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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04394273
Other study ID # KA-19121
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 20, 2020
Est. completion date June 1, 2022

Study information

Verified date August 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Pregnancy is a physiological event that lasts for an average of 280 days or 40 weeks, starting with the embryo formed by the combination of ovum and sperm ready for fertilization. Many anatomical, physiological, social and psychological changes occur in the mother's body during pregnancy. In order to better adapt to these changes and to minimize problems during pregnancy, it is very beneficial for pregnants who do not have medical or obstetric risk to increase their physical activity level and exercise. Training programs created in light of the physical activity guidelines prepared specifically for the gestation period during pregnancy should be followed. For this purpose, pregnant programs have been organized routinely as a group exercise two days a week in Hacettepe University, Physical Therapy and Rehabilitation Faculty, Women's & Men's Health Unit since 1990. The scope of this exercise program includes posture and body mechanics training, strengthening the lower and upper extremities, strengthening the abdominal and back muscles, pelvic floor exercises and breathing exercises. In one training session, 20 different exercises are performed and one session lasts about 60 minutes. For pregnant women with time limitations, sessions with less exercise and lasting about 30 minutes are held. Trainings are started in the 16th week of pregnancy and terminated in the 32nd week. Pregnant women who cannot participate in this group exercise program for personal reasons are given recommendations as home programs. In the literature; There is no specific guide on the type of exercise, intensity, and frequency of the exercise that can affect the thickness of the trunk stabilizer muscles during pregnancy, improve functionality and quality of life. With this study, it is planned to investigate the effects of the exercise protocol applied on the thickness, functionality and quality of life of the body stabilizer muscles in pregnant women who routinely participate in the short or long group exercise program, which starts from the 16th week of pregnancy until the 32nd week of the week. In addition, the pregnant women, who could not participate in the short or long group exercise program and started their home program until the 32nd week of pregnancy and made their routine follow-ups, will be evaluated in the 16th and 32nd weeks of pregnancy. At the end of this study; The change between body stabilizer muscle thickness, functionality and quality of life will be examined in three different groups, which continue routine short or long pregnant exercises and who can not participate in group exercise and follow up with the home program. In addition, data on trunk stabilizer muscle thickness, functionality and quality of life obtained from these three different groups will be compared. Thus, the literature will provide evidence of effective exercise protocols on trunk stabilizer muscle thickness, functionality and quality of life.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date June 1, 2022
Est. primary completion date August 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: - Being in the 16th week of pregnancy - Being literate - Not having a history of abdominal surgeryExclusion Criteria: Exclusion Criteri: - Having one of the conditions such as heart disease, restrictive lung disease, cervical insufficiency, continuous bleeding in the second and third trimesters, placenta previa, risk of premature birth, membrane rupture, preeclampsia, and serious anemia. - Not volunteering to participate in the study - Not participating in more than 50% of long or short-term exercise sessions starting from the 16th week of pregnancy to the 32nd week (16 weeks) 2 days a week

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise
stabilization exercise

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary thickness of trunk stabilizer muscles During the ultrasonography evaluation for the fetal development of the pregnant woman who came for routine obstetric examination, the pregnant women were lying in a supine position; Using 5-12 MHz linear probe (Logiq P5, General Electrics, Wisconsin, USA), rectus abdominis (at the level of umbilicus), transversus abdominis, external oblique and internal oblique (from the abdominal lateral) muscles will be bilaterally during axial imaging. Diaphragm thickness measurements will likewise be carried out through the mid-axillary line through the 7th intercostal space. 16-th week to 32-d week of pregnancy
Primary the degree of loss of functionality in low back pain Oswestry Disability Index will be used to evaluate the degree of loss of functionality in low back pain. Its validity and reliability in Turkish was determined in 2004 and consists of 10 items. The items question the severity of pain, self-care, lifting-carrying, walking, sitting, standing, sleep, the degree of pain change, travel and social life. When the total score is calculated, it is multiplied by two and said as a percentage. The maximum score is "100" and the minimum score is "0". As the total score increases, the level of disability increases. 16-th week to 32-d week of pregnancy
Primary The score of quality of life SF-36 will be used to determine the perceived quality of life in physical and mental health areas. SF-36 includes 36 questions and evaluation of eight health areas. These; physical functionality, physical role limitation, physical pain, general health, vitality, social functionality, emotional role restrictions and mental health. Scores from these subscales range from 0-100. "0" indicates poor health, "100" indicates goodness 16-th week to 32-d week of pregnancy
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