Prenatal Yoga for Pregnancy Related Back Pain
Primary Purpose
Pregnancy Related
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
yoga
support group
Sponsored by
About this trial
This is an interventional treatment trial for Pregnancy Related
Eligibility Criteria
Inclusion Criteria:
- uncomplicated pregnancies starting at 12-26 weeks of gestation
- pregnant women with and without back pain who had no regular yoga practice.
Exclusion Criteria:
- significant back pathology
- pregnancy complications
- non-English speaking
- otherwise were not able to participate (eg. transportation, scheduling issues)
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
yoga
support
Arm Description
weekly prenatal yoga group class
weekly group support class
Outcomes
Primary Outcome Measures
feasibility of recruitment
recruitment rate
Secondary Outcome Measures
back pain disability
Roland Morris Disability Questionnaire (range 0-24), lower better
back pain severity
Back Pain Severity Visual Analogue Scale (rage 0-10), lower better
pregnancy symptoms
Pregnancy Symptom Inventory (range 0-123), lower better
depression
Edinburgh Postnatal Depression Scale (range 0-30), lower better
quality of lfe
Short Form-12 (range 12-56), higher better
childbirth experience
Childbirth Experience (range 19-76), higher better
mobility lab- speed
instrumented gait speed
acceptability
class attendance
mobility lab- double support
double support time
mobility lab- TUG
timed up and go time
mobility lab- turn
turn time
Full Information
NCT ID
NCT03651232
First Posted
July 9, 2018
Last Updated
August 27, 2018
Sponsor
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03651232
Brief Title
Prenatal Yoga for Pregnancy Related Back Pain
Official Title
Prenatal Yoga for Pregnancy Related Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 21, 2015 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Related
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
yoga
Arm Type
Experimental
Arm Description
weekly prenatal yoga group class
Arm Title
support
Arm Type
Active Comparator
Arm Description
weekly group support class
Intervention Type
Behavioral
Intervention Name(s)
yoga
Intervention Description
once weekly group yoga class for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
support group
Intervention Description
once weekly group support class for 12 weeks
Primary Outcome Measure Information:
Title
feasibility of recruitment
Description
recruitment rate
Time Frame
baseline
Secondary Outcome Measure Information:
Title
back pain disability
Description
Roland Morris Disability Questionnaire (range 0-24), lower better
Time Frame
baseline, 4, 8, 12 weeks
Title
back pain severity
Description
Back Pain Severity Visual Analogue Scale (rage 0-10), lower better
Time Frame
baseline, 4, 8, 12 weeks
Title
pregnancy symptoms
Description
Pregnancy Symptom Inventory (range 0-123), lower better
Time Frame
baseline, 4, 8, 12 weeks
Title
depression
Description
Edinburgh Postnatal Depression Scale (range 0-30), lower better
Time Frame
baseline, 4, 8, 12 weeks
Title
quality of lfe
Description
Short Form-12 (range 12-56), higher better
Time Frame
baseline, 4, 8, 12 weeks
Title
childbirth experience
Description
Childbirth Experience (range 19-76), higher better
Time Frame
postpartum visit
Title
mobility lab- speed
Description
instrumented gait speed
Time Frame
baseline, 4, 8, 12 weeks
Title
acceptability
Description
class attendance
Time Frame
4,8, 12 weeks, postpartum
Title
mobility lab- double support
Description
double support time
Time Frame
baseline, 4, 8, 12 weeks
Title
mobility lab- TUG
Description
timed up and go time
Time Frame
baseline, 4, 8, 12 weeks
Title
mobility lab- turn
Description
turn time
Time Frame
baseline, 4, 8, 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
uncomplicated pregnancies starting at 12-26 weeks of gestation
pregnant women with and without back pain who had no regular yoga practice.
Exclusion Criteria:
significant back pathology
pregnancy complications
non-English speaking
otherwise were not able to participate (eg. transportation, scheduling issues)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Yeh
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prenatal Yoga for Pregnancy Related Back Pain
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