Effects of Reformer Pilates in Pregnant Women

NCT06777771 | Recruiting DMC

• 1 other identifier: Reformer pilates in pregnancy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• Thickness measurement of the rectus abdominis muscle

  The thickness of the rectus abdominis muscle will be measured approximately 4 cm lateral to the umbilicus using a 2-7 MHz linear probe (Voluson E8, General Electrics, USA) while participants are lying in a supine position. The measurement will be repeated 3 times, and the average will be recorded in millimeters. The measurements to be made with USG will be made unilaterally by a specialist physician during axial imaging.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Thickness measurement of the transversus abdominis muscle

  The thickness of the transversus abdominis muscle will be measured at the intersection point of the umbilicus and axillary line using a 2-7 MHz linear probe (Voluson E8, General Electrics, USA) while participants are lying in a supine position. The measurement will be repeated 3 times, and the average will be recorded in millimeters. The measurement to be made with USG will be made unilaterally by a specialist physician during axial imaging.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Thickness measurement of the external oblique abdominal muscle

  The thickness of the external oblique abdominal muscle will be measured at the intersection point of the umbilicus and axillary line using a 2-7 MHz linear probe (Voluson E8, General Electrics, USA) while participants are lying in a supine position. The measurement will be repeated 3 times, and the average will be recorded in millimeters. The measurement to be made with USG will be made unilaterally by a specialist physician during axial imaging.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Thickness measurement of the internal oblique abdominal muscle

  The thickness of the internal oblique abdominal muscle will be measured at the intersection point of the umbilicus and axillary line using a 2-7 MHz linear probe (Voluson E8, General Electrics, USA) while participants are lying in a supine position. The measurement will be repeated 3 times, and the average will be recorded in millimeters. The measurement to be made with USG will be made unilaterally by a specialist physician during axial imaging.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• The forced vital capacity (FVC) value

  The forced vital capacity (FVC) value will be measured with a spirometric test using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. During the test, participants will be asked to take a deep breath and then release it as much as possible until there is no air left in their lungs. The test will be repeated 3 times. The average of the two best test results will be recorded.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• The forced expiratory volume in the first second (FEV1) value

  The forced expiratory volume in the first second (FEV1) value will be measured with a spirometric test using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. During the test, participants will be asked to take a deep breath and then release it as much as possible until there is no air left in their lungs. The test will be repeated 3 times. The average of the two best test results will be recorded.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• The forced expiratory volume in the first second (FEV1)/the forced vital capacity (FVC) (FEV1/FVC) value

  The forced expiratory volume in the first second (FEV1)/the forced vital capacity (FVC) (FEV1/FVC) value will be measured with a spirometric test using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. During the test, participants will be asked to take a deep breath and then release it as much as possible until there is no air left in their lungs. The test will be repeated 3 times. The average of the two best test results will be recorded.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• The peak expiratory flow (PEF) value

  The peak expiratory flow (PEF) value will be measured with a spirometric test using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. During the test, participants will be asked to take a deep breath and then release it as much as possible until there is no air left in their lungs. The test will be repeated 3 times. The average of the two best test results will be recorded.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Pelvic Floor Dysfunction Assessment

  Participants' pelvic floor dysfunction value will be assessed using the Pelvic Floor Distress Inventory-20 (PTDE-20). The total score that may be obtained from the PTDE-20 ranges from "0" (best score) to "300" (worst score). High scores indicate higher levels of pelvic floor dysfunction.

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

Secondary Outcomes (10)

• Neck Pain Assessment

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Back Pain Assessment

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Low Back Pain Assessment

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Pelvic Girdle Pain Assessment

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

• Functional Capacity Assessment

  First evaluation (baseline) and final evaluation (6 weeks after first evaluation)

Study Arms (2)

Exercise group

EXPERIMENTAL

Reformer pilates sessions will be applied to the participants in the exercise group.

Other: Reformer pilates exercises

Control group

NO INTERVENTION

Participants in the control group will be recommended to walk.

Interventions

Reformer pilates exercises OTHER

The reformer pilates exercises session will start with 5 minutes of warm-up exercises, continue with resistance exercises for 20 minutes, and end with 5 minutes of cool-down exercises. The springs of the reformer pilates device will be adjusted to create mild fatigue in the first week and will be gradually increased to create moderate fatigue in the following weeks. Reformer pilates sessions will consist of 15-20 different exercises with 12-15 repetitions, including all major muscle groups. These sessions will also include exercises that strengthen the pelvic floor muscles. Reformer pilates sessions will be applied twice a week for 6 weeks, a total of 12 sessions. Apart from this, they will be asked to walk for at least 30 minutes a day, at least 3 days a week.

Exercise group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

İzmir Democracy Univercity

Izmir, Konak, 35140, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• 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.

  PMID: 39593426 BACKGROUND

• 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.

  PMID: 37330773 BACKGROUND

• 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.

  PMID: 36180151 BACKGROUND

• 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.

  PMID: 34839247 BACKGROUND

• 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.

  PMID: 31126153 BACKGROUND

• 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.

  PMID: 28689647 BACKGROUND

• 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.

  PMID: 24268942 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Back Pain; Neck Pain; Pregnancy, Abdominal; Motor Activity; Respiratory Aspiration; Venous Insufficiency; Urinary Incontinence; Pain

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy, Ectopic; Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Vascular Diseases; Cardiovascular Diseases; Urination Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Study Officials

• Özlem Çinar Özdemir, Prof.Dr.

  Izmir Democracy University

  STUDY DIRECTOR

• Kübra Özonay, PhD student

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Özlem Çinar Özdemir, Prof.Dr.

CONTACT

+90 232 299 0733; ozlemcinarozdemir@gmail.com

Kübra Özonay, PhD student

CONTACT

+90 232 299 0733; kubrakaradeniz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: Exercise group and control group

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 16, 2025
• Study Start: February 6, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)