Healthy VolunteersNCT07352722
Intercostal Mobilization and Respiratory Outcomes
A study testing Intercostal mobilization and Rest in people with Healthy Volunteers, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Intercostal mobilization and Rest
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 1 Jun 2026
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between 18 and 30 years old,
- Have a sedentary lifestyle,
- Be willing to participate in the study
Who cannot join
- History of neurological, orthopedic, or cardiopulmonary disease that could affect respiratory function,
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu abant Izzet Baysal University
Bolu, 14030
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Intercostal mobilization, Sham intercostal mobilization, Rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal mobilizationProcedure or surgery
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.
Sham intercostal mobilizationProcedure or surgery
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.
RestOther
Individuals in the control group will be instructed to rest in a supine position for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intercostal Mobilization Group | Experimental | Not described Receives: Procedure: Intercostal mobilization |
| Sham Group | Sham comparator | Not described Receives: Procedure: Sham intercostal mobilization |
| Control Group | Placebo comparator | Not described Receives: Other: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in the first second (FEV1)
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.
Measured: through study completion, an average of 18 months
Forced vital capacity (FVC)
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.
Measured: through study completion, an average of 18 months
FEV1/FVC ratio
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.
Measured: through study completion, an average of 18 months
Mid-expiratory flow rate (FEF25-75)
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.
Measured: through study completion, an average of 18 months
Peak expiratory flow (PEF)
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.
Measured: through study completion, an average of 18 months
Secondary outcomes (2)
Respiratory muscle strength
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
Measured: through study completion, an average of 18 months
Shuttle Walking Test
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."
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start15 Oct 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sezen Tezcan, Abant Izzet Baysal University
- Investigators
- Sezen Tezcan, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352722
- Sponsor's protocol ID
- AIBU-FTR-ST-07
- Status last verified
- Jun 2026
- First submitted
- 3 Dec 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intercostal Mobilization on Respiratory Muscle Strength, Respiratory Function Parameters and Shuttle Walking Test Performance: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07352722
- Acronym / sponsor ID
- AIBU-FTR-ST-07
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 20 Jan 2026 (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.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intercostal Mobilization Group | Experimental | Procedure: Intercostal mobilization |
| Sham Group | Sham comparator | Procedure: Sham intercostal mobilization |
| Control Group | Placebo comparator | Other: Rest |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Be between 18 and 30 years old,
- Have a sedentary lifestyle,
- Be willing to participate in the study
Key exclusion criteria (2 listed)
- History of neurological, orthopedic, or cardiopulmonary disease that could affect respiratory function,
- Refusal to participate in the study
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 |
|---|---|---|
| Intercostal mobilizationParticipants 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. | Procedure or surgery | Intercostal Mobilization Group |
| Sham intercostal mobilizationParticipants 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. | Procedure or surgery | Sham Group |
| RestIndividuals in the control group will be instructed to rest in a supine position for 10 minutes. | Other | Control Group |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Respiratory muscle strength
Time frame: through study completion, an average of 18 months
Shuttle Walking Test
Time frame: through study completion, an average of 18 months
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Sezen Tezcan principal investigator
Abant Izzet Baysal 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 Intercostal mobilization and Rest in people with Healthy Volunteers, run by Abant Izzet Baysal 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 3 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 1 Jul 2026. 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. Some participants in this study may receive a placebo. 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 expiratory volume in the first second (FEV1) (time frame: through study completion, an average of 18 months). The study lists 5 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 1 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.