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Effects of Reformer Pilates in Pregnant Women

The Effects of Reformer Pilates on Pain, Functional Capacity, Lumbopelvic Stabilization, Abdominal Muscles, Respiratory Functions, Pelvic Floor Function, and Venous Insufficiency in Pregnant Women

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06777771
Enrollment
30
Registered
2025-01-16
Start date
2024-02-06
Completion date
2025-09-30
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Back, Pain, Neck, Pelvic Floor Disorders, Pregnancy, Abdominal, Pregnancy Related

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

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.

Interventions

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.

Sponsors

Izmir Democracy University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Exercise group and control group

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Thickness measurement of the rectus abdominis muscleFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
Thickness measurement of the transversus abdominis muscleFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
Thickness measurement of the external oblique abdominal muscleFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
Thickness measurement of the internal oblique abdominal muscleFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
The forced vital capacity (FVC) valueFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
The forced expiratory volume in the first second (FEV1) valueFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
The forced expiratory volume in the first second (FEV1)/the forced vital capacity (FVC) (FEV1/FVC) valueFirst 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 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.
The peak expiratory flow (PEF) valueFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.
Pelvic Floor Dysfunction AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)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.

Secondary

MeasureTime frameDescription
Neck Pain AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)The presence of neck pain will be recorded as present or absent. In the case of pain, the pain intensity will be measured using the Visual Analogue Scale (VAS). In addition, the duration and frequency of pain and activities that reduce or increase pain will be questioned.
Venous Insufficiency AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)Participants' venous insufficiency status will be evaluated with the clinical classification subheading of the CEAP classification.
Back Pain AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)The presence of back pain will be recorded as present or absent. In the case of pain, the pain intensity will be measured using the Visual Analogue Scale (VAS). In addition, the duration and frequency of pain and activities that reduce or increase pain will be questioned.
Low Back Pain AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)The presence of low back pain will be recorded as present or absent. In the case of pain, the pain intensity will be measured using the Visual Analogue Scale (VAS). In addition, the duration and frequency of pain and activities that reduce or increase pain will be questioned.
Pelvic Girdle Pain AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)The presence of pelvic girdle pain will be recorded as present or absent. In the case of pain, the intensity of pain in that area will be measured using the Visual Analogue Scale (VAS). In addition, the duration and frequency of pain and activities that reduce or increase pain will be questioned.
Functional Capacity AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)The functional capacity level of the participants will be evaluated with the five-repetition sit-to-stand test. Participants will be asked to get up and sit down 5 times as quickly as possible. This test will be applied 2 times and the average value will be taken.
Lumbopelvic Stabilization AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)Participants' lumbopelvic stabilization level will be evaluated in the supine position using a pressure-stabilizing feedback device (Pressure Biofeedback Unit, Chattanooga Group, Hixon, TN, USA). The pressure will be adjusted to 40 mmHg. During the test, the abdominal muscles will contract isometrically to keep the lumbar region and pelvis stable, while the load is gradually added with lower extremity movements so that the pressure remains constant. In this test, which consists of five levels, the load acting on the lumbopelvic region is increased with lower extremity movements while progressing from the first level to the fifth level.
Urinary Incontinence Severity AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)Participants' urinary incontinence severity level will be assessed using the Incontinence Severity Index (ISI). A score between 1 and 12 is taken from the ISI. High scores indicate higher urinary incontinence severity.
Sexual Function AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)Participants' sexual function level will be assessed using the Female Sexual Function Index (FSFI). The highest score that may be obtained from the FSFI is 36 and the lowest score is 2. If the score is above 26.5, it means that the sexual function is normal. Values below 26.5 indicate sexual dysfunction.
Diastasis Recti Abdominis AssessmentFirst evaluation (baseline) and final evaluation (6 weeks after first evaluation)Participants will be placed in the supine position. The practitioner's fingers will be vertically on the linea alba. The participant will be asked to raise their head and shoulders off the ground while extending their arms forward. During the measurement, the amount of separation of the two parts of the rectus abdominis muscle will be recorded as the centimeter value of the fingers between the two parts of this muscle. This measurement will be made from the umbilicus, 8-10 cm below and above the umbilicus along the linea alba.

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem Çinar Özdemir, Prof.Dr.
ozlemcinarozdemir@gmail.com+90 232 299 0733
Backup ContactKübra Özonay, PhD student
kubrakaradeniz@gmail.com+90 232 299 0733

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026