ClinicalTrials.gg
CompletedNCT06684002Updated Jul 9, 2025

Effects of Pilates Exercises on Laxity in Pregnant Women

An interventional study of Pilates training and Standard prenatal care and ergonomic advice in Pregnancy, Pilates Exercise and Laxity of Ligament, sponsored by Selcan Suicmez. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-07-09.

Sponsored by Selcan Suicmez · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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. 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.

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.

02

Conditions studied

  • Pregnancy
  • Pilates Exercise
  • Laxity of Ligament

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Keywords

  • pregnancy
  • laxity
  • pilates training
03

In context

Joint Instability

115 studies on the registry are indexed under Joint Instability; 21 are open to participants now.

This study's enrollment of 42 is close to the median of 46 across 58 interventional studies indexed under Joint Instability.

Browse Joint Instability studies →

Lead sponsor

Selcan Suicmez is the lead sponsor of 2 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

  • Aged between 18-35 years
  • In the 14th-16th week of pregnancy
  • Voluntary participation in the study

Exclusion criteria

Exclusion Criteria:

  • Cardiovascular or pulmonary diseases
  • to exercise during pregnancy
  • Prior participation in structured physical activity programs
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

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

Study arms

  • Experimental
    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.

    Other: Pilates training · Other: Standard prenatal care and ergonomic advice

  • Other
    Control Group

    The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training.

    Other: Standard prenatal care and ergonomic advice

Interventions

  • OtherPilates training

    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.

  • OtherStandard prenatal care and ergonomic advice

    The control group received standard prenatal care and ergonomic advice, and did not participate in any exercise training.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes

Secondary outcomes

  1. 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.

    Time frame: 2 minutes

  2. 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.

    Time frame: 7 days

07

Study locations

1 site
  • Ankara Medipol University
    Ankara, Altindag, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2024 to primary completion in Jan 2025, 2 months.

Of 36 non-industry interventional studies with no phase under Joint Instability, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 37. This study's 2 months is below that.

Counting every sponsor, half of 41 studies reached it within 15 months; a quarter within 7 and three quarters within 60.

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

Registered
Nov 9, 2024
First posted
Nov 12, 2024
StartActual
Nov 15, 2024
Primary completionActual
Jan 15, 2025
CompletionActual
Jan 15, 2025
Last update
Jul 9, 2025
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 Jul 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06684002
Lead sponsor
Selcan Suicmez
Collaborators
Gazi University
Responsible party
Selcan Suicmez (Sub-Investigator, Ankara Medipol University) — Sponsor-investigator
First posted
Nov 12, 2024
Start date
Nov 15, 2024
Primary completion
Jan 15, 2025
Completion
Jan 15, 2025
Last update
Jul 9, 2025

Oversight

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

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