Clinical trial NCT06777771: Effects of Reformer Pilates in Pregnant Women
Official title: The Effects of Reformer Pilates on Pain, Functional Capacity, Lumbopelvic Stabilization, Abdominal Muscles, Respiratory Functions, Pelvic Floor Function, and Venous Insufficiency in Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Pelvic Floor Disorders
Pain, Back
Pain, Neck
Pregnancy, Abdominal
Keywords: Pregnancy
Exercise
Reformer Pilates
Pilates
Pelvic Floor Dysfunction
Lumbopelvic Stabilization
Functional Capacity
Respiratory Function
Abdominal Muscle Thickness
Venous Insufficiency
Urinary Incontinence
Sexual Function
Pain
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Exercise group and control group
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pregnancy is known as a period associated with important physiological and psychological changes in women's lives. There is moderately sufficient evidence in the literature to recommend supplementing prenatal physical activity for maternal health benefits. It has been reported that physical exercise by pregnant women in the absence of obstetric contraindications will not pose a risk to the health of the mother and fetus. In the literature, there are no studies examining the effects of reformer pilates on pain, functional capacity, lumbopelvic stabilization, diastasis recti abdominis, abdominal muscle thickness, respiratory functions, pelvic floor dysfunction, urinary incontinence, sexual function, and venous insufficiency in pregnant women. Therefore, this study aimed to investigate the effects of reformer pilates on pain, functional capacity, lumbopelvic stabilization, diastasis recti abdominis, abdominal muscle thickness, respiratory functions, pelvic floor dysfunction, urinary incontinence, sexual function, and venous insufficiency in pregnant women.

Detailed description: Pregnancy is one of the most serious periods in a woman's life and lasts approximately forty weeks. Many anatomical, physiological, and psychological changes occur in pregnant women. The main reasons for these are hormonal changes, increase in total blood volume, growth of the uterus, and postural changes due to the shift of the body's center of gravity.

Even though the etiology and pathogenesis of low back pain occurring during pregnancy have not been clearly explained, it is assumed to be multifactorial. Low back pain during pregnancy is common and affects approximately half of pregnant women. Additionally, pain may occur in the low back and sacroiliac joints due to postural changes that occur with the growth of the fetus. Low back pain and pelvic girdle pain are among the most common musculoskeletal complaints in pregnant women.

Studies conducted on pregnant women and women in the postpartum period have reported changes in the length, thickness, and separation amount of the abdominal muscles and the morphological features of the rectus abdominis muscle.

The strength and thickness of the pelvic floor muscles may decrease in pregnant women. Pregnancy and birth are major risk factors for urinary incontinence. Additionally, a relationship between pregnancy and sexual dysfunction has been reported in the literature.

To meet the needs of the fetus during pregnancy, changes occur in many organs and systems, as well as changes in the uterus. One of these is the adaptation seen in the respiratory system. Another change is the adaptation in the venous system. Pregnancy is one of the factors that increase the risk of developing venous insufficiency.

Pregnancy is known as a period associated with important physiological and psychological changes in women's lives. Pregnancy and exercise are biological processes. These cause many adaptations in the body, which may be in the same or the opposite direction. There is moderately sufficient evidence in the literature to recommend promoting prenatal physical activity for maternal health benefits.

In the literature, no study has been found investigating the effects of reformer pilates on pain, functional capacity, lumbopelvic stabilization, diastasis recti abdominis, abdominal muscle thickness, respiratory functions, pelvic floor dysfunction, urinary incontinence, sexual function, and venous insufficiency in pregnant women. For this reason, this study aimed to investigate the effects of reformer pilates on pain, functional capacity, lumbopelvic stabilization, diastasis recti abdominis, abdominal muscle thickness, respiratory functions, pelvic floor dysfunction, urinary incontinence, sexual function, and venous insufficiency in pregnant women.

Eligibility criteria: Inclusion Criteria:

* Single pregnancy
* Primiparous pregnancy
* Adult pregnant women (between 18-35 years old)
* Pregnant women whose gestational week is 11-22 weeks
* Pregnant women with a body mass index \<30
* Ability to read and write

Exclusion Criteria:

* Multiple pregnancies
* Having a history of abdominal surgery
* Having one of the conditions in which exercise is contraindicated, such as heart disease, severe lung disease, continuous bleeding in the second and third trimesters, placenta previa, risk of premature birth, rupture of membranes, preeclampsia, severe anemia
* Not volunteering to participate in the study
* Not participating in more than 90% of the training sessions

Primary outcomes:
measure: Thickness measurement of the rectus abdominis muscle
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Thickness measurement of the transversus abdominis muscle
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Thickness measurement of the external oblique abdominal muscle
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Thickness measurement of the internal oblique abdominal muscle
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: The forced vital capacity (FVC) value
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: The forced expiratory volume in the first second (FEV1) value
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: The forced expiratory volume in the first second (FEV1)/the forced vital capacity (FVC) (FEV1/FVC) value
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: The peak expiratory flow (PEF) value
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Pelvic Floor Dysfunction Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Secondary outcomes:
measure: Neck Pain Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Back Pain Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Low Back Pain Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Pelvic Girdle Pain Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Functional Capacity Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Lumbopelvic Stabilization Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Urinary Incontinence Severity Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Sexual Function Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Diastasis Recti Abdominis Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
measure: Venous Insufficiency Assessment
timeFrame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İzmir Democracy Univercity
state: Konak
Study officials:
affiliation: Izmir Democracy University
name: Özlem Çinar Özdemir, Prof.Dr.
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: Kübra Özonay, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bilchinsky T, Tene L, Kalichman L. Pilates exercises during pregnancy: A narrative review. J Bodyw Mov Ther. 2024 Oct;40:1146-1152. doi: 10.1016/j.jbmt.2024.07.038. Epub 2024 Jul 18.
citation: Ferraz VS, Peixoto C, Ferreira Resstel AP, Cerqueira de Paula YT, Gomes de Souza Pegorare AB. Effect of the pilates method on pain and quality of life in pregnancy: A systematic review and meta-analysis. J Bodyw Mov Ther. 2023 Jul;35:220-227. doi: 10.1016/j.jbmt.2023.04.076. Epub 2023 May 3.
citation: Mazzarino M, Kerr D, Morris ME. Feasibility of pilates for pregnant women: A randomised trial. J Bodyw Mov Ther. 2022 Oct;32:207-212. doi: 10.1016/j.jbmt.2022.05.001. Epub 2022 May 8.
citation: Von Aarburg N, Veit-Rubin N, Boulvain M, Bertuit J, Simonson C, Desseauve D. Physical activity and urinary incontinence during pregnancy and postpartum: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2021 Dec;267:262-268. doi: 10.1016/j.ejogrb.2021.11.005. Epub 2021 Nov 16.
citation: Chan CWH, Au Yeung E, Law BMH. Effectiveness of Physical Activity Interventions on Pregnancy-Related Outcomes among Pregnant Women: A Systematic Review. Int J Environ Res Public Health. 2019 May 23;16(10):1840. doi: 10.3390/ijerph16101840.
citation: Rodriguez-Diaz L, Ruiz-Frutos C, Vazquez-Lara JM, Ramirez-Rodrigo J, Villaverde-Gutierrez C, Torres-Luque G. Effectiveness of a physical activity programme based on the Pilates method in pregnancy and labour. Enferm Clin. 2017 Sep-Oct;27(5):271-277. doi: 10.1016/j.enfcli.2017.05.008. Epub 2017 Jul 6. English, Spanish.
citation: Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.