NCT03338894

A Trial of Yoga in Pediatric Inflammatory Bowel Disease

Completed NA Results posted Last updated 18 September 2023

What this trial tests

NA trial testing Yoga in Inflammatory Bowel Disease in 78 participants. Completed in 31 December 2021.

Timeline

13 December 2017

Primary endpoint
18 March 2020

31 December 2021

Quick facts

Lead sponsor	Atlantic Health System
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	78
Start date	13 December 2017
Primary completion	18 March 2020
Estimated completion	31 December 2021
Sites	2 locations across United States

Drugs / interventions tested

• Yoga

Conditions studied

• Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →
• Crohn's Disease — all drugs for Crohn's Disease →
• Ulcerative Colitis — all drugs for Ulcerative Colitis →

Sponsor

Atlantic Health System — full company profile →

Who can join

Adults 10 to 17, any sex, with Inflammatory Bowel Disease or Crohn's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pediatric Quality of Life Inventory Primary · Compared difference from enrollment (time0) to start yoga class (time1), to difference from first yoga class (time1) to last yoga class (time2) 90 days, difference from first yoga class (time1) to 3 months after last yoga class (time 3) 180 days.

The number of patients diagnosed with Inflammatory Bowel disease that have shown an improved health related quality of life (HRQOL) as assessed by the Pediatric Quality of Life survey after a structured yoga program, comparing pre-yoga HRQOL to post-yoga HRQOL. The Peds QOL age related surveys are validated pediatric questionnaires that measure general HRQOL in children ages 8-17 years. They consist of 23 questions in areas of social, school, emotional and physical functioning. The answers are scored on a 5 point scale and then reverse scored and linearly transformed to a scale of 1-100 scale.

time 0 to time 1

Group	Value	95% CI
Yoga Group	2.14	± 8.79

time 1 to time 2

Group	Value	95% CI
Yoga Group	1.5	± 8.01

time 1 to time 3

Group	Value	95% CI
Yoga Group	2.8	± 10.24

General Perceived Self Efficacy Scale Secondary · Compared difference from enrollment (time0) to start yoga class (time1), to difference from first yoga class (time1) to last yoga class (time2) 90 days, difference from first yoga class (time1) to 3 months after last yoga class (time 3) 180 days.

This is a 10 item scale that measures a patient's general sense of perceived self-efficacy, aiming to predict coping with daily life as well as adaptation after stressful life events. The General Self Efficacy Scale is correlated to emotion, optimism, and work satisfaction. Negative coefficients were found for depression, stress, health complaints, burnout and anxiety. The total score is calculated by finding the sum of all item. For the General Self-Efficacy, the total score ranges between 10 to 40, with a higher score indicating more self-efficacy.

Time 0 to Time 1

Group	Value	95% CI
Yoga Group	0.27	± 3.89

Time 1 to Time 2

Group	Value	95% CI
Yoga Group	0.4	± 4.32

Time 1 to Time 3

Group	Value	95% CI
Yoga Group	1	± 3.603

Sponsor's own description

IBD adds additional stressors as a chronic disease that has unpredictable and sometimes embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful events are perceived, may contribute to worsening of disease. Complementary and alternative medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing stress and improving quality of life. Yoga could be a well suited paring with standard medical therapy to decrease and provide a better sense of control and improve quality of life.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.