The Impact of Dynamic Neuromuscular Stabilization on Pregnancy

Exercise Clinical Trial

Official title:

The Effect of Dynamic Neuromuscular Stabilization Applied in the Second Trimester of Pregnancy on Pregnancy: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06239753
• Other study ID #: KLKSH
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2, 2024
• Est. completion date: July 2, 2025

Study information

• Verified date: April 2024
• Source: Lütfi Kirdar City Hospital
• Contact: Döndü Kurnaz, Dr
• Phone: 5052381105
• Email: zsk2001[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this randomized controlled study is to determine the pregnancy and childbirth outcomes of using the DNS method to facilitate anatomical and physiological adaptations during pregnancy.

Description:

During pregnancy, significant anatomical and physiological changes occur as the baby grows inside the uterus. As pregnancy progresses, body mass index increases, the uterus expands towards the abdominal cavity, and the woman's center of gravity shifts. This change in the center of gravity leads to a backward shift in the trunk, hyperextension of the knees, and the formation of lumbar lordosis, thoracic kyphosis, and pelvic curvature. The increased weight can cause pelvic floor collapse and weakness in pelvic floor muscles, leading to urinary incontinence, pelvic organ prolapse, fecal incontinence, sexual dysfunction, and pelvic pain. Proper management of the body during this period can not only facilitate childbirth but also reduce potential problems that may arise during pregnancy. Exercises play a crucial role in managing the body correctly during pregnancy. Aerobic exercises, strength training, and specific Kegel exercises are commonly performed during pregnancy. However, despite the frequent occurrence of musculoskeletal and postural changes during pregnancy, it is observed that postural exercises to regulate these changes are not widely implemented. Studies have indicated that stabilization exercises are more effective than traditional strength exercises in reducing complaints during pregnancy. There is a lack of sufficient research in the literature on core stabilization related to posture alignment during pregnancy. Core stabilization is defined as the ability to control the position and movement of the trunk on the pelvis to allow optimal force production, transfer, and movement of the extremities. It is essential to prevent excessive load on the pelvis, spine, and kinetic chain. When this system functions effectively, loads on the body are distributed evenly, reducing excess load on the joints of the kinetic chain. Core strength training primarily focuses on strengthening deep core muscles, especially the multifidus and transversus abdominis muscles, which may weaken during pregnancy. Current exercise programs for pregnant women include exercises targeting core muscles, such as Pilates, antigravity fitness, birth support belts, stability balls, and Dynamic Neuromuscular Stabilization (DNS). Although studies on the benefits of stabilization exercises during pregnancy are available in the literature, there is no specific research on the application of DNS during pregnancy. DNS is a system that emphasizes coordination and strength, focusing on the overall harmony of the body and foundational stability. It is based on developmental kinesiology models. DNS encompasses motor patterns and programs that infants inherently possess, allowing them to develop ideal posture, functional joint centering, optimal respiration, and locomotor skills during ontogenesis. The main goal is to restore physiological movement patterns defined by developmental kinesiology DNS has been widely accepted in clinical practice as a method that provides balanced subcortical or reflexive core stabilization, coordinating diaphragm, transversus abdominis, internal oblique, multifidus, and pelvic floor coactivation with intra-abdominal pressure and coordinated activation of superficial abdominal muscles. Understanding the physiological and anatomical adaptations during pregnancy is crucial for the pregnant woman to cope with the increased metabolic demands vital for the developing fetus and meet the requirements of childbirth. Recognizing pathological deviations in pregnant women and ensuring core stabilization using appropriate methods are essential to optimize outcomes for both the mother and the baby. In the context of critically ill pregnant women, the DNS method can be used effectively during pregnancy, taking into account that different modifications may be needed to optimize their treatment. Well-designed studies are needed to determine the effectiveness of the DNS method.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: July 2, 2025
• Est. primary completion date: January 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

Primiparity

• Singleton Pregnancy
• Gestational Age Between 11-13 Weeks
• Age Between 20-35 Years
• Body Mass Index in the Range of 18-30
• Receiving Pregnancy Check-ups at the Hospital where the Research is Conducted

Exclusion Criteria:

• Presence of a heart condition affecting hemodynamics
• History of restrictive lung disease
• Multiple pregnancies
• Severe anemia
• Movement-restricting musculoskeletal system anomalies

Related Conditions & MeSH terms

• Exercise
• Pregnant

Intervention

Behavioral:
• Dynamic Neuromuscular Stabilization
Conducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes. Application of Dynamic Neuromuscular Stabilization (DNS).
• Standard Prenatal Education Program Implementation
Conducting routine pregnancy examinations. Measurement of pelvic floor muscle dimensions. Providing education through prenatal classes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dondu Kurnaz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pelvic Floor Muscle Measurements	Pelvic floor muscle measurements will be assessed by a specialist in obstetrics and gynecology using transperineal ultrasonography. The Voluson 730 Pro ultrasound device will be used for assessment. A standard bladder filling protocol will be implemented before measurements. For this, women will be instructed to drink 600-750 ml of water one hour before the evaluation and refrain from emptying their bladders until the end of the test. Women will be positioned on their backs with knees flexed at 60°, and a pillow will be placed under their head. The ultrasound transducer will be placed suprapubically in the caudo-posterior direction to visualize the posterior inferior aspect of the bladder in the transverse plane during the first rest period. A first marker will be placed at the base of the bladder during this resting period. Women will be asked to contract their pelvic floor muscles during the assessment. The ultrasound image will be frozen during this contraction, and a second marker	Between the 11th and 36th weeks of pregnancy,
Primary	The Pittsburgh Sleep Quality Index	Assessing sleep quality over the past month, the PSQI consists of a total of 24 questions. The total score ranges from 0 to 21. A total score higher than 5 indicates poor sleep quality. The scale will be applied twice, for the first and last application.	Between the 11th and 36th weeks of pregnancy,
Primary	State-Trait Anxiety Inventory	Aims to measure individuals' levels of state and trait anxiety. The scale consists of two subscales, each comprising 20 items. An increase in scores from the scale indicates a higher level of anxiety. The scale will be applied twice, for the first and last application. The total score obtained from the scale varies between 20 and 80. A large score indicates a high level of anxiety, and a small score indicates a low level of anxiety. The average score level determined in the applications varies between 36 and 41.	Between the 11th and 36th weeks of pregnancy,
Primary	Oswestry Skalasi	The questionnaire related to lower back pain consisting of a total of 10 questions, each with 6 options. The scale assigns a minimum score of 0 and a maximum score of 5 to each question. The overall possible score ranges from 0 to 50. An increase in the total score collected from the questionnaire indicates a worsening of the pain condition. The scale will be applied twice, for the first and last application.	Between the 11th and 36th weeks of pregnancy,
Primary	Multidimensional Scale of Perceived Social Support	The questionnaire based on the subjective evaluation of social support received from family, friends, and significant others in individuals' social environments. The questionnaire examines three dimensions: family, friends, and significant others, totaling 48 questions with four questions evaluating each dimension. Each item in the scale is rated on a 7-point Likert scale ranging from strongly disagree to strongly agree. Scores obtained from the three separate dimensions are summed to calculate subscale scores, and the total scale score is obtained by summing the scores from all subscales. Higher scores from both the scale and its subscales indicate a higher perceived level of social support. The scale will be applied twice, for the first and last application. The score that can be obtained from the scale varies between 7 and 84.	Between the 11th and 36th weeks of pregnancy,
Primary	The Fatigue Severity Scale	The Fatigue Severity Scale (FSS) was developed by Krupp et al. in 1989. The scale consists of a total of 9 items, and each item is rated on a scale of 1-7 (1=strongly disagree, 7=strongly agree). The total score is obtained by dividing the sum of scores by the number of scale items. The possible total score ranges from 9 to 63, and when divided by the number of items, the lowest possible score is 1, while the highest is 7. A higher score indicates an increased level of fatigue. The scale will be applied twice, for the first and last application.	Between the 11th and 36th weeks of pregnancy,
Primary	Pregnancy Weight Gain	The weight of the pregnant woman will be measured at her first application and at her last application using the scale currently used for pregnant women.	Between the 11th and 36th weeks of pregnancy,
Secondary	Blood pressure arterial (mmHg)	Blood pressure will be measured at the pregnant woman's first application and at her last application using the blood pressure monitor currently used for pregnant women.	Between the 11th and 36th weeks of pregnancy,
Secondary	pulse rate measurements	During the initial visit and the final visit, pulse rate measurements will be manually performed by the attending healthcare personnel.	Between the 11th and 36th weeks of pregnancy,