Pregnancy RelatedNCT03651232
Prenatal Yoga for Pregnancy Related Back Pain
A study testing yoga and support group in people with Pregnancy Related, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- yoga and support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2015to 30 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- uncomplicated pregnancies starting at 12-26 weeks of gestation
- pregnant women with and without back pain who had no regular yoga practice.
Who cannot join
- significant back pathology
- pregnancy complications
- non-English speaking
- otherwise were not able to participate (eg. transportation, scheduling issues)
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.
- Conditions
- Pregnancy Related
- Being tested
- yoga, support group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
once weekly group yoga class for 12 weeks
support groupBehavioural
once weekly group support class for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| yoga | Experimental | weekly prenatal yoga group class Receives: Behavioral: yoga |
| support | Active comparator | weekly group support class Receives: Behavioral: support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of recruitment
recruitment rate
Measured: baseline
Secondary outcomes (11)
back pain disability
Roland Morris Disability Questionnaire (range 0-24), lower better
Measured: baseline, 4, 8, 12 weeks
back pain severity
Back Pain Severity Visual Analogue Scale (rage 0-10), lower better
Measured: baseline, 4, 8, 12 weeks
pregnancy symptoms
Pregnancy Symptom Inventory (range 0-123), lower better
Measured: baseline, 4, 8, 12 weeks
depression
Edinburgh Postnatal Depression Scale (range 0-30), lower better
Measured: baseline, 4, 8, 12 weeks
quality of lfe
Short Form-12 (range 12-56), higher better
Measured: baseline, 4, 8, 12 weeks
childbirth experience
Childbirth Experience (range 19-76), higher better
Measured: postpartum visit
mobility lab- speed
instrumented gait speed
Measured: baseline, 4, 8, 12 weeks
acceptability
class attendance
Measured: 4,8, 12 weeks, postpartum
mobility lab- double support
double support time
Measured: baseline, 4, 8, 12 weeks
mobility lab- TUG
timed up and go time
Measured: baseline, 4, 8, 12 weeks
mobility lab- turn
turn time
Measured: baseline, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start21 Apr 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gloria Y. Yeh, Beth Israel Deaconess Medical Center
- Investigators
- Gloria Yeh, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651232
- Sponsor's protocol ID
- 2014P000344
- Status last verified
- Aug 2018
- First submitted
- 9 Jul 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Yoga for Pregnancy Related Back Pain
- ClinicalTrials.gov ID
- NCT03651232
- Acronym / sponsor ID
- 2014P000344
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 21 Apr 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot feasibility study investigating prenatal yoga for pregnancy related back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga | Experimental | Behavioral: yogaweekly prenatal yoga group class |
| support | Active comparator | Behavioral: support groupweekly group support class |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- uncomplicated pregnancies starting at 12-26 weeks of gestation
- pregnant women with and without back pain who had no regular yoga practice.
Key exclusion criteria (4 listed)
- significant back pathology
- pregnancy complications
- non-English speaking
- otherwise were not able to participate (eg. transportation, scheduling issues)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yogaonce weekly group yoga class for 12 weeks | Behavioural | yoga |
| support grouponce weekly group support class for 12 weeks | Behavioural | support |
Primary outcome
feasibility of recruitment
Time frame: baseline
recruitment rate
11 secondary outcomes
back pain disability
Time frame: baseline, 4, 8, 12 weeks
back pain severity
Time frame: baseline, 4, 8, 12 weeks
pregnancy symptoms
Time frame: baseline, 4, 8, 12 weeks
depression
Time frame: baseline, 4, 8, 12 weeks
quality of lfe
Time frame: baseline, 4, 8, 12 weeks
childbirth experience
Time frame: postpartum visit
mobility lab- speed
Time frame: baseline, 4, 8, 12 weeks
acceptability
Time frame: 4,8, 12 weeks, postpartum
mobility lab- double support
Time frame: baseline, 4, 8, 12 weeks
mobility lab- TUG
Time frame: baseline, 4, 8, 12 weeks
mobility lab- turn
Time frame: baseline, 4, 8, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Yeh principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yoga and support group in people with Pregnancy Related, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility of recruitment (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.