Intercostal Mobilization and Respiratory Outcomes

June 30, 2026 updated by: Sezen Tezcan, Abant Izzet Baysal University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Bolu, Turkey (Türkiye), 14030
        • Bolu Abant Izzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Control Group
Other: Rest
Individuals in the control group will be instructed to rest in a supine position for 10 minutes.
Sham Comparator: Sham Group
Procedure: Sham intercostal mobilization
Participants lie supine, with the physical therapist performing the mobilization standing beside the bed on the side where the mobilization will be performed. For intercostal mobilization, caudal fixation will not be performed clearly, and instead of fixing the upper edge of the rib, the caudal hand will be positioned on top of the rib. The level of distraction performed by the cranial hand will be reduced so that there is no opening in the intercostal space, and gentle stretches will be applied.
Experimental: Intercostal Mobilization Group
Procedure: Intercostal mobilization
Participants lie supine, with the physical therapist performing the mobilization standing beside the bed on the side to be mobilized. For the upper ribs (ribs 1-5), the ulnar edge of the caudal hand stabilizes the upper edge of the rib below the intercostal space from the anterior side. The cranial hand grasps the participant's elbow, which is in 90° flexion of the shoulder and elbow. For the lower ribs (6th-10th ribs), the caudal hand stabilizes the upper edge of the rib below the intercostal space to be stretched anterolaterally, using the thumb and index finger to grasp the rib. Using the cranial hand, grasp the elbow at the epicondyle level and secure the participant's forearm between your own forearm and thorax. Mobilization is performed by increasing the distance between the fixation hand (caudal hand) and the mobilization hand (cranial hand). The application will be performed bilaterally with 8-10 repetitions for each intercostal space.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced expiratory volume in the first second (FEV1)
Time Frame: 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.
through study completion, an average of 18 months
Forced vital capacity (FVC)
Time Frame: 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.
through study completion, an average of 18 months
FEV1/FVC ratio
Time Frame: 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.
through study completion, an average of 18 months
Mid-expiratory flow rate (FEF25-75)
Time Frame: 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.
through study completion, an average of 18 months
Peak expiratory flow (PEF)
Time Frame: 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.
through study completion, an average of 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Respiratory muscle strength
Time Frame: through study completion, an average of 18 months
Respiratory muscle strength will be assessed with a portable electronic mouth pressure device (MEC Pocket-Spiro® MPM 100) in accordance with European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines (ATS, 2002). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) will be measured using Müller and Valsalva maneuvers. For MIP, participants will exhale maximally to residual volume, then inhale rapidly to total lung capacity; for MEP, they will inhale maximally to total lung capacity and then exhale forcefully. Assessments will be performed in an upright sitting position with a nose clip, and participants will be verbally encouraged. The highest value will be recorded, provided the difference between two trials does not exceed 5% or 5 cmH₂O. Percent predicted values adjusted for age and sex will also be used
through study completion, an average of 18 months
Shuttle Walking Test
Time Frame: through study completion, an average of 18 months
The shuttle run test is a maximal exercise test used to evaluate aerobic capacity and functional exercise tolerance. It is performed with two cones placed 9 meters apart, creating a 10-meter course including turns. Participants walk or run back and forth in time with audio cues, starting at a low speed that increases every minute. The test ends if the participant fails to reach the cone within 0.5 meters on two consecutive cues or develops limiting symptoms (e.g., chest pain, confusion, dizziness, severe fatigue, intolerable dyspnea, SpO₂ <80%). The test consists of 12 levels and is completed when the individual reaches the maximum level or cannot continue."
through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abant Izzet Baysal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sezen Tezcan, Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AIBU-FTR-ST-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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