An interventional study of Reformer pilates exercises in Pregnancy Related, Pelvic Floor Disorders and Pain, Back, sponsored by Izmir Democracy University. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Izmir Democracy University · Not applicable, Interventional, and Supportive care
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.
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.
197 studies on the registry are indexed under Pelvic Floor Disorders; 45 are open to participants now.
This study's planned enrollment of 30 is below the median of 64 across 136 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Izmir Democracy University is the lead sponsor of 73 studies on the registry; 32 are open to participants now.
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Exclusion Criteria:
Reformer pilates sessions will be applied to the participants in the exercise group.
Other: Reformer pilates exercises
Participants in the control group will be recommended to walk.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Neck Pain Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Back Pain Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Low Back Pain Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Pelvic Girdle Pain Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Functional Capacity Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Lumbopelvic Stabilization Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Urinary Incontinence Severity Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Sexual Function Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Diastasis Recti Abdominis Assessment
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.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
Venous Insufficiency Assessment
Participants' venous insufficiency status will be evaluated with the clinical classification subheading of the CEAP classification.
Time frame: First evaluation (baseline) and final evaluation (6 weeks after first evaluation)
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Izmir Democracy University