Laxity of LigamentNCT07344857
Prenatal Pilates and Postpartum Ligamentous Laxity
An observational study of Laxity of Ligament and Pregnancy, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy induces hormonal and biomechanical adaptations that increase ligamentous laxity, which may persist into the postpartum period and contribute to joint instability, pain, and functional limitations. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Laxity of Ligament, Pregnancy, Pilates Exercise
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2025to 15 Jan 2026
- Phase
- Observational
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consisted of postpartum women aged 18-35 years who were 6th week after delivery and who voluntarily agreed to participate in the study. Women with known cardiovascular or pulmonary diseases, and those who had participated in structured physical activity programs prior to enrollment were excluded. These criteria were applied to ensure a homogeneous sample and to minimize potential confounding factors related to pre-existing health conditions or prior exercise exposure.
Who may be able to join
- Aged between 18-35 years
- In the 6th week of post-partum
- Voluntary participation in the study
Who cannot join
- Cardiovascular or pulmonary diseases
- Prior participation in structured physical activity programs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Medipol University
Ankara, Altındağ, 06050
About this study
Official title: Impact of a Prenatal Pilates Program Continued Until Childbirth on Postpartum Ligamentous Recovery: a Longitudinal Follow-up of a Randomized Controlled Trial
Pregnancy induces hormonal and biomechanical adaptations that increase ligamentous laxity, which may persist into the postpartum period and contribute to joint instability, pain, and functional limitations. Although prenatal Pilates has been shown to prevent the progression of ligamentous laxity during pregnancy, its effects on postpartum musculoskeletal recovery remain unclear. This longitudinal follow-up of a randomized controlled trial evaluated ligamentous recovery at 6 weeks postpartum in women who participated in a structured prenatal Pilates program continued until childbirth, compared with women receiving standard prenatal care. Postpartum ligamentous laxity, generalized joint hypermobility, and activity limitations related to pelvic girdle pain were assessed using objective and clinical measures. The study aimed to determine whether prenatal Pilates facilitates early postpartum ligamentous recovery and supports functional outcomes during the early postpartum period.
- Conditions
- Laxity of Ligament, Pregnancy, Pilates Exercise
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Participants in the Pilates group attended supervised 60-minute sessions twice weekly for eight weeks, led by a certified physiotherapist trained by the Australian Institute of Pilates and Physiotherapy. | |
| Control Group | The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ligament laxity
The anterior tibial translation of the knee will be considered as representative of the anterior laxity of the knee of women measured with an arthrometer ® (bilateral examination repeated 3 times on each knee).The degree of laxity will be evaluated thanks to the international classification IKDC.
Measured: 10 minutes
Secondary outcomes (2)
Generalized joint hypermobility
Generalized joint hypermobility (GJH) was assessed using the Beighton scoring system, which consists of five bilateral and unilateral maneuvers. Each positive test scored one point, with a maximum score of 9. A score of ≥5 indicated GJH.
Measured: 2 minutes
Physical activity level
Participants' physical activity was monitored using the Omron HJ-321-E pedometer (Omron Healthcare, Japan), which detects vertical oscillations and stores up to seven days of data.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start20 Nov 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laxity of LigamentStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Suicmez, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344857
- Sponsor's protocol ID
- AnkaraMedipolU-FTR-2025-223
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulguroglu HI, Bulguroglu M, Degirmenci B, Suicmez S, Aslan CG, Develik SZ, Atalay Guzel N. Effect of continued prenatal Pilates until childbirth on postpartum ligamentous recovery: a longitudinal follow-up of a randomized controlled trial. BMC Pregnancy Childbirth. 2026 May 1;26(1):663. doi: 10.1186/s12884-026-09183-1.
PubMed 42067815
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Prenatal Pilates Program Continued Until Childbirth on Postpartum Ligamentous Recovery: a Longitudinal Follow-up of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07344857
- Acronym / sponsor ID
- AnkaraMedipolU-FTR-2025-223
- Conditions
- Laxity of Ligament, Pregnancy, Pilates Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 20 Nov 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 15 Jan 2026 (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.
Pregnancy induces hormonal and biomechanical adaptations that increase ligamentous laxity, which may persist into the postpartum period and contribute to joint instability, pain, and functional limitations. Although prenatal Pilates has been shown to prevent the progression of ligamentous laxity during pregnancy, its effects on postpartum musculoskeletal recovery remain unclear. This longitudinal follow-up of a randomized controlled trial evaluated ligamentous recovery at 6 weeks postpartum in women who participated in a structured prenatal Pilates program continued until childbirth, compared with women receiving standard prenatal care. Postpartum ligamentous laxity, generalized joint hypermobility, and activity limitations related to pelvic girdle pain were assessed using objective and clinical measures. The study aimed to determine whether prenatal Pilates facilitates early postpartum ligamentous recovery and supports functional outcomes during the early postpartum period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | – | –Participants in the Pilates group attended supervised 60-minute sessions twice weekly for eight weeks, led by a certified physiotherapist trained by the Australian Institute of Pilates and Physiotherapy. |
| Control Group | – | –The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of postpartum women aged 18-35 years who were 6th week after delivery and who voluntarily agreed to participate in the study. Women with known cardiovascular or pulmonary diseases, and those who had participated in structured physical activity programs prior to enrollment were excluded. These criteria were applied to ensure a homogeneous sample and to minimize potential confounding factors related to pre-existing health conditions or prior exercise exposure.
Key inclusion criteria (3 listed)
- Aged between 18-35 years
- In the 6th week of post-partum
- Voluntary participation in the study
Key exclusion criteria (2 listed)
- Cardiovascular or pulmonary diseases
- Prior participation in structured physical activity programs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ligament laxity
Time frame: 10 minutes
The anterior tibial translation of the knee will be considered as representative of the anterior laxity of the knee of women measured with an arthrometer ® (bilateral examination repeated 3 times on each knee).The degree of laxity will be evaluated thanks to the international classification IKDC.
2 secondary outcomes
Generalized joint hypermobility
Time frame: 2 minutes
Physical activity level
Time frame: 7 days
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 22 Jan 2026.
- Derived from this study: PubMed 42067815Bulguroglu HI, Bulguroglu M, Degirmenci B, Suicmez S, Aslan CG, Develik SZ, Atalay Guzel N. Effect of continued prenatal Pilates until childbirth on postpartum ligamentous recovery: a longitudinal follow-up of a randomized controlled trial. BMC Pregnancy Childbirth. 2026 May 1;26(1):663. doi: 10.1186/s12884-026-09183-1.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laxity of Ligament and Pregnancy, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
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 3 inclusion and 2 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 22 Jan 2026. 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 Turkey (Türkiye). 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?
Ligament laxity (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07344857, which also lists 1 linked publication.
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 22 Jan 2026.