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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

January 21, 2014
January 23, 2014
September 23, 2015
February 2014
May 2015   (Final data collection date for primary outcome measure)
Disease-specific quality of life [ Time Frame: 3 months ]
Inflammatory Bowel Disease Questionnaire (IBDQ)
Same as current
Complete list of historical versions of study NCT02043600 on ClinicalTrials.gov Archive Site
  • Disease-specific quality of life [ Time Frame: 6 months ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Generic quality of life [ Time Frame: 3 months ]
    36-Item Short Form Health Survey (SF-36)
  • Generic quality of life [ Time Frame: 6 months ]
    36-Item Short Form Health Survey (SF-36)
  • Anxiety/depression [ Time Frame: 3 months ]
    Hospital Anxiety and Depresion Scale (HADS)
  • Anxiety/depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depresion Scale (HADS)
  • Subjective stress [ Time Frame: 3 months ]
    Perceived Stress Scale (PSS)
  • Subjective stress [ Time Frame: 6 months ]
    Perceived Stress Scale (PSS)
  • Subjective stress [ Time Frame: 3 months ]
    Perceived Stress Questionnaire (PSQ)
  • Subjective stress [ Time Frame: 6 months ]
    Perceived Stress Questionnaire (PSQ)
  • Positive/negative affect [ Time Frame: 3 months ]
    Positive and Negative Affect Schedule (PANAS)
  • Positive/negative affect [ Time Frame: 6 months ]
    Positive and Negative Affect Schedule (PANAS)
  • Body awareness [ Time Frame: 3 months ]
    Body Awareness Questionnaire (BAQ)
  • Body awareness [ Time Frame: 6 months ]
    Body Awareness Questionnaire (BAQ)
  • Body responsiveness [ Time Frame: 3 months ]
    Body Responsiveness Scale (BRS)
  • Body responsiveness [ Time Frame: 6 months ]
    Body Responsiveness Scale (BRS)
  • Self-efficacy [ Time Frame: 3 months ]
    General Self-Efficacy Scale
  • Self-efficacy [ Time Frame: 6 months ]
    General Self-Efficacy Scale
  • C-reactive protein [ Time Frame: 3 months ]
    C-reactive protein
  • C-reactive protein [ Time Frame: 6 months ]
    C-reactive protein
  • Blood sedimentation rate [ Time Frame: 3 months ]
    Blood sedimentation rate
  • Blood sedimentation rate [ Time Frame: 6 months ]
    Blood sedimentation rate
  • Faecal calprotectin [ Time Frame: 3 months ]
    Faecal calprotectin
  • Faecal calprotectin [ Time Frame: 6 months ]
    Faecal calprotectin
  • Faecal lactoferrin [ Time Frame: 3 months ]
    Faecal lactoferrin
  • Faecal lactoferrin [ Time Frame: 6 months ]
    Faecal lactoferrin
  • Faecel PMN-elastase [ Time Frame: 3 months ]
    Faecel PMN-elastase
  • Faecel PMN-elastase [ Time Frame: 6 months ]
    Faecel PMN-elastase
  • Disease activity [ Time Frame: 3 months ]
    Clinical Activity Index (CAI-Rachmilewitz)
  • Disease activity [ Time Frame: 6 months ]
    Clinical Activity Index (CAI-Rachmilewitz)
  • Salivary cortisol level [ Time Frame: 3 months ]
    Salivary cortisol level - cortisol awakening response
  • Steroid sensitivity [ Time Frame: 3 months ]
    Steroid sensitivity (IC50)
  • Andrenergic sensitivity [ Time Frame: 3 months ]
    Andrenergic sensitivity (IC50)
  • Cholinergic sensitivity [ Time Frame: 3 months ]
    Cholinergic sensitivity (IC50)
  • Safety [ Time Frame: 3 months ]
    Number of patients with adverse events/serious adverse events
  • Safety [ Time Frame: 6 months ]
    Number of patients with adverse events/serious adverse events
  • Hemogram [ Time Frame: 3 months ]
    Hemogram
  • Hemogram [ Time Frame: 6 months ]
    Hemogram
  • Disease-specific quality of life [ Time Frame: 6 months ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Disease-specific quality of life [ Time Frame: 12 months ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Disease-specific quality of life [ Time Frame: 24 months ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)
  • Generic quality of life [ Time Frame: 3 months ]
    36-Item Short Form Health Survey (SF-36)
  • Generic quality of life [ Time Frame: 6 months ]
    36-Item Short Form Health Survey (SF-36)
  • Generic quality of life [ Time Frame: 12 months ]
    36-Item Short Form Health Survey (SF-36)
  • Generic quality of life [ Time Frame: 24 months ]
    36-Item Short Form Health Survey (SF-36)
  • Anxiety/depression [ Time Frame: 3 months ]
    Hospital Anxiety and Depresion Scale (HADS)
  • Anxiety/depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depresion Scale (HADS)
  • Anxiety/depression [ Time Frame: 12 months ]
    Hospital Anxiety and Depresion Scale (HADS)
  • Anxiety/depression [ Time Frame: 24 months ]
    Hospital Anxiety and Depresion Scale (HADS)
  • Subjective stress [ Time Frame: 3 months ]
    Perceived Stress Scale (PSS)
  • Subjective stress [ Time Frame: 6 months ]
    Perceived Stress Scale (PSS)
  • Subjective stress [ Time Frame: 12 months ]
    Perceived Stress Scale (PSS)
  • Subjective stress [ Time Frame: 24 months ]
    Perceived Stress Scale (PSS)
  • Subjective stress [ Time Frame: 3 months ]
    Perceived Stress Questionnaire (PSQ)
  • Subjective stress [ Time Frame: 6 months ]
    Perceived Stress Questionnaire (PSQ)
  • Subjective stress [ Time Frame: 12 months ]
    Perceived Stress Questionnaire (PSQ)
  • Subjective stress [ Time Frame: 24 months ]
    Perceived Stress Questionnaire (PSQ)
  • Positive/negative affect [ Time Frame: 3 months ]
    Positive and Negative Affect Schedule (PANAS)
  • Positive/negative affect [ Time Frame: 6 months ]
    Positive and Negative Affect Schedule (PANAS)
  • Positive/negative affect [ Time Frame: 12 months ]
    Positive and Negative Affect Schedule (PANAS)
  • Positive/negative affect [ Time Frame: 24 months ]
    Positive and Negative Affect Schedule (PANAS)
  • Body awareness [ Time Frame: 3 months ]
    Body Awareness Questionnaire (BAQ)
  • Body awareness [ Time Frame: 6 months ]
    Body Awareness Questionnaire (BAQ)
  • Body awareness [ Time Frame: 12 months ]
    Body Awareness Questionnaire (BAQ)
  • Body awareness [ Time Frame: 24 months ]
    Body Awareness Questionnaire (BAQ)
  • Body responsiveness [ Time Frame: 3 months ]
    Body Responsiveness Scale (BRS)
  • Body responsiveness [ Time Frame: 6 months ]
    Body Responsiveness Scale (BRS)
  • Body responsiveness [ Time Frame: 12 months ]
    Body Responsiveness Scale (BRS)
  • Body responsiveness [ Time Frame: 24 months ]
    Body Responsiveness Scale (BRS)
  • Self-efficacy [ Time Frame: 3 months ]
    General Self-Efficacy Scale
  • Self-efficacy [ Time Frame: 6 months ]
    General Self-Efficacy Scale
  • Self-efficacy [ Time Frame: 12 months ]
    General Self-Efficacy Scale
  • Self-efficacy [ Time Frame: 24 months ]
    General Self-Efficacy Scale
  • C-reactive protein [ Time Frame: 3 months ]
    C-reactive protein
  • C-reactive protein [ Time Frame: 6 months ]
    C-reactive protein
  • Blood sedimentation rate [ Time Frame: 3 months ]
    Blood sedimentation rate
  • Blood sedimentation rate [ Time Frame: 6 months ]
    Blood sedimentation rate
  • Faecal calprotectin [ Time Frame: 3 months ]
    Faecal calprotectin
  • Faecal calprotectin [ Time Frame: 6 months ]
    Faecal calprotectin
  • Faecal lactoferrin [ Time Frame: 3 months ]
    Faecal lactoferrin
  • Faecal lactoferrin [ Time Frame: 6 months ]
    Faecal lactoferrin
  • Faecel PMN-elastase [ Time Frame: 3 months ]
    Faecel PMN-elastase
  • Faecel PMN-elastase [ Time Frame: 6 months ]
    Faecel PMN-elastase
  • Disease activity [ Time Frame: 3 months ]
    Clinical Activity Index (CAI-Rachmilewitz)
  • Disease activity [ Time Frame: 6 months ]
    Clinical Activity Index (CAI-Rachmilewitz)
  • Disease activity [ Time Frame: 12 months ]
    Clinical Activity Index (CAI-Rachmilewitz)
  • Disease activity [ Time Frame: 24 months ]
    Clinical Activity Index (CAI-Rachmilewitz)
  • Salivary cortisol level [ Time Frame: 3 months ]
    Salivary cortisol level - cortisol awakening response
  • Steroid sensitivity [ Time Frame: 3 months ]
    Steroid sensitivity (IC50)
  • Andrenergic sensitivity [ Time Frame: 3 months ]
    Andrenergic sensitivity (IC50)
  • Cholinergic sensitivity [ Time Frame: 3 months ]
    Cholinergic sensitivity (IC50)
  • Safety [ Time Frame: 3 months ]
    Number of patients with adverse events/serious adverse events
  • Safety [ Time Frame: 6 months ]
    Number of patients with adverse events/serious adverse events
  • Safety [ Time Frame: 12 months ]
    Number of patients with adverse events/serious adverse events
  • Safety [ Time Frame: 24 months ]
    Number of patients with adverse events/serious adverse events
Adherence [ Time Frame: 3 months ]
Intervention adherence (number of sessions attended and home practice diary)
Same as current
 
Randomized-controlled Trial of Yoga for Ulcerative Colitis
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Colitis, Ulcerative
  • Behavioral: Yoga
    12-week Hatha Yoga intervention 90 minutes once a week
  • Behavioral: Self-care
    Self-care books are provided for self-directed use
    Other Name: Self-care book
  • Experimental: Yoga
    Intervention: Behavioral: Yoga
  • Active Comparator: Self-care
    Intervention: Behavioral: Self-care
Cramer H, Schäfer M, Schöls M, Köcke J, Elsenbruch S, Lauche R, Engler H, Dobos G, Langhorst J. Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis. Aliment Pharmacol Ther. 2017 Jun;45(11):1379-1389. doi: 10.1111/apt.14062. Epub 2017 Apr 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
102
August 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02043600
13-5560-BO
No
Not Provided
Not Provided
Holger Cramer, Universität Duisburg-Essen
Universität Duisburg-Essen
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
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
Universität Duisburg-Essen
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP