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临床试验/NCT07352722
NCT07352722已完成不适用

Effect of Intercostal Mobilization on Respiratory Muscle Strength, Respiratory Function Parameters and Shuttle Walking Test Performance: A Randomized Controlled Study

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Forced expiratory volume in the first second (FEV1)

研究概览

简要总结

This cross-sectional study was planned to investigate the effects of intercostal mobilization on respiratory muscle strength, pulmonary function parameters, and performance in the ascending speed shuttle walking test. The study will be conducted in a prospective, randomized, controlled and double-blind design. A total of 90 healthy volunteers aged between 18-30 years with a sedentary lifestyle will be included in the study. The individuals will be divided into 3 groups as Intercostal Mobilization Group (n=30), Sham Application Group (n=30) and Control Group (n=30) by simple randomization. Sociodemographic Data Form, Sedentary Behavior Questionnaire, Pulmonary Function Test, Respiratory Muscle Strength Measurement (MIP/MEP), Incremental Shuttle Walking Test will be applied to the individuals before the intervention. After the intervention, only pulmonary function tests, respiratory muscle strength measurement and ISWT will be repeated. The study results are expected to contribute to the development of new evidence-based approaches to respiratory rehabilitation

详细描述

Breathing is one of the most fundamental biological functions that sustain life. The intake of oxygen and the expulsion of carbon dioxide are essential for sustaining life. Today, respiratory system diseases are among the major health problems worldwide, and according to World Health Organization (WHO) data, they are expected to be the third leading cause of death by 2030. Typical symptoms of these diseases include shortness of breath, coughing, depression/anxiety, fatigue, and pain. The intercostal muscles, which are among the muscles that assist in breathing, are located in the spaces between the ribs and play an important role in the expansion and contraction of the chest cavity. The external intercostal muscles are active during inspiration, while the internal intercostal muscles are active during expiration. The optimal strength and flexibility of these muscles directly affect the efficiency of lung ventilation. Osteopathic manual therapy (OMT) is a treatment approach based on the holistic relationship between body structure and function, aiming to increase structural mobility through various manual techniques. The American Osteopathic Academy describes OMT as a series of techniques focused on the principle that body structure and function are interdependent. Although OMT is not yet included among the standard treatment approaches for respiratory system diseases, it is gaining increasing attention as a complementary method to support thoracic mobility and lung function (intervertebral joints, costovertebral joints, bone structure, all ligaments, muscles, and fascia). The literature reports that applications targeting the intercostal region have positive effects such as an increase in tidal volume, improvement in chest expansion, and a decrease in dyspnea levels. Furthermore, it is stated that increased muscle activity in the intercostal muscles may lead to improvements in respiratory volume and capacity. However, the number of randomized controlled trials designed to attribute these effects solely to intercostal mobilization and conducted on young, healthy individuals is quite limited. This study aims to evaluate the effects of intercostal mobilization applications on respiratory muscle strength, respiratory function parameters, and performance in the increased-rate shuttle run test. Conducted using a randomized controlled design, this research aims to contribute to the development of evidence-based new approaches to respiratory rehabilitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Be between 18 and 30 years old,
  • Have a sedentary lifestyle,
  • Be willing to participate in the study

排除标准

  • History of neurological, orthopedic, or cardiopulmonary disease that could affect respiratory function,
  • Refusal to participate in the study

研究组 & 干预措施

Intercostal Mobilization Group

Experimental

干预措施: Intercostal mobilization (Procedure)

Sham Group

Sham Comparator

干预措施: Sham intercostal mobilization (Procedure)

Control Group

Placebo Comparator

干预措施: Rest (Other)

结局指标

主要结局

Forced expiratory volume in the first second (FEV1)

时间窗: through study completion, an average of 18 months

Forced expiratory volume in the first second (FEV1) will be assessed using a spirometer (MIR Spirobank Oxi) according to ATS and ERS criteria. The test will be repeated at least three times with forced expiration maneuvers in a sitting position, and the best value will be recorded.

Forced vital capacity (FVC)

时间窗: through study completion, an average of 18 months

Forced vital capacity (FVC) will be assessed using a spirometer (MIR Spirobank Oxi) according to ATS and ERS criteria. The test will be repeated at least three times with forced expiration maneuvers in a sitting position, and the best value will be recorded.

FEV1/FVC ratio

时间窗: through study completion, an average of 18 months

FEV1/FVC ratio will be assessed using a spirometer (MIR Spirobank Oxi) according to ATS and ERS criteria. The test will be repeated at least three times with forced expiration maneuvers in a sitting position, and the best value will be recorded.

Mid-expiratory flow rate (FEF25-75)

时间窗: through study completion, an average of 18 months

Mid-expiratory flow rate (FEF25-75) will be assessed using a spirometer (MIR Spirobank Oxi) according to ATS and ERS criteria. The test will be repeated at least three times with forced expiration maneuvers in a sitting position, and the best value will be recorded.

Peak expiratory flow (PEF)

时间窗: through study completion, an average of 18 months

Peak expiratory flow (PEF) will be assessed using a spirometer (MIR Spirobank Oxi) according to ATS and ERS criteria. The test will be repeated at least three times with forced expiration maneuvers in a sitting position, and the best value will be recorded.

次要结局

  • Respiratory muscle strength(through study completion, an average of 18 months)
  • Shuttle Walking Test(through study completion, an average of 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sezen Tezcan

Assist. Prof

Abant Izzet Baysal University

研究点 (1)

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