NCT06853548

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

29 days

First QC Date

February 25, 2025

Last Update Submit

April 14, 2025

Conditions

Keywords

Thoracic HyperkyphosisRespiratory FunctionRespiratory Muscle StrengthCore Stability

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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.

    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

    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.

    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.

    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.

    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.

    2weeks

Interventions

Respiratory function, respiratory muscle strength, and core stability parameters will be assessed in children with hyperkyphosis.

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

hildren with thoracic hyperkyphosis.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KyphosisRespiratory InsufficiencyRespiratory Aspiration

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

March 1, 2025

Primary Completion

March 30, 2025

Study Completion

April 14, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations