Core StabilizationNCT06354400
Core Stabilization Training on Chest Expansion, Functional Capacity, Trunk Muscle Endurance in Hearing-Impaired Children
A study testing Core stabilization training in people with Core Stabilization and Respiration, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Core Stabilization, Respiration, Functional Capacity
- What is being tested?
- Core stabilization training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 12 Jun 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of clinically diagnosed prelingual sensorineural hearing loss
- Absence of any neurological or orthopedic problems
- Absence of any mental disorder, developmental disorder or syndrome
- Not having participated in any core (trunk) stabilization exercises during the previous six months
- Not having used any medication that would affect respiratory functions in the last 3 months
Who cannot join
- Intellectual disability that would prevent participation in evaluation and treatment
- Presence of chronic respiratory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Core Stabilization Training on Chest Expansion, Functional Capacity, and Trunk Muscle Endurance in Hearing-Impaired Children
Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions.
Anatomically, core stabilization is provided by the diaphragm, abdominal, hip, pelvic floor, and gluteal muscles. Training for these muscles is intended to improve strength, endurance, and neuromuscular control. This training can help to improve the control of intra-abdominal pressure, intersegmental control of the spine, and muscular control of trunk movement. It also helps in strengthening the respiratory muscles, especially the main inspiratory muscle, the diaphragm. In this study, the effects of core stabilization training on children with hearing impairments' thoracic mobility, functional ability, and trunk muscle endurance will be examined.
Read the detailed description
Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Children with hearing loss can display impaired balance and coordination, as well as decreased muscle strength and respiratory functions. Thoracic mobility relates to the function of respiratory muscles that help expand and contract the ribcage. Exercise capacity, or functional capacity, refers to the individual's ability to perform submaximal activities that require the pulmonary, cardiovascular, and skeletal muscle systems to work together and be healthy. Chest wall expansion determines lung volume and functional capacity. A study in patients with chronic obstructive pulmonary disease showed that lung function was positively associated with reduced chest wall expansion.
Core stabilization is provided anatomically by the abdominal muscles in the front, the spinal and gluteal muscles in the back, the diaphragm above, and the pelvic floor and hip muscles below. Core (trunk) stabilization training is a training to increase strength, endurance, and neuromuscular control of the muscles mentioned above. Thus, intersegmental control of the spine, control of intra-abdominal pressure, and muscular control of trunk movement can be improved. It is also beneficial for strengthening the respiratory muscles, especially the diaphragm, which is the main inspiratory muscle.
When the literature was examined, no studies were found that evaluated the effects of exercise on thoracic mobility (chest expansion) and functional capacity in hearing-impaired children. Our planned study is important because it is the first study to evaluate both chest expansion and functional capacity in hearing-impaired children and also because it is the first study to show the effect of the core stabilization exercise program on chest expansion and functional capacity in these children.
- Conditions
- Core Stabilization, Respiration, Functional Capacity, Endurance, Hearing Impaired Children
- Being tested
- Core stabilization training
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core stabilization trainingOther
Isometric exercises of the abdominal muscles in the supine, prone, and squatting positions; isotonic exercises in the supine, prone, squatting, and side-lying positions; isotonic exercises in coordination with the extremity movements in the supine, prone, and crawling positions; and trunk rotation exercises in the sitting position will be performed. The Swiss ball will be used for dynamic exercises. It will include isometric and isotonic exercises of the abdominal muscles. Exercises will start with 3 sets of 20 repetitions, gradually increase in intensity on static and dynamic surfaces, and progress towards difficulty. Each exercise will be performed in coordination with breathing control. Breathing control will be coordinated with every exercise.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Isometric exercises of the abdominal muscles in the supine, prone, and squatting positions; isotonic exercises in the supine, prone, squatting, and side-lying positions; isotonic exercises in coordination with the extremity movements in the supine, prone, and crawling positions; and trunk rotation exercises in the sitting position will be performed. The Swiss ball will be used for dynamic exercises. It will include isometric and isotonic exercises of the abdominal muscles. Exercises will start with 3 sets of 20 repetitions, gradually increase in intensity on static and dynamic surfaces, and progress towards difficulty. Each exercise will be performed in coordination with breathing control.Breathing control will be coordinated with every exercise. Receives: Other: Core stabilization training |
| Control group | No intervention | Since no training will be given to the control group during the study, we consider it ethically necessary to provide the same training to the control group if it proves effective after the study is over. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chest expansion
Chest wall expansion will be measured with a standard measuring tape at three different levels. While the child is in an upright position, with his feet shoulder-width apart and his arms relaxed at his side, measurements will be taken from three areas: at the axilla level (upper level), at the xiphoid level (middle level) and at the subcostal level (lower level).
The physical therapist standing in front of the child will initially ask the child to breathe normally to determine the tidal volume, after placing the tape measure around the chest. The child will be asked to exhale maximally and then inhale maximally. The difference between the two scales (inhalation - exhalation) will be determined as thoracic expansion (chest expansion). Participants will be instructed to perform three maneuvers and the obtained values will be averaged and recorded. Data will be measured by the same physiotherapist to minimize possible errors due to heterogeneity.
Measured: Baseline and immediately after the training
Secondary outcomes (2)
Functional capacity
The 6-minute walk test (6MWT) is a commonly used submaximal exercise test to assess functional capacity. This test, used to measure cardiovascular endurance, is a clinical indicator of functional capacity and helps measure the ability to perform activities of daily living. The 6MWT will be performed in accordance with The American Thoracic Society guidelines. The participant will be instructed to walk as fast as possible on a 30 m path for 6 minutes, but not to run. The child will sit in a chair close to the starting position and vital values (heart rate and respiratory rate) will be recorded before administering the test. At the end of the test, the distance walked for 6 minutes will be recorded as 6 minutes walking distance (6MWD). After completion of the test, heart rate, respiratory rate will be measured and the child will be asked about the maximum fatigue level after completing the test using the Borg scale.
Measured: Baseline and immediately after the training
Trunk muscle endurance
Curl-up: Measures the muscle endurance of the abdominal muscles. The test begins in a supine position, with the lower extremities abducted at approximately shoulder width and the knees semiflexed. Static back endurance test: Measures the endurance of the back muscles. The test begins in a prone position, with the inguinal area at the end of the table and the pelvis, hips and knees extended flat on the table. Horizontal side bridging: Measures the endurance of the spinal stabilizer muscles. The test begins in a side-lying position with the lower extremities extended and the upper foot placed in front of the lower foot for support.
Measured: Baseline and immediately after the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start30 Mar 2024
- Primary completion12 Jun 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Core StabilizationStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Nuh Naci Yazgan University
- Responsible party
- Principal investigator, Deniz Tuncer, Bezmialem Vakif University
- Investigators
- Deniz Tuncer, PhD, PT, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354400
- Sponsor's protocol ID
- 2022/001-002
- Status last verified
- Jun 2024
- First submitted
- 29 Mar 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core Stabilization Training on Chest Expansion, Functional Capacity, and Trunk Muscle Endurance in Hearing-Impaired Children
- ClinicalTrials.gov ID
- NCT06354400
- Acronym / sponsor ID
- 2022/001-002
- Conditions
- Core Stabilization, Respiration, Functional Capacity, Endurance, Hearing Impaired Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Nuh Naci Yazgan University
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 12 Jun 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 9 Apr 2024 (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.
Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Sensory impairment seen in children with hearing loss can cause balance and coordination disorders, as well as decreased muscle strength and respiratory functions.
Anatomically, core stabilization is provided by the diaphragm, abdominal, hip, pelvic floor, and gluteal muscles. Training for these muscles is intended to improve strength, endurance, and neuromuscular control. This training can help to improve the control of intra-abdominal pressure, intersegmental control of the spine, and muscular control of trunk movement. It also helps in strengthening the respiratory muscles, especially the main inspiratory muscle, the diaphragm. In this study, the effects of core stabilization training on children with hearing impairments' thoracic mobility, functional ability, and trunk muscle endurance will be examined.
Detailed description
Children's motor skills and physical performance increase with age due to the development of neuromuscular and cardiorespiratory systems. Children with hearing loss can display impaired balance and coordination, as well as decreased muscle strength and respiratory functions. Thoracic mobility relates to the function of respiratory muscles that help expand and contract the ribcage. Exercise capacity, or functional capacity, refers to the individual's ability to perform submaximal activities that require the pulmonary, cardiovascular, and skeletal muscle systems to work together and be healthy. Chest wall expansion determines lung volume and functional capacity. A study in patients with chronic obstructive pulmonary disease showed that lung function was positively associated with reduced chest wall expansion.
Core stabilization is provided anatomically by the abdominal muscles in the front, the spinal and gluteal muscles in the back, the diaphragm above, and the pelvic floor and hip muscles below. Core (trunk) stabilization training is a training to increase strength, endurance, and neuromuscular control of the muscles mentioned above. Thus, intersegmental control of the spine, control of intra-abdominal pressure, and muscular control of trunk movement can be improved. It is also beneficial for strengthening the respiratory muscles, especially the diaphragm, which is the main inspiratory muscle.
When the literature was examined, no studies were found that evaluated the effects of exercise on thoracic mobility (chest expansion) and functional capacity in hearing-impaired children. Our planned study is important because it is the first study to evaluate both chest expansion and functional capacity in hearing-impaired children and also because it is the first study to show the effect of the core stabilization exercise program on chest expansion and functional capacity in these children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Core stabilization trainingIsometric exercises of the abdominal muscles in the supine, prone, and squatting positions; isotonic exercises in the supine, prone, squatting, and side-lying positions; isotonic exercises in coordination with the extremity movements in the supine, prone, and crawling positions; and trunk rotation exercises in the sitting position will be performed. The Swiss ball will be used for dynamic exercises. It will include isometric and isotonic exercises of the abdominal muscles. Exercises will start with 3 sets of 20 repetitions, gradually increase in intensity on static and dynamic surfaces, and progress towards difficulty. Each exercise will be performed in coordination with breathing control.Breathing control will be coordinated with every exercise. |
| Control group | No intervention | –Since no training will be given to the control group during the study, we consider it ethically necessary to provide the same training to the control group if it proves effective after the study is over. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Presence of clinically diagnosed prelingual sensorineural hearing loss
- Absence of any neurological or orthopedic problems
- Absence of any mental disorder, developmental disorder or syndrome
- Not having participated in any core (trunk) stabilization exercises during the previous six months
- Not having used any medication that would affect respiratory functions in the last 3 months
Key exclusion criteria (2 listed)
- Intellectual disability that would prevent participation in evaluation and treatment
- Presence of chronic respiratory disease
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 trainingIsometric exercises of the abdominal muscles in the supine, prone, and squatting positions; isotonic exercises in the supine, prone, squatting, and side-lying positions; isotonic exercises in coordination with the extremity movements in the supine, prone, and crawling positions; and trunk rotation exercises in the sitting position will be performed. The Swiss ball will be used for dynamic exercises. It will include isometric and isotonic exercises of the abdominal muscles. Exercises will start with 3 sets of 20 repetitions, gradually increase in intensity on static and dynamic surfaces, and progress towards difficulty. Each exercise will be performed in coordination with breathing control. Breathing control will be coordinated with every exercise. | Other | Study group |
Primary outcome
Chest expansion
Time frame: Baseline and immediately after the training
Chest wall expansion will be measured with a standard measuring tape at three different levels. While the child is in an upright position, with his feet shoulder-width apart and his arms relaxed at his side, measurements will be taken from three areas: at the axilla level (upper level), at the xiphoid level (middle level) and at the subcostal level (lower level). The physical therapist standing in front of the child will initially ask the child to breathe normally to determine the tidal volume, after placing the tape measure around the chest. The child will be asked to exhale maximally and then inhale maximally. The difference between the two scales (inhalation - exhalation) will be determined as thoracic expansion (chest expansion). Participants will be instructed to perform three maneuvers and the obtained values will be averaged and recorded. Data will be measured by the same physiotherapist to minimize possible errors due to heterogeneity.
2 secondary outcomes
Functional capacity
Time frame: Baseline and immediately after the training
Trunk muscle endurance
Time frame: Baseline and immediately after the training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
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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.
Deniz Tuncer, PhD, PT principal investigator
Bezmialem Vakif 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 training in people with Core Stabilization and Respiration, run by Bezmialem Vakif 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 14 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chest expansion (time frame: Baseline and immediately after the training). 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 14 Jun 2024.