NCT03651232

Brief Summary

This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.2 years

First QC Date

July 9, 2018

Last Update Submit

August 27, 2018

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • feasibility of recruitment

    recruitment rate

    baseline

Secondary Outcomes (11)

  • back pain disability

    baseline, 4, 8, 12 weeks

  • back pain severity

    baseline, 4, 8, 12 weeks

  • pregnancy symptoms

    baseline, 4, 8, 12 weeks

  • depression

    baseline, 4, 8, 12 weeks

  • quality of lfe

    baseline, 4, 8, 12 weeks

  • +6 more secondary outcomes

Study Arms (2)

yoga

EXPERIMENTAL

weekly prenatal yoga group class

Behavioral: yoga

support

ACTIVE COMPARATOR

weekly group support class

Behavioral: support group

Interventions

yogaBEHAVIORAL

once weekly group yoga class for 12 weeks

yoga
support groupBEHAVIORAL

once weekly group support class for 12 weeks

support

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • uncomplicated pregnancies starting at 12-26 weeks of gestation
  • pregnant women with and without back pain who had no regular yoga practice.

You may not qualify if:

  • significant back pathology
  • pregnancy complications
  • non-English speaking
  • otherwise were not able to participate (eg. transportation, scheduling issues)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

YogaSelf-Help Groups

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy ModalitiesOrganizationsHealth Care Economics and Organizations

Study Officials

  • Gloria Yeh

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine, Harvard Medical School

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 29, 2018

Study Start

April 21, 2015

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)