Core StabilizationNCT05970523
The Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture on Sedentary Individuals
A study testing Core Stabilization Exercises in people with Core Stabilization and Sedentary Behavior, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
There are very few studies on the effect of core stabilization exercises on balance, posture and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the study is to investigate the effects of core stabilization exercises on balance, trunk muscle endurance and posture in healthy sedentary… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Core Stabilization, Sedentary Behavior
- What is being tested?
- Core Stabilization Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Apr 2023to May 2024
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be voluntary to participate in the study
- Being between the ages of 18-40
- Being sedentary
Who cannot join
- Not volunteering to participate in the study
- Having a complaint of low back pain in the last two months
- Being pregnant
- Having chronic lower extremity pain
- Having an orthopedic disease and undergoing a surgical operation
- Having had abdominal surgery
- Being a neurological disease pathology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture in Healthy Sedentary Individuals
There are very few studies on the effect of core stabilization exercises on balance, posture and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the study is to investigate the effects of core stabilization exercises on balance, trunk muscle endurance and posture in healthy sedentary individuals. According to the results of International Physical Activity Questionnaire, the researcher includes sedentary individuals over the age of 18 in the study. The participants are divided into two groups as control (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle endurance tests. Intervention includes core stabilization exercises 3 times a week and walking twice a week for 6 weeks. There is no treatment or intervention for the control group. The researcher evaluates both groups at the beginning and 6 weeks after the intervention.
Read the detailed description
Core stabilization exercises are performed under the supervision of a physiotherapist as face-to-face exercises, guided online exercises, and as an individual home exercise each once a week, totaling 3 times a week. Each exercise will be performed with 10 repetitions for 8 seconds. Each of the exercises is varied from easy to difficult. Progress in the exercises will be achieved by increasing the difficulty level of the exercises according to the condition of the participant once every two weeks.
- Conditions
- Core Stabilization, Sedentary Behavior
- Being tested
- Core Stabilization Exercises
- Keywords
- Trunk Muscle Endurance, Balance, Posture
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization ExercisesOther
Core stabilization exercises are known as a very effective exercise method based on the motor learning principle, performed with the individual's own body weight to strengthen the muscles, improve balance, posture, trunk muscle endurance and flexibility.Each exercise was performed for 7-8 seconds with 10 repetitions. Progression in the exercises was achieved by increasing the difficulty level of the exercises according to the participant's condition once every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | Intervention includes core stabilization exercises for 45 minutes 3 times a week. Participants do exercise face to face under supervision of a physiotherapist and via an online application under the supervision of a physiotherapist once a week. Also participants do home exercise once a week. Exercise group walk for an hour in other two days. Receives: Other: Core Stabilization Exercises |
| Control Group | No intervention | There is no exercise or intervention for control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New York Posture Assessment Scale
This test assesses alignment of various body parts of an individual in anatomical position. The New York Posture Rating Scale detects postural changes. There are 3 figure drawings for each of the 13 different body parts that provide general postural alignment. In the evaluation, five (5) points are given if the person's posture is correct, three (3) points if moderately impaired, and one (1) point if severely impaired. At the end of the evaluation, the total maximum score is 65 and the minimum is 13. Postural disturbances increase as the score decreases.
Measured: 6 weeks
KoreBalance Balance System
The Korebalance Balance System is a computerized balance and exercise system. The software of the system assigns a score following static and dynamic balance evaluations. As stated in the device manual, a score of 700 and below was considered normal and above was considered risky for static balance and a score of 2000 and below was considered normal and above was considered risky for dynamic tests. A higher score is associated with more balance disorders.
Measured: 6 weeks
Trunk Muscle Endurance Tests
The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated by recording the maximum time that the person can maintain the test position. Measurements are made using a stopwatch and the result is recorded in seconds. The tests are repeated twice to save the best measurement value. Tests are terminated when the participant's position deteriorates or when the participant says cannot continue the test.
Measured: 6 weeks
International Physical Activity Questionnaire
This survey lists activities and requests estimates of duration and frequency for each activity performed in the past week. The times are multiplied by the known Metabolic Equivalents (METs) per activity and the results for all items are summed, resulting in the overall physical activity score.
Measured: Before Intervention (First Assesment)
Secondary outcomes (1)
The Stabilizer Pressure Biofeedback Unite
This device evaluates contraction of deep abdominal muscles, muscle activity and segmental stability. The device has values between 0 mmHg and 200 mmHg, varying in intervals of 2 mmHg. Movement or change in position causes volume changes in the pressure bag.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start27 Apr 2023
- Primary completion30 Nov 2023
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Core StabilizationStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- I applied exercise intervention for the intervention group. I will not apply any intervention for the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Nur Yumak, Medipol University
- Investigators
- Ayşe Nur Tunali, Professor, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970523
- Sponsor's protocol ID
- E-10840098-772.02-2555
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70.
PubMed 20940644Hung KC, Chung HW, Yu CC, Lai HC, Sun FH. Effects of 8-week core training on core endurance and running economy. PLoS One. 2019 Mar 8;14(3):e0213158. doi: 10.1371/journal.pone.0213158. eCollection 2019.
PubMed 30849105von Garnier K, Koveker K, Rackwitz B, Kober U, Wilke S, Ewert T, Stucki G. Reliability of a test measuring transversus abdominis muscle recruitment with a pressure biofeedback unit. Physiotherapy. 2009 Mar;95(1):8-14. doi: 10.1016/j.physio.2008.10.003. Epub 2009 Jan 22.
PubMed 19627680Dogruoz Karatekin B, Yasin S, Yumusakhuylu Y, Bayram F, Icagasioglu A. Validity of the Korebalance(R) Balance System in Patients with Postmenopausal Osteoporosis. Medeni Med J. 2020;35(2):79-84. doi: 10.5222/MMJ.2020.18828. Epub 2020 Jun 30.
PubMed 32733755Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
PubMed 17141568Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
PubMed 21058606
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Core Stabilization Exercises on Balance, Trunk Muscle Endurance and Posture in Healthy Sedentary Individuals
- ClinicalTrials.gov ID
- NCT05970523
- Acronym / sponsor ID
- E-10840098-772.02-2555
- Conditions
- Core Stabilization, Sedentary Behavior
- Keywords
- Trunk Muscle Endurance, Balance, Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- May 2024 (estimated)
- First posted
- 1 Aug 2023 (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.
There are very few studies on the effect of core stabilization exercises on balance, posture and trunk muscle endurance in healthy sedentary individuals in literature. The goal of the study is to investigate the effects of core stabilization exercises on balance, trunk muscle endurance and posture in healthy sedentary individuals. According to the results of International Physical Activity Questionnaire, the researcher includes sedentary individuals over the age of 18 in the study. The participants are divided into two groups as control (n=21) and exercise (n=21) groups. The outcome measures are The Stabilizer Pressure Biofeedback Unit, New York Posture Assesment Scale, Korebalance Balance System, trunk muscle endurance tests. Intervention includes core stabilization exercises 3 times a week and walking twice a week for 6 weeks. There is no treatment or intervention for the control group. The researcher evaluates both groups at the beginning and 6 weeks after the intervention.
Detailed description
Core stabilization exercises are performed under the supervision of a physiotherapist as face-to-face exercises, guided online exercises, and as an individual home exercise each once a week, totaling 3 times a week. Each exercise will be performed with 10 repetitions for 8 seconds. Each of the exercises is varied from easy to difficult. Progress in the exercises will be achieved by increasing the difficulty level of the exercises according to the condition of the participant once every two weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- I applied exercise intervention for the intervention group. I will not apply any intervention for the control group.
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Core Stabilization ExercisesIntervention includes core stabilization exercises for 45 minutes 3 times a week. Participants do exercise face to face under supervision of a physiotherapist and via an online application under the supervision of a physiotherapist once a week. Also participants do home exercise once a week. Exercise group walk for an hour in other two days. |
| Control Group | No intervention | –There is no exercise or intervention for control group. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be voluntary to participate in the study
- Being between the ages of 18-40
- Being sedentary
Key exclusion criteria (7 listed)
- Not volunteering to participate in the study
- Having a complaint of low back pain in the last two months
- Being pregnant
- Having chronic lower extremity pain
- Having an orthopedic disease and undergoing a surgical operation
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 |
|---|---|---|
| Core Stabilization ExercisesCore stabilization exercises are known as a very effective exercise method based on the motor learning principle, performed with the individual's own body weight to strengthen the muscles, improve balance, posture, trunk muscle endurance and flexibility.Each exercise was performed for 7-8 seconds with 10 repetitions. Progression in the exercises was achieved by increasing the difficulty level of the exercises according to the participant's condition once every two weeks. | Other | Exercise Group |
Primary outcome
New York Posture Assessment Scale
Time frame: 6 weeks
This test assesses alignment of various body parts of an individual in anatomical position. The New York Posture Rating Scale detects postural changes. There are 3 figure drawings for each of the 13 different body parts that provide general postural alignment. In the evaluation, five (5) points are given if the person's posture is correct, three (3) points if moderately impaired, and one (1) point if severely impaired. At the end of the evaluation, the total maximum score is 65 and the minimum is 13. Postural disturbances increase as the score decreases.
KoreBalance Balance System
Time frame: 6 weeks
The Korebalance Balance System is a computerized balance and exercise system. The software of the system assigns a score following static and dynamic balance evaluations. As stated in the device manual, a score of 700 and below was considered normal and above was considered risky for static balance and a score of 2000 and below was considered normal and above was considered risky for dynamic tests. A higher score is associated with more balance disorders.
Trunk Muscle Endurance Tests
Time frame: 6 weeks
The endurance of the trunk flexor, trunk extensor and lateral flexor muscles is evaluated by recording the maximum time that the person can maintain the test position. Measurements are made using a stopwatch and the result is recorded in seconds. The tests are repeated twice to save the best measurement value. Tests are terminated when the participant's position deteriorates or when the participant says cannot continue the test.
International Physical Activity Questionnaire
Time frame: Before Intervention (First Assesment)
This survey lists activities and requests estimates of duration and frequency for each activity performed in the past week. The times are multiplied by the known Metabolic Equivalents (METs) per activity and the results for all items are summed, resulting in the overall physical activity score.
1 secondary outcome
The Stabilizer Pressure Biofeedback Unite
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Results publication: PubMed 20940644Sekendiz B, Cug M, Korkusuz F. Effects of Swiss-ball core strength training on strength, endurance, flexibility, and balance in sedentary women. J Strength Cond Res. 2010 Nov;24(11):3032-40. doi: 10.1519/JSC.0b013e3181d82e70.
- Results publication: PubMed 30849105Hung KC, Chung HW, Yu CC, Lai HC, Sun FH. Effects of 8-week core training on core endurance and running economy. PLoS One. 2019 Mar 8;14(3):e0213158. doi: 10.1371/journal.pone.0213158. eCollection 2019.
- Results publication: PubMed 19627680von Garnier K, Koveker K, Rackwitz B, Kober U, Wilke S, Ewert T, Stucki G. Reliability of a test measuring transversus abdominis muscle recruitment with a pressure biofeedback unit. Physiotherapy. 2009 Mar;95(1):8-14. doi: 10.1016/j.physio.2008.10.003. Epub 2009 Jan 22.
- Results publication: PubMed 32733755Dogruoz Karatekin B, Yasin S, Yumusakhuylu Y, Bayram F, Icagasioglu A. Validity of the Korebalance(R) Balance System in Patients with Postmenopausal Osteoporosis. Medeni Med J. 2020;35(2):79-84. doi: 10.5222/MMJ.2020.18828. Epub 2020 Jun 30.
- Results publication: PubMed 17141568Evans K, Refshauge KM, Adams R. Trunk muscle endurance tests: reliability, and gender differences in athletes. J Sci Med Sport. 2007 Dec;10(6):447-55. doi: 10.1016/j.jsams.2006.09.003. Epub 2006 Dec 1.
- Results publication: PubMed 21058606Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.
- Individual participant dataSharing planned: No
Related trials for Core Stabilization
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
PNF Effects on Volleyball Performance
Sport Injuries
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.
Ayşe Nur Tunali, Professor study director
Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercises in people with Core Stabilization and Sedentary Behavior, run by Medipol 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 7 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 28 Feb 2024. 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?
New York Posture Assessment Scale (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05970523, which also lists 6 linked publications.
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 28 Feb 2024.