PregnancyNCT06684002
Effects of Pilates Exercises on Laxity in Pregnant Women
A study testing Pilates training and Standard prenatal care and ergonomic advice in people with Pregnancy and Pilates Exercise, run by Selcan Suicmez at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to investigate whether Pilates exercises can help manage musculoskeletal laxity in pregnant women. It will also examine the safety of Pilates exercises during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pregnancy, Pilates Exercise, Laxity of Ligament
- What is being tested?
- Pilates training and Standard prenatal care and ergonomic advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 15 Jan 2025
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-35 years
- In the 14th-16th week of pregnancy
- Voluntary participation in the study
Who cannot join
- Cardiovascular or pulmonary diseases
- Contraindications to exercise during pregnancy
- Prior participation in structured physical activity programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Pilates Exercises on Laxity in Pregnant Women
The goal of this clinical trial is to investigate whether Pilates exercises can help manage musculoskeletal laxity in pregnant women. It will also examine the safety of Pilates exercises during pregnancy. The primary questions this trial aims to answer are:
Does Pilates exercise reduce the level of laxity in pregnant women? What physical issues do participants experience while performing Pilates exercises during pregnancy?
Read more
Participants will:
Engage in Pilates exercises tailored for pregnancy, under the supervision of trained physiotherapists, for a period of 8 weeks.
Attend monthly checkups to monitor progress and record physical health changes. The intention is to determine whether Pilates exercises are effective in improving joint stability and reducing the laxity caused by hormonal changes during pregnancy.
Read the detailed description
Pregnancy is a physiological process that lasts approximately 40 weeks, during which the embryo completes its development, from fertilization to birth. During this process, significant changes occur in the mother's anatomy, physiology, psychology, and social aspects to maintain maternal homeostasis and ensure optimal fetal growth. The changes during pregnancy are due to four main factors: hormonal-induced changes in collagen tissue and smooth muscle, increased blood volume to enhance circulation to the uterus and kidneys, expansion and displacement of the uterus due to fetal growth, and, lastly, changes in the center of gravity and posture due to weight gain and adaptations. As a result of these changes, pregnant women may experience increases in body weight, ligament laxity, and lumbar lordosis, as well as a decrease in neuromuscular control and abdominal muscle strength, changes in body biomechanics, and a forward shift in the center of gravity. These changes significantly affect the musculoskeletal system, particularly women's bodies. If the body does not adapt to these changes appropriately, potential health problems that threaten the mother's and fetus's health may arise.
Studies have shown that hormonal changes play a role in musculoskeletal system changes from the very beginning of pregnancy. Estrogen, progesterone, endogenous cortisol, and relaxin hormones play significant roles in these changes. Relaxin levels increase until the 12th week of pregnancy, decrease until the 17th week, and stabilize. The increase in relaxin causes tissue relaxation, leading to increased mobility and instability of the pelvic complex and peripheral joints. Estrogen increases in the third trimester and alters bone, cartilage, and ligament structure. Progesterone peaks in the 15th week and induces relaxation effects on muscle structures. These hormonal changes cause physiological relaxation of the pelvic ligaments to facilitate the passage of the fetus through the birth canal. Due to increased levels of relaxin and progesterone, weakened abdominal muscles and an expanding abdomen result in muscle stretching. All of these lead to postural changes, dysfunction in the lumbar and pelvic regions, and weakness in the abdominal muscles. Studies have highlighted that musculoskeletal disorders and increased pain in various joints, such as the knee, observed during pregnancy may be related to laxity.
Regular physical activity has significant benefits for pregnancies that are not complicated by medical or obstetric issues and are classified as low-risk. Therefore, increasing the level of physical activity during pregnancy and performing regular exercises are recommended by the American College of Obstetricians and Gynecologists in their guidelines for physical activity and exercise during pregnancy and the postpartum period. The benefits of regular physical activity and exercise during pregnancy include maintaining and improving physical fitness, preventing excessive gestational weight gain, reducing the risk of pre-eclampsia and preterm birth, decreasing the prevalence of back pain, improving sleep quality, reducing anxiety and depressive symptoms, and enhancing health perception and body image. Due to these beneficial effects, engaging in at least 30 minutes of moderate aerobic exercise five days a week is recommended. However, it has been reported that approximately 15% of women during pregnancy meet the minimum physical activity recommendation (at least 150 minutes of moderate physical activity per week).
Pilates is an exercise method developed by Joseph Hubertus Pilates that activates all the muscular functions of the body, increasing the endurance, flexibility, and strength of all body muscles, particularly the core, and improving balance systems. It also enhances dynamic postural control. The core is the center of the kinetic chain and is responsible for power transfer between the upper and lower body. All movements begin with the contraction of the muscles in the core, and the power generated by these contractions is transferred to the limbs. The core muscles are described as an anatomical box comprising several muscle groups. Over time, the demand for physical therapy to develop the core has increased. Pilates and core exercises, which have proven effectiveness, are among the interventions used for this purpose.
Joseph Pilates, who developed over 600 exercises suitable for various levels and body types, aimed to improve the stabilization of the core muscles-multifidus, transversus abdominis, pelvic floor, and diaphragm muscles, which represent the powerhouse in Pilates-and to improve the strength, endurance, and flexibility of the muscles, ligaments, and fascia that transmit the power generated by these muscles throughout the body, thus promoting overall body health.
Craig Phillips, a physiotherapist and former ballet dancer, led the establishment of the Australian Physiotherapy and Pilates Institute (APPI) and worked to modify Pilates exercises to be more suitable for body biomechanics. Today, modified Pilates, performed by physiotherapists, has emerged as clinical Pilates. This allows physiotherapists to apply Pilates exercise programs tailored to individuals based on clinical Pilates and scientific foundation principles, including for pregnant women.
Clinical Pilates positively affects both maternal health and the health of the fetus. Clinical Pilates is adequate during pregnancy in controlling breathing, improving spinal stabilization, pelvic floor control, and developing proper posture. It also increases muscle tone and strength. Strengthened and developed muscles improve women's activity levels, coordination, and balance. Those who practice Pilates daily experience increased energy throughout the day. Pilates during pregnancy helps restore the balance sense disturbed by postural and hormonal changes, increases joint range of motion and flexibility, and improves strength. It allows women to adapt more comfortably to the temporary body changes that come with pregnancy and move freely with their bodies. Therefore, clinical Pilates is considered an ideal form of exercise for pregnancy.
Considering the changes occurring during pregnancy and the positive effects of Pilates exercises on body systems during pregnancy, it is thought that the effect of Pilates exercises on laxity in pregnant women should be investigated. Therefore, the aim of our study is to examine the effect of the Pilates exercise method on laxity.
In line with our objectives, our hypotheses are as follows:
H0: Pilates exercises have no effect on laxity in pregnant women. H1: Pilates exercises have an effect on laxity in pregnant women.
- Conditions
- Pregnancy, Pilates Exercise, Laxity of Ligament
- Being tested
- Pilates training, Standard prenatal care and ergonomic advice
- Keywords
- pregnancy, laxity, pilates training
- Medical subject headings
- Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates trainingOther
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.
Standard prenatal care and ergonomic adviceOther
The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | 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. Receives: Other: Pilates training; Other: Standard prenatal care and ergonomic advice |
| Control Group | Other | The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training. Receives: Other: Standard prenatal care and ergonomic advice |
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 posted12 Nov 2024
- Study start15 Nov 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
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 PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcan Suicmez
- Sponsor type
- University, hospital or other
- Collaborators
- Gazi University
- Responsible party
- Sponsor-investigator, Selcan Suicmez, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684002
- Sponsor's protocol ID
- AnkaraMedipolU-FTR-2024-128
- Status last verified
- Jul 2025
- First submitted
- 9 Nov 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bulguroglu M, Bulguroglu HI, Degirmenci B, Suicmez S, Gevrek Aslan C, Zorlu Develik S, Atalay Guzel N. Effectiveness of a prenatal pilates program on ligamentous laxity and joint hypermobility in pregnant women: a dual-center randomized controlled trial. BMC Pregnancy Childbirth. 2025 Aug 28;25(1):897. doi: 10.1186/s12884-025-08082-1.
PubMed 40877820
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Pilates Exercises on Laxity in Pregnant Women
- ClinicalTrials.gov ID
- NCT06684002
- Acronym / sponsor ID
- AnkaraMedipolU-FTR-2024-128
- Conditions
- Pregnancy, Pilates Exercise, Laxity of Ligament
- Keywords
- pregnancy, laxity, pilates training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Selcan SuicmezUniversity, hospital or other
- Collaborators
- Gazi University
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 12 Nov 2024 (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.
The goal of this clinical trial is to investigate whether Pilates exercises can help manage musculoskeletal laxity in pregnant women. It will also examine the safety of Pilates exercises during pregnancy. The primary questions this trial aims to answer are:
Does Pilates exercise reduce the level of laxity in pregnant women? What physical issues do participants experience while performing Pilates exercises during pregnancy?
Participants will:
Engage in Pilates exercises tailored for pregnancy, under the supervision of trained physiotherapists, for a period of 8 weeks.
Attend monthly checkups to monitor progress and record physical health changes. The intention is to determine whether Pilates exercises are effective in improving joint stability and reducing the laxity caused by hormonal changes during pregnancy.
Detailed description
Pregnancy is a physiological process that lasts approximately 40 weeks, during which the embryo completes its development, from fertilization to birth. During this process, significant changes occur in the mother's anatomy, physiology, psychology, and social aspects to maintain maternal homeostasis and ensure optimal fetal growth. The changes during pregnancy are due to four main factors: hormonal-induced changes in collagen tissue and smooth muscle, increased blood volume to enhance circulation to the uterus and kidneys, expansion and displacement of the uterus due to fetal growth, and, lastly, changes in the center of gravity and posture due to weight gain and adaptations. As a result of these changes, pregnant women may experience increases in body weight, ligament laxity, and lumbar lordosis, as well as a decrease in neuromuscular control and abdominal muscle strength, changes in body biomechanics, and a forward shift in the center of gravity. These changes significantly affect the musculoskeletal system, particularly women's bodies. If the body does not adapt to these changes appropriately, potential health problems that threaten the mother's and fetus's health may arise.
Studies have shown that hormonal changes play a role in musculoskeletal system changes from the very beginning of pregnancy. Estrogen, progesterone, endogenous cortisol, and relaxin hormones play significant roles in these changes. Relaxin levels increase until the 12th week of pregnancy, decrease until the 17th week, and stabilize. The increase in relaxin causes tissue relaxation, leading to increased mobility and instability of the pelvic complex and peripheral joints. Estrogen increases in the third trimester and alters bone, cartilage, and ligament structure. Progesterone peaks in the 15th week and induces relaxation effects on muscle structures. These hormonal changes cause physiological relaxation of the pelvic ligaments to facilitate the passage of the fetus through the birth canal. Due to increased levels of relaxin and progesterone, weakened abdominal muscles and an expanding abdomen result in muscle stretching. All of these lead to postural changes, dysfunction in the lumbar and pelvic regions, and weakness in the abdominal muscles. Studies have highlighted that musculoskeletal disorders and increased pain in various joints, such as the knee, observed during pregnancy may be related to laxity.
Regular physical activity has significant benefits for pregnancies that are not complicated by medical or obstetric issues and are classified as low-risk. Therefore, increasing the level of physical activity during pregnancy and performing regular exercises are recommended by the American College of Obstetricians and Gynecologists in their guidelines for physical activity and exercise during pregnancy and the postpartum period. The benefits of regular physical activity and exercise during pregnancy include maintaining and improving physical fitness, preventing excessive gestational weight gain, reducing the risk of pre-eclampsia and preterm birth, decreasing the prevalence of back pain, improving sleep quality, reducing anxiety and depressive symptoms, and enhancing health perception and body image. Due to these beneficial effects, engaging in at least 30 minutes of moderate aerobic exercise five days a week is recommended. However, it has been reported that approximately 15% of women during pregnancy meet the minimum physical activity recommendation (at least 150 minutes of moderate physical activity per week).
Pilates is an exercise method developed by Joseph Hubertus Pilates that activates all the muscular functions of the body, increasing the endurance, flexibility, and strength of all body muscles, particularly the core, and improving balance systems. It also enhances dynamic postural control. The core is the center of the kinetic chain and is responsible for power transfer between the upper and lower body. All movements begin with the contraction of the muscles in the core, and the power generated by these contractions is transferred to the limbs. The core muscles are described as an anatomical box comprising several muscle groups. Over time, the demand for physical therapy to develop the core has increased. Pilates and core exercises, which have proven effectiveness, are among the interventions used for this purpose.
Joseph Pilates, who developed over 600 exercises suitable for various levels and body types, aimed to improve the stabilization of the core muscles-multifidus, transversus abdominis, pelvic floor, and diaphragm muscles, which represent the powerhouse in Pilates-and to improve the strength, endurance, and flexibility of the muscles, ligaments, and fascia that transmit the power generated by these muscles throughout the body, thus promoting overall body health.
Craig Phillips, a physiotherapist and former ballet dancer, led the establishment of the Australian Physiotherapy and Pilates Institute (APPI) and worked to modify Pilates exercises to be more suitable for body biomechanics. Today, modified Pilates, performed by physiotherapists, has emerged as clinical Pilates. This allows physiotherapists to apply Pilates exercise programs tailored to individuals based on clinical Pilates and scientific foundation principles, including for pregnant women.
Clinical Pilates positively affects both maternal health and the health of the fetus. Clinical Pilates is adequate during pregnancy in controlling breathing, improving spinal stabilization, pelvic floor control, and developing proper posture. It also increases muscle tone and strength. Strengthened and developed muscles improve women's activity levels, coordination, and balance. Those who practice Pilates daily experience increased energy throughout the day. Pilates during pregnancy helps restore the balance sense disturbed by postural and hormonal changes, increases joint range of motion and flexibility, and improves strength. It allows women to adapt more comfortably to the temporary body changes that come with pregnancy and move freely with their bodies. Therefore, clinical Pilates is considered an ideal form of exercise for pregnancy.
Considering the changes occurring during pregnancy and the positive effects of Pilates exercises on body systems during pregnancy, it is thought that the effect of Pilates exercises on laxity in pregnant women should be investigated. Therefore, the aim of our study is to examine the effect of the Pilates exercise method on laxity.
In line with our objectives, our hypotheses are as follows:
H0: Pilates exercises have no effect on laxity in pregnant women. H1: Pilates exercises have an effect on laxity in pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates training, Other: Standard prenatal care and ergonomic adviceParticipants 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 | Other | Other: Standard prenatal care and ergonomic adviceThe 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
Key inclusion criteria (3 listed)
- Aged between 18-35 years
- In the 14th-16th week of pregnancy
- Voluntary participation in the study
Key exclusion criteria (3 listed)
- Cardiovascular or pulmonary diseases
- Contraindications to exercise during pregnancy
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates trainingParticipants 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. | Other | Pilates Group |
| Standard prenatal care and ergonomic adviceThe control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training. | Other | Control Group, Pilates Group |
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 9 Jul 2025.
- Derived from this study: PubMed 40877820Bulguroglu M, Bulguroglu HI, Degirmenci B, Suicmez S, Gevrek Aslan C, Zorlu Develik S, Atalay Guzel N. Effectiveness of a prenatal pilates program on ligamentous laxity and joint hypermobility in pregnant women: a dual-center randomized controlled trial. BMC Pregnancy Childbirth. 2025 Aug 28;25(1):897. doi: 10.1186/s12884-025-08082-1.
- 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?
A study testing Pilates training and Standard prenatal care and ergonomic advice in people with Pregnancy and Pilates Exercise, run by Selcan Suicmez 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 3 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 9 Jul 2025. 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 NCT06684002, 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 9 Jul 2025.