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临床试验/NCT06777771
NCT06777771招募中不适用

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

Izmir Democracy University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年2月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
The forced vital capacity (FVC) value

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Exercise group

Experimental

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

干预措施: Reformer pilates exercises (Other)

Control group

No Intervention

Participants in the control group will be recommended to walk.

结局指标

主要结局

The forced vital capacity (FVC) value

时间窗: First 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.

Thickness measurement of the rectus abdominis muscle

时间窗: First 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 muscle

时间窗: First 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 muscle

时间窗: First 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 muscle

时间窗: First 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 expiratory volume in the first second (FEV1) value

时间窗: First 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) value

时间窗: 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 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) value

时间窗: First 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 Assessment

时间窗: First 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.

次要结局

  • 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))
  • Lumbopelvic Stabilization Assessment(First evaluation (baseline) and final evaluation (6 weeks after first evaluation))
  • Urinary Incontinence Severity Assessment(First evaluation (baseline) and final evaluation (6 weeks after first evaluation))
  • Sexual Function Assessment(First evaluation (baseline) and final evaluation (6 weeks after first evaluation))
  • Venous Insufficiency Assessment(First evaluation (baseline) and final evaluation (6 weeks after first evaluation))
  • Diastasis Recti Abdominis Assessment(First evaluation (baseline) and final evaluation (6 weeks after first evaluation))

研究者

发起方
Izmir Democracy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Çınar Özdemir

Assoc. Prof.

Izmir Democracy University

研究点 (1)

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