Colitis, Ulcerative
Conditions
Keywords
Colitis, ulcerative, Yoga
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.
Interventions
BEHAVIORALYoga
12-week Hatha Yoga intervention 90 minutes once a week
BEHAVIORALSelf-care
Self-care books are provided for self-directed use
Sponsors
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-specific quality of life | 3 months | Inflammatory Bowel Disease Questionnaire (IBDQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body awareness | 3 months | Body Awareness Questionnaire (BAQ) |
| Body responsiveness | 3 months | Body Responsiveness Scale (BRS) |
| Self-efficacy | 3 months | General Self-Efficacy Scale |
| C-reactive protein | 3 months | C-reactive protein |
| Blood sedimentation rate | 3 months | Blood sedimentation rate |
| Faecal calprotectin | 3 months | Faecal calprotectin |
| Faecal lactoferrin | 3 months | Faecal lactoferrin |
| Faecel PMN-elastase | 3 months | Faecel PMN-elastase |
| Positive/negative affect | 3 months | Positive and Negative Affect Schedule (PANAS) |
| Subjective stress | 3 months | Perceived Stress Scale (PSS) |
| Generic quality of life | 3 months | 36-Item Short Form Health Survey (SF-36) |
| Anxiety/depression | 3 months | Hospital Anxiety and Depresion Scale (HADS) |
| Disease activity | 3 months | Clinical Activity Index (CAI-Rachmilewitz) |
| Salivary cortisol level | 3 months | Salivary cortisol level - cortisol awakening response |
| Steroid sensitivity | 3 months | Steroid sensitivity (IC50) |
| Andrenergic sensitivity | 3 months | Andrenergic sensitivity (IC50) |
| Cholinergic sensitivity | 3 months | Cholinergic sensitivity (IC50) |
| Safety | 3 months | Number of patients with adverse events/serious adverse events |
| Hemogram | 3 months | Hemogram |
| Disease-specific quality of life | 6 months | Inflammatory Bowel Disease Questionnaire (IBDQ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence | 3 months | Intervention adherence (number of sessions attended and home practice diary) |
Countries
Germany
Outcome results
None listed