Secondary	Faecal calprotectin	Faecal calprotectin	6 months	No
Secondary	Faecal lactoferrin	Faecal lactoferrin	3 months	No
Secondary	Faecal lactoferrin	Faecal lactoferrin	6 months	No
Secondary	Faecel PMN-elastase	Faecel PMN-elastase	3 months	No
Secondary	Faecel PMN-elastase	Faecel PMN-elastase	6 months	No
Secondary	Disease activity	Clinical Activity Index (CAI-Rachmilewitz)	3 months	No
Secondary	Disease activity	Clinical Activity Index (CAI-Rachmilewitz)	6 months	No
Secondary	Salivary cortisol level	Salivary cortisol level - cortisol awakening response	3 months	No
Secondary	Steroid sensitivity	Steroid sensitivity (IC50)	3 months	No
Secondary	Andrenergic sensitivity	Andrenergic sensitivity (IC50)	3 months	No
Secondary	Cholinergic sensitivity	Cholinergic sensitivity (IC50)	3 months	No
Secondary	Safety	Number of patients with adverse events/serious adverse events	3 months	Yes
Secondary	Safety	Number of patients with adverse events/serious adverse events	6 months	Yes
Secondary	Hemogram	Hemogram	3 months	No
Secondary	Hemogram	Hemogram	6 months	No