Trial record 2 of 194 for:    Open Studies | "Colitis, Ulcerative"

Randomized-controlled Trial of Yoga for Ulcerative Colitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Universität Duisburg-Essen
Sponsor:
Collaborator:
Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
Information provided by (Responsible Party):
Holger Cramer, Universität Duisburg-Essen
ClinicalTrials.gov Identifier:
NCT02043600
First received: January 21, 2014
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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 102 patients with ulcerative colitis.


Condition Intervention
Colitis, Ulcerative
Behavioral: Yoga
Behavioral: Self-care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized-controlled Trial of Yoga for Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Disease-specific quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)


Secondary Outcome Measures:
  • Disease-specific quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)

  • Disease-specific quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)

  • Disease-specific quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Inflammatory Bowel Disease Questionnaire (IBDQ)

  • Generic quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    36-Item Short Form Health Survey (SF-36)

  • Generic quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    36-Item Short Form Health Survey (SF-36)

  • Generic quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    36-Item Short Form Health Survey (SF-36)

  • Generic quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    36-Item Short Form Health Survey (SF-36)

  • Anxiety/depression [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depresion Scale (HADS)

  • Anxiety/depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depresion Scale (HADS)

  • Anxiety/depression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depresion Scale (HADS)

  • Anxiety/depression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depresion Scale (HADS)

  • Subjective stress [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Perceived Stress Scale (PSS)

  • Subjective stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Perceived Stress Scale (PSS)

  • Subjective stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Perceived Stress Scale (PSS)

  • Subjective stress [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Perceived Stress Scale (PSS)

  • Subjective stress [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Perceived Stress Questionnaire (PSQ)

  • Subjective stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Perceived Stress Questionnaire (PSQ)

  • Subjective stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Perceived Stress Questionnaire (PSQ)

  • Subjective stress [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Perceived Stress Questionnaire (PSQ)

  • Positive/negative affect [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Positive and Negative Affect Schedule (PANAS)

  • Positive/negative affect [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Positive and Negative Affect Schedule (PANAS)

  • Positive/negative affect [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Positive and Negative Affect Schedule (PANAS)

  • Positive/negative affect [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Positive and Negative Affect Schedule (PANAS)

  • Body awareness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body Awareness Questionnaire (BAQ)

  • Body awareness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body Awareness Questionnaire (BAQ)

  • Body awareness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Body Awareness Questionnaire (BAQ)

  • Body awareness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Body Awareness Questionnaire (BAQ)

  • Body responsiveness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Body Responsiveness Scale (BRS)

  • Body responsiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Body Responsiveness Scale (BRS)

  • Body responsiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Body Responsiveness Scale (BRS)

  • Body responsiveness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Body Responsiveness Scale (BRS)

  • Self-efficacy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    General Self-Efficacy Scale

  • Self-efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    General Self-Efficacy Scale

  • Self-efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    General Self-Efficacy Scale

  • Self-efficacy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    General Self-Efficacy Scale

  • C-reactive protein [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    C-reactive protein

  • C-reactive protein [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    C-reactive protein

  • Blood sedimentation rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Blood sedimentation rate

  • Blood sedimentation rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Blood sedimentation rate

  • Faecal calprotectin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Faecal calprotectin

  • Faecal calprotectin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Faecal calprotectin

  • Faecal lactoferrin [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Faecal lactoferrin

  • Faecal lactoferrin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Faecal lactoferrin

  • Faecel PMN-elastase [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Faecel PMN-elastase

  • Faecel PMN-elastase [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Faecel PMN-elastase

  • Disease activity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Clinical Activity Index (CAI-Rachmilewitz)

  • Disease activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical Activity Index (CAI-Rachmilewitz)

  • Disease activity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Clinical Activity Index (CAI-Rachmilewitz)

  • Disease activity [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Clinical Activity Index (CAI-Rachmilewitz)

  • Salivary cortisol level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Salivary cortisol level - cortisol awakening response

  • Steroid sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Steroid sensitivity (IC50)

  • Andrenergic sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Andrenergic sensitivity (IC50)

  • Cholinergic sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Cholinergic sensitivity (IC50)

  • Safety [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events/serious adverse events

  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events/serious adverse events

  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events/serious adverse events

  • Safety [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events/serious adverse events


Other Outcome Measures:
  • Adherence [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Intervention adherence (number of sessions attended and home practice diary)


Estimated Enrollment: 102
Study Start Date: February 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043600

Contacts
Contact: Holger Cramer, PhD +49 201 174-25054 h.cramer@kliniken-essen-mitte.de
Contact: Jost Langhorst, MD +49 201 174-25012 j.langhorst@kliniken-essen-mitte.de

Locations
Germany
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen Recruiting
Essen, Germany, 45276
Contact: Holger Cramer, PhD    +49 201 174-25054    h.cramer@kliniken-essen-mitte.de   
Contact: Jost Langhorst, MD    +49 201 174-25012    j.langhorst@kliniken-essen-mitte.de   
Principal Investigator: Holger Cramer, PhD         
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
  More Information

No publications provided

Responsible Party: Holger Cramer, Postdoctoral Researcher, Universität Duisburg-Essen
ClinicalTrials.gov Identifier: NCT02043600     History of Changes
Other Study ID Numbers: 13-5560-BO
Study First Received: January 21, 2014
Last Updated: February 17, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by 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

ClinicalTrials.gov processed this record on October 01, 2014