NCT02043600CompletedNot Applicable
Randomized-controlled Trial of Yoga for Ulcerative Colitis
Universität Duisburg-Essen1 site in 1 country77 target enrollmentStarted: February 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Disease-specific quality of life
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •Pregnancy
Arms & Interventions
Yoga
Experimental
Intervention: Yoga (Behavioral)
Self-care
Active Comparator
Intervention: Self-care (Behavioral)
Outcomes
Primary Outcomes
Disease-specific quality of life
Time Frame: 3 months
Inflammatory Bowel Disease Questionnaire (IBDQ)
Secondary Outcomes
- Body responsiveness(6 months)
- Disease-specific quality of life(6 months)
- Subjective stress(6 months)
- Faecal lactoferrin(6 months)
- Disease activity(6 months)
- Safety(6 months)
- Generic quality of life(6 months)
- Body awareness(6 months)
- C-reactive protein(6 months)
- Faecal calprotectin(6 months)
- Salivary cortisol level(3 months)
- Steroid sensitivity(3 months)
- Self-efficacy(6 months)
- Blood sedimentation rate(6 months)
- Faecel PMN-elastase(6 months)
- Anxiety/depression(6 months)
- Hemogram(6 months)
- Positive/negative affect(6 months)
- Andrenergic sensitivity(3 months)
- Cholinergic sensitivity(3 months)
- Faecel PMN-elastase(3 months)
- Self-efficacy(3 months)
- Faecal lactoferrin(3 months)
- Generic quality of life(3 months)
- Anxiety/depression(3 months)
- Subjective stress(3 months)
- Positive/negative affect(3 months)
- Body awareness(3 months)
- Body responsiveness(3 months)
- C-reactive protein(3 months)
- Blood sedimentation rate(3 months)
- Faecal calprotectin(3 months)
- Disease activity(3 months)
- Safety(3 months)
- Hemogram(3 months)
Investigators
Holger Cramer
Postdoctoral Researcher
Universität Duisburg-Essen
Study Sites (1)
Loading locations...
Similar Trials
Completed
Not Applicable
Yoga for Abdominal ObesityObesity, AbdominalNCT02420145Universität Duisburg-Essen60
Withdrawn
Not Applicable
The Utilization of Yoga as a Therapeutic Tool to Promote Physical Activity Behavior Change and Improved Postural Control in Individuals With Multiple SclerosisMultiple SclerosisNCT04113135Winston Salem State University
Completed
Not Applicable
Yoga for Patients With Irritable Bowel SyndromeIrritable Bowel SyndromeNCT02721836Universität Duisburg-Essen59
Completed
Not Applicable
Multiple Myeloma Yoga Pilot StudyMultiple MyelomaNCT06061302University of Arizona31
Active, not recruiting
Not Applicable
IMPOWR-ME Project 1: Trial of Yoga and Physical Therapy Onsite at Opioid Treatment ProgramsBack Pain Lower Back ChronicChronic PainOpioid Use DisorderSubstance Use DisordersNCT05492825Albert Einstein College of Medicine180