Trial Outcomes & Findings for A Trial of Yoga in Pediatric Inflammatory Bowel Disease (NCT NCT03338894)
NCT ID: NCT03338894
Last Updated: 2023-09-18
Results Overview
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.
COMPLETED
NA
78 participants
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.
2023-09-18
Participant Flow
Study enrollment was offered during office or infusion visit. Recruitment began December 2017 and closed August 2019.
Participant milestones
| Measure |
Yoga Group
Each subject will serve as their own control
Yoga: 1 Hour yoga class
|
|---|---|
|
Overall Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
56
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Yoga Group
Each subject will serve as their own control
Yoga: 1 Hour yoga class
|
|---|---|
|
Overall Study
Withdrew, or not able to attend 9 or more classes, or did not complete final survey.
|
22
|
Baseline Characteristics
A Trial of Yoga in Pediatric Inflammatory Bowel Disease
Baseline characteristics by cohort
| Measure |
Yoga Group
n=56 Participants
Each subject will serve as their own control
Yoga: 1 Hour yoga class
|
|---|---|
|
Age, Continuous
|
13 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=99 Participants
|
|
Inflammatory Bowel Disease Type
Crohn's Disease
|
41 Participants
n=99 Participants
|
|
Inflammatory Bowel Disease Type
Ulcerative Colitis/Inflammatory Bowel Disease unspecified
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Yoga Group
n=54 Participants
Each subject will serve as their own control
Yoga: 1 Hour yoga class
|
|---|---|
|
Pediatric Quality of Life Inventory
time 0 to time 1
|
2.14 score on a scale
Standard Deviation 8.79
|
|
Pediatric Quality of Life Inventory
time 1 to time 2
|
1.5 score on a scale
Standard Deviation 8.01
|
|
Pediatric Quality of Life Inventory
time 1 to time 3
|
2.8 score on a scale
Standard Deviation 10.24
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Yoga Group
n=54 Participants
Each subject will serve as their own control
Yoga: 1 Hour yoga class
|
|---|---|
|
General Perceived Self Efficacy Scale
Time 0 to Time 1
|
0.27 score on a scale
Standard Deviation 3.89
|
|
General Perceived Self Efficacy Scale
Time 1 to Time 2
|
0.4 score on a scale
Standard Deviation 4.32
|
|
General Perceived Self Efficacy Scale
Time 1 to Time 3
|
1 score on a scale
Standard Deviation 3.603
|
Adverse Events
Yoga Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alycia Leiby
Atlantic Children's Health/Atlantic Health Outpatient
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place