ClinicalTrials.gg
CompletedNCT03651232Updated Aug 29, 2018

Prenatal Yoga for Pregnancy Related Back Pain

An interventional study of yoga and support group in Pregnancy Related, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled Apr 2015, registered Jul 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
Female
01

Study summary

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

02

Conditions studied

  • Pregnancy Related
03

In context

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 565 studies on the registry; 81 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 62 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • significant back pathology
  • pregnancy complications
  • non-English speaking
  • otherwise were not able to participate (eg. transportation, scheduling issues)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    yoga

    weekly prenatal yoga group class

    Behavioral: yoga

  • Active comparator
    support

    weekly group support class

    Behavioral: support group

Interventions

  • Behavioralyoga

    once weekly group yoga class for 12 weeks

  • Behavioralsupport group

    once weekly group support class for 12 weeks

06

What researchers measure

Primary outcomes

  1. feasibility of recruitment

    recruitment rate

    Time frame: baseline

Secondary outcomes

  1. back pain disability

    Roland Morris Disability Questionnaire (range 0-24), lower better

    Time frame: baseline, 4, 8, 12 weeks

  2. back pain severity

    Back Pain Severity Visual Analogue Scale (rage 0-10), lower better

    Time frame: baseline, 4, 8, 12 weeks

  3. pregnancy symptoms

    Pregnancy Symptom Inventory (range 0-123), lower better

    Time frame: baseline, 4, 8, 12 weeks

  4. depression

    Edinburgh Postnatal Depression Scale (range 0-30), lower better

    Time frame: baseline, 4, 8, 12 weeks

  5. quality of lfe

    Short Form-12 (range 12-56), higher better

    Time frame: baseline, 4, 8, 12 weeks

  6. childbirth experience

    Childbirth Experience (range 19-76), higher better

    Time frame: postpartum visit

  7. mobility lab- speed

    instrumented gait speed

    Time frame: baseline, 4, 8, 12 weeks

  8. acceptability

    class attendance

    Time frame: 4,8, 12 weeks, postpartum

  9. mobility lab- double support

    double support time

    Time frame: baseline, 4, 8, 12 weeks

  10. mobility lab- TUG

    timed up and go time

    Time frame: baseline, 4, 8, 12 weeks

  11. mobility lab- turn

    turn time

    Time frame: baseline, 4, 8, 12 weeks

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Jun 2016, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2018
First posted
Aug 29, 2018
StartActual
Apr 21, 2015
Primary completionActual
Jun 30, 2016
CompletionActual
Jun 30, 2016
Last update
Aug 29, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03651232
Responsible party
Gloria Y. Yeh (Associate Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Aug 29, 2018
Start date
Apr 21, 2015
Primary completion
Jun 30, 2016
Completion
Jun 30, 2016
Last update
Aug 29, 2018

Study contacts

Gloria Yeh
principal investigator · Beth Israel Deaconess Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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