NCT04394273

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 27, 2021

Status Verified

August 1, 2021

Enrollment Period

1.4 years

First QC Date

May 14, 2020

Last Update Submit

August 23, 2021

Conditions

Keywords

pregnancy, exercise, stabilization

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (3)

Long- Term Exercise Group

They will exercise one an hour, two days a week, from the 16th week of pregnancy to the 32nd week (16 weeks).In this session, clinical pilates exercises are used as the basic exercise model and this exercise model is applied as a mixed exercise model in the form of posture and body mechanics training, lower-upper extremity strength training, pelvic floor muscle training and breathing exercises. Exercises can be started from the mat level and advanced in a modified manner with theraband and pilates ball.

Other: Exercise

Short-Term Exercise Group

They will exercise half an hour, two days a week, from the 16th week of pregnancy to the 32nd week (16 weeks).n this session, clinical pilates exercises are used as the basic exercise model and this exercise model is applied as a mixed exercise model in the form of posture and body mechanics training, lower-upper extremity strength training, pelvic floor muscle training and breathing exercises. Exercises can be started from the mat level and advanced in a modified manner with theraband and pilates ball.

Other: Exercise

Home Program

Pregnant women who choose the home program group are told to continue their home program until the 32nd week, which includes posture and body mechanics training, increase their physical activity levels and be as active as possible and take daily walks.

Other: Exercise

Interventions

stabilization exercise

Home ProgramLong- Term Exercise GroupShort-Term Exercise Group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women

You may qualify if:

  • Being in the 16th week of pregnancy
  • Being literate

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
16 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 19, 2020

Study Start

February 20, 2020

Primary Completion

August 1, 2021

Study Completion

June 1, 2022

Last Updated

August 27, 2021

Record last verified: 2021-08

Locations