Clinical Trial: Randomized-controlled Trial of Yoga for Ulcerative Colitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized-controlled Trial of Yoga for Ulcerative Colitis

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.

Detailed Summary:
Sponsor: Universität Duisburg-Essen

Current Primary Outcome: Disease-specific quality of life [ Time Frame: 3 months ]

Inflammatory Bowel Disease Questionnaire (IBDQ)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    Ch

    Original Secondary Outcome:

    • 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 

      Information By: Universität Duisburg-Essen

      Dates:
      Date Received: January 21, 2014
      Date Started: February 2014
      Date Completion:
      Last Updated: September 22, 2015
      Last Verified: September 2015