Randomized-controlled Trial of Yoga for Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Randomized-controlled Trial of Yoga for Ulcerative Colitis

Conditions
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Colitis, Ulcerative

Intervention / Treatment
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* Behavioral: Yoga
* Behavioral: Self-care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br> | Behavioral: Yoga<br>* 12-week Hatha Yoga intervention 90 minutes once a week<br>|
| Active Comparator: Self-care<br> | Behavioral: Self-care<br>* Self-care books are provided for self-directed use<br>* Other names: Self-care book;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colitis, ulcerative, Yoga