Randomized-controlled Trial of Yoga for Ulcerative Colitis

Not Applicable

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Behavioral: Self-care; Behavioral: Yoga

• Registration Number: NCT02043600
• Lead Sponsor: Universität Duisburg-Essen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-21
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-23
• Study Start: 2014-02
• Primary Completion: 2015-05
• Study Completion: 2015-08
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-care	Self-care	-
Yoga	Yoga	-

Primary Outcome Measures

Name	Time	Method
Disease-specific quality of life	3 months	Inflammatory Bowel Disease Questionnaire (IBDQ)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen; 🇩🇪 Essen, Germany