Clinical trial NCT02043600: Randomized-controlled Trial of Yoga for Ulcerative Colitis
Official title: Randomized-controlled Trial of Yoga for Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis, Ulcerative
Keywords: Colitis, ulcerative
Yoga
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
Collaborators: name: Deutsche Morbus Crohn / Colitis ulcerosa Vereinigung DCCV
First posted: 2014-01-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Disease-specific quality of life
timeFrame: 3 months
Secondary outcomes:
measure: Disease-specific quality of life
timeFrame: 6 months
measure: Generic quality of life
timeFrame: 3 months
measure: Generic quality of life
timeFrame: 6 months
measure: Anxiety/depression
timeFrame: 3 months
measure: Anxiety/depression
timeFrame: 6 months
measure: Subjective stress
timeFrame: 3 months
measure: Subjective stress
timeFrame: 6 months
measure: Subjective stress
timeFrame: 3 months
measure: Subjective stress
timeFrame: 6 months
measure: Positive/negative affect
timeFrame: 3 months
measure: Positive/negative affect
timeFrame: 6 months
measure: Body awareness
timeFrame: 3 months
measure: Body awareness
timeFrame: 6 months
measure: Body responsiveness
timeFrame: 3 months
measure: Body responsiveness
timeFrame: 6 months
measure: Self-efficacy
timeFrame: 3 months
measure: Self-efficacy
timeFrame: 6 months
measure: C-reactive protein
timeFrame: 3 months
measure: C-reactive protein
timeFrame: 6 months
measure: Blood sedimentation rate
timeFrame: 3 months
measure: Blood sedimentation rate
timeFrame: 6 months
measure: Faecal calprotectin
timeFrame: 3 months
measure: Faecal calprotectin
timeFrame: 6 months
measure: Faecal lactoferrin
timeFrame: 3 months
measure: Faecal lactoferrin
timeFrame: 6 months
measure: Faecel PMN-elastase
timeFrame: 3 months
measure: Faecel PMN-elastase
timeFrame: 6 months
measure: Disease activity
timeFrame: 3 months
measure: Disease activity
timeFrame: 6 months
measure: Salivary cortisol level
timeFrame: 3 months
measure: Steroid sensitivity
timeFrame: 3 months
measure: Andrenergic sensitivity
timeFrame: 3 months
measure: Cholinergic sensitivity
timeFrame: 3 months
measure: Safety
timeFrame: 3 months
measure: Safety
timeFrame: 6 months
measure: Hemogram
timeFrame: 3 months
measure: Hemogram
timeFrame: 6 months
Other outcomes:
measure: Adherence
timeFrame: 3 months
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
name: Holger Cramer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen, Essen, Germany
name: Jost Langhorst, MD
role: STUDY_DIRECTOR
References:
citation: Koch AK, Schols M, Langhorst J, Dobos G, Cramer H. Perceived stress mediates the effect of yoga on quality of life and disease activity in ulcerative colitis. Secondary analysis of a randomized controlled trial. J Psychosom Res. 2020 Mar;130:109917. doi: 10.1016/j.jpsychores.2019.109917. Epub 2019 Dec 31.
citation: Cramer H, Schafer M, Schols M, Kocke 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.