PregnancyNCT04394273
The Effects of Exercise Training During Pregnancy
An observational study of Pregnancy, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Exercise
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2020to 1 Jun 2022
- How long will I take part?
- 16 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women
Who may be able to join
- Being in the 16th week of pregnancy
- Being literate
- Not having a history of abdominal surgeryExclusion Criteria:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise Training on Trunk Stabilizer Muscle Thickness, Functionality and Quality of Life During Pregnancy
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.
Read more
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.
- Conditions
- Pregnancy
- Being tested
- Exercise
- Keywords
- pregnancy, exercise, stabilization
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
stabilization exercise
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 16-th week to 32-d week of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start20 Feb 2020
- Primary completion1 Aug 2021
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
- Target duration
- 16 Weeks
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turkan Akbayrak, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394273
- Sponsor's protocol ID
- KA-19121
- Status last verified
- Aug 2021
- First submitted
- 14 May 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise Training on Trunk Stabilizer Muscle Thickness, Functionality and Quality of Life During Pregnancy
- ClinicalTrials.gov ID
- NCT04394273
- Acronym / sponsor ID
- KA-19121
- Conditions
- Pregnancy
- Keywords
- pregnancy, exercise, stabilization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 16 Weeks
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long- Term Exercise Group | – | Other: ExerciseThey 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. |
| Short-Term Exercise Group | – | Other: ExerciseThey 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. |
| Home Program | – | Other: ExercisePregnant 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women
Key inclusion criteria (3 listed)
- Being in the 16th week of pregnancy
- Being literate
- Not having a history of abdominal surgeryExclusion Criteria:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisestabilization exercise | Other | Home Program, Long- Term Exercise Group, Short-Term Exercise Group |
Primary outcome
thickness of trunk stabilizer muscles
Time frame: 16-th week to 32-d week of pregnancy
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.
the degree of loss of functionality in low back pain
Time frame: 16-th week to 32-d week of pregnancy
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.
The score of quality of life
Time frame: 16-th week to 32-d week of pregnancy
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thickness of trunk stabilizer muscles (time frame: 16-th week to 32-d week of pregnancy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2021.