HyperkyphosisNCT06853548
Core Stability and Respiratory Parameters in Children With Thoracic Hyperkyphosis
An observational study of Hyperkyphosis and Respiratory Failure, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Hyperkyphosis, defined as an excessive curvature of the thoracic spine beyond normal limits, is among the factors that reduce chest wall mobility and lung function. In modern society, increased sitting durations contribute to increased thoracic kyphosis. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Hyperkyphosis, Respiratory Failure
- What is being tested?
- Assessment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 14 Apr 2025
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: hildren with thoracic hyperkyphosis.
Who may be able to join
- Be between the ages of 7 and 18
- Have a thoracic kyphosis angle (Cobb) of ≥45˚ on a lateral X-ray or a kyphosis index of ≤13
Who cannot join
- Individuals who have undergone major surgery or trauma related to the musculoskeletal system, particularly the spine and upper extremities
- Difficulty in understanding given instructions
- Presence of rigid deformity in the spine (Scheuermann's Kyphosis)
- Presence of congenital deformities (Congenital Kyphosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Core Stability and Respiratory Parameters in Children With Thoracic Hyperkyphosis
Hyperkyphosis, defined as an excessive curvature of the thoracic spine beyond normal limits, is among the factors that reduce chest wall mobility and lung function. In modern society, increased sitting durations contribute to increased thoracic kyphosis. Studies have indicated that an increase in thoracic kyphosis and a decrease in thoracic spinal mobility are associated with reduced respiratory functions, such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
The diaphragm forms the upper part of the core stability system. When contracted, it increases intra-abdominal pressure, contributing to core stability. The diaphragm also contracts in advance of and during limb movements to assist in postural control. Additionally, the diaphragm is the primary respiratory muscle responsible for inspiration. Any functional loss in the diaphragm, which alone accounts for 65-80% of vital capacity, can significantly reduce inspiratory capacity. During forced expiration, muscles such as the rectus abdominis, transversus abdominis, internal obliques, and external obliques play an active role. Specifically, the transversus abdominis, like the diaphragm, increases intra-abdominal pressure and supports trunk stabilization. However, the relationship between respiratory muscle strength and the endurance of core stability muscles remains unclear.
In light of this information, this study aims to investigate the relationship between the endurance of core muscles, which contribute to trunk stabilization, and respiratory parameters in children with thoracic hyperkyphosis.
- Conditions
- Hyperkyphosis, Respiratory Failure
- Being tested
- Assessment
- Keywords
- Thoracic Hyperkyphosis, Respiratory Function, Respiratory Muscle Strength, Core Stability
- Medical subject headings
- Kyphosis, Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentOther
Respiratory function, respiratory muscle strength, and core stability parameters will be assessed in children with hyperkyphosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced vital capacity
Forced vital capacity is the volume of gas expelled from the lungs in a fast, forced and deep expiration after a deep, forced inspiration. Forced vital capacity will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Measured: 2 weeks
Forced expiratory volume in the first second
Forced expiratory volume in the first second is the amount of air expelled from the lungs in the first second with forced expiration. Forced expiratory volume in the first second will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Measured: 2 weeks
Forced vital capacity/Forced expiratory volume Ratio
The Forced vital capacity/Forced expiratory volume Ratio, also called the modified Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. The ratio will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Measured: 2 weeks
Peak expiratory flow rat
Peak expiratory flow rate is the volume of air forcefully expelled from the lungs in one quick exhalation, and is a reliable indicator of ventilation adequacy as well as airflow obstruction. The ratio will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Measured: 2 weeks
Respiratory Muscle Strength
Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with an electronic pressure transducer
Measured: 2 weeks
side bridge test
In the side bridge test, participants will begin in a side-lying position on their dominant side. When ready, they will be instructed to lift their hips without any verbal cues, supporting themselves with one arm. They will be asked to maintain a straight body line and hold this position for as long as possible. Participants will be instructed to place their free hand on their opposite shoulder. The duration for which they can maintain the position will be recorded in seconds.
Measured: 2 weeks
prone bridge test
In the prone bridge test, participants will start in a prone position, supported on their knees and forearms. When they feel ready, they will be instructed to lift their knees off the ground without any verbal cues, maintaining a position supported by their forearms and toes. The duration for which they can hold this position will be recorded in seconds.
Measured: 2 weeks
flexor endurance test
In the flexor endurance test, participants will begin in a supine position. When they feel ready, they will be instructed to pull their knees towards their chest in parallel with the ground without any verbal cues. They will then raise their upper body, lifting the lower edge of their scapula off the ground. The duration for which they can hold this position will be recorded in seconds.
Measured: 2 weeks
Sorenson test
In the Sorenson test, participants will start in a prone position on a stretcher, with their upper body resting on the stretcher. They will be repositioned so that the part of their body in contact with the bed is the anterior superior iliac spine. Participants will be instructed to hold onto the sides of a chair with their hands to maintain balance. A researcher will secure their legs, and when participants feel ready, they will cross both hands over their shoulders without any verbal instructions. They will be asked to hold the position parallel to the ground. The duration for which they can maintain this position will be recorded in seconds.
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Mar 2025
- Primary completion30 Mar 2025
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubra Koce, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853548
- Sponsor's protocol ID
- 24-02
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Core Stability and Respiratory Parameters in Children With Thoracic Hyperkyphosis
- ClinicalTrials.gov ID
- NCT06853548
- Acronym / sponsor ID
- 24-02
- Conditions
- Hyperkyphosis, Respiratory Failure
- Keywords
- Thoracic Hyperkyphosis, Respiratory Function, Respiratory Muscle Strength, Core Stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 3 Mar 2025 (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.
Hyperkyphosis, defined as an excessive curvature of the thoracic spine beyond normal limits, is among the factors that reduce chest wall mobility and lung function. In modern society, increased sitting durations contribute to increased thoracic kyphosis. Studies have indicated that an increase in thoracic kyphosis and a decrease in thoracic spinal mobility are associated with reduced respiratory functions, such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
The diaphragm forms the upper part of the core stability system. When contracted, it increases intra-abdominal pressure, contributing to core stability. The diaphragm also contracts in advance of and during limb movements to assist in postural control. Additionally, the diaphragm is the primary respiratory muscle responsible for inspiration. Any functional loss in the diaphragm, which alone accounts for 65-80% of vital capacity, can significantly reduce inspiratory capacity. During forced expiration, muscles such as the rectus abdominis, transversus abdominis, internal obliques, and external obliques play an active role. Specifically, the transversus abdominis, like the diaphragm, increases intra-abdominal pressure and supports trunk stabilization. However, the relationship between respiratory muscle strength and the endurance of core stability muscles remains unclear.
In light of this information, this study aims to investigate the relationship between the endurance of core muscles, which contribute to trunk stabilization, and respiratory parameters in children with thoracic hyperkyphosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- hildren with thoracic hyperkyphosis.
Key inclusion criteria (2 listed)
- Be between the ages of 7 and 18
- Have a thoracic kyphosis angle (Cobb) of ≥45˚ on a lateral X-ray or a kyphosis index of ≤13
Key exclusion criteria (4 listed)
- Individuals who have undergone major surgery or trauma related to the musculoskeletal system, particularly the spine and upper extremities
- Difficulty in understanding given instructions
- Presence of rigid deformity in the spine (Scheuermann's Kyphosis)
- Presence of congenital deformities (Congenital Kyphosis)
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 |
|---|---|---|
| AssessmentRespiratory function, respiratory muscle strength, and core stability parameters will be assessed in children with hyperkyphosis. | Other | – |
Primary outcome
Forced vital capacity
Time frame: 2 weeks
Forced vital capacity is the volume of gas expelled from the lungs in a fast, forced and deep expiration after a deep, forced inspiration. Forced vital capacity will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Forced expiratory volume in the first second
Time frame: 2 weeks
Forced expiratory volume in the first second is the amount of air expelled from the lungs in the first second with forced expiration. Forced expiratory volume in the first second will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Forced vital capacity/Forced expiratory volume Ratio
Time frame: 2 weeks
The Forced vital capacity/Forced expiratory volume Ratio, also called the modified Tiffeneau-Pinelli index, is a calculated ratio used in the diagnosis of obstructive and restrictive lung disease. The ratio will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Peak expiratory flow rat
Time frame: 2 weeks
Peak expiratory flow rate is the volume of air forcefully expelled from the lungs in one quick exhalation, and is a reliable indicator of ventilation adequacy as well as airflow obstruction. The ratio will be performed in a sitting position using a portable spirometer (Spirobank; MIR, Rome, Italy) according to American Thoracic Society guidelines.
Respiratory Muscle Strength
Time frame: 2 weeks
Respiratory muscle strength will be assessed using maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) with an electronic pressure transducer
side bridge test
Time frame: 2 weeks
In the side bridge test, participants will begin in a side-lying position on their dominant side. When ready, they will be instructed to lift their hips without any verbal cues, supporting themselves with one arm. They will be asked to maintain a straight body line and hold this position for as long as possible. Participants will be instructed to place their free hand on their opposite shoulder. The duration for which they can maintain the position will be recorded in seconds.
prone bridge test
Time frame: 2 weeks
In the prone bridge test, participants will start in a prone position, supported on their knees and forearms. When they feel ready, they will be instructed to lift their knees off the ground without any verbal cues, maintaining a position supported by their forearms and toes. The duration for which they can hold this position will be recorded in seconds.
flexor endurance test
Time frame: 2 weeks
In the flexor endurance test, participants will begin in a supine position. When they feel ready, they will be instructed to pull their knees towards their chest in parallel with the ground without any verbal cues. They will then raise their upper body, lifting the lower edge of their scapula off the ground. The duration for which they can hold this position will be recorded in seconds.
Sorenson test
Time frame: 2weeks
In the Sorenson test, participants will start in a prone position on a stretcher, with their upper body resting on the stretcher. They will be repositioned so that the part of their body in contact with the bed is the anterior superior iliac spine. Participants will be instructed to hold onto the sides of a chair with their hands to maintain balance. A researcher will secure their legs, and when participants feel ready, they will cross both hands over their shoulders without any verbal instructions. They will be asked to hold the position parallel to the ground. The duration for which they can maintain this position will be recorded in seconds.
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 17 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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 Hyperkyphosis and Respiratory Failure, run by Istinye 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 2 inclusion and 4 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 17 Apr 2025. 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?
Forced vital capacity (time frame: 2 weeks). The study lists 9 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 17 Apr 2025.