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Completed

NCT Number: NCT02043600

Randomized-controlled Trial of Yoga for Ulcerative Colitis

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.

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Key information

Conditions

Colitis, Ulcerative Colitis Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen

Essen, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yoga

Behavioral

12-week Hatha Yoga intervention 90 minutes once a week

self-care

Behavioral

Self-care books are provided for self-directed use

Other names: Self-care book

Primary outcomes

  1. Disease-specific quality of life

    Time frame: 3 months

    Inflammatory Bowel Disease Questionnaire (IBDQ)

Secondary outcomes

  1. Disease-specific quality of life

    Time frame: 6 months

    Inflammatory Bowel Disease Questionnaire (IBDQ)

  2. Generic quality of life

    Time frame: 3 months

    36-Item Short Form Health Survey (SF-36)

  3. Generic quality of life

    Time frame: 6 months

    36-Item Short Form Health Survey (SF-36)

  4. Anxiety/depression

    Time frame: 3 months

    Hospital Anxiety and Depresion Scale (HADS)

  5. Anxiety/depression

    Time frame: 6 months

    Hospital Anxiety and Depresion Scale (HADS)

  6. Subjective stress

    Time frame: 3 months

    Perceived Stress Scale (PSS)

  7. Subjective stress

    Time frame: 6 months

    Perceived Stress Scale (PSS)

  8. Subjective stress

    Time frame: 3 months

    Perceived Stress Questionnaire (PSQ)

  9. Subjective stress

    Time frame: 6 months

    Perceived Stress Questionnaire (PSQ)

  10. Positive/negative affect

    Time frame: 3 months

    Positive and Negative Affect Schedule (PANAS)

  11. Positive/negative affect

    Time frame: 6 months

    Positive and Negative Affect Schedule (PANAS)

  12. Body awareness

    Time frame: 3 months

    Body Awareness Questionnaire (BAQ)

  13. Body awareness

    Time frame: 6 months

    Body Awareness Questionnaire (BAQ)

  14. Body responsiveness

    Time frame: 3 months

    Body Responsiveness Scale (BRS)

  15. Body responsiveness

    Time frame: 6 months

    Body Responsiveness Scale (BRS)

  16. Self-efficacy

    Time frame: 3 months

    General Self-Efficacy Scale

  17. Self-efficacy

    Time frame: 6 months

    General Self-Efficacy Scale

  18. C-reactive protein

    Time frame: 3 months

    C-reactive protein

  19. C-reactive protein

    Time frame: 6 months

    C-reactive protein

  20. Blood sedimentation rate

    Time frame: 3 months

    Blood sedimentation rate

  21. Blood sedimentation rate

    Time frame: 6 months

    Blood sedimentation rate

  22. Faecal calprotectin

    Time frame: 3 months

    Faecal calprotectin

  23. Faecal calprotectin

    Time frame: 6 months

    Faecal calprotectin

  24. Faecal lactoferrin

    Time frame: 3 months

    Faecal lactoferrin

  25. Faecal lactoferrin

    Time frame: 6 months

    Faecal lactoferrin

  26. Faecel PMN-elastase

    Time frame: 3 months

    Faecel PMN-elastase

  27. Faecel PMN-elastase

    Time frame: 6 months

    Faecel PMN-elastase

  28. Disease activity

    Time frame: 3 months

    Clinical Activity Index (CAI-Rachmilewitz)

  29. Disease activity

    Time frame: 6 months

    Clinical Activity Index (CAI-Rachmilewitz)

  30. Salivary cortisol level

    Time frame: 3 months

    Salivary cortisol level - cortisol awakening response

  31. Steroid sensitivity

    Time frame: 3 months

    Steroid sensitivity (IC50)

  32. Andrenergic sensitivity

    Time frame: 3 months

    Andrenergic sensitivity (IC50)

  33. Cholinergic sensitivity

    Time frame: 3 months

    Cholinergic sensitivity (IC50)

  34. Safety

    Time frame: 3 months

    Number of patients with adverse events/serious adverse events

  35. Safety

    Time frame: 6 months

    Number of patients with adverse events/serious adverse events

  36. Hemogram

    Time frame: 3 months

    Hemogram

  37. Hemogram

    Time frame: 6 months

    Hemogram

Other outcomes

  1. Adherence

    Time frame: 3 months

    Intervention adherence (number of sessions attended and home practice diary)

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Collaborators

  • Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 23, 2014
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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