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Randomized-controlled Trial of Yoga for Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT02043600
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : September 23, 2015
Sponsor:
Collaborator:
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
Information provided by (Responsible Party):
Holger Cramer, 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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Behavioral: Yoga Behavioral: Self-care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized-controlled Trial of Yoga for Ulcerative Colitis
Study Start Date : February 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga Behavioral: Yoga
12-week Hatha Yoga intervention 90 minutes once a week

Active Comparator: Self-care Behavioral: Self-care
Self-care books are provided for self-directed use
Other Name: Self-care book




Primary Outcome Measures :
  1. Disease-specific quality of life [ Time Frame: 3 months ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Adherence [ Time Frame: 3 months ]
    Intervention adherence (number of sessions attended and home practice diary)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02043600


Locations
Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
Investigators
Principal Investigator: Holger Cramer, PhD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
Study Director: Jost Langhorst, MD Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Holger Cramer, Postdoctoral Researcher, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02043600     History of Changes
Other Study ID Numbers: 13-5560-BO
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Holger Cramer, Universität Duisburg-Essen:
Colitis, ulcerative
Yoga

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases