Intercostal Mobilization and Respiratory Outcomes

NCT07352722 | Recruiting

• 1 other identifier: AIBU-FTR-ST-07
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  through study completion, an average of 18 months

Secondary Outcomes (2)

• Respiratory muscle strength

  through study completion, an average of 18 months

• Shuttle Walking Test

  through study completion, an average of 18 months

Study Arms (3)

Intercostal Mobilization Group

EXPERIMENTAL

Procedure: Intercostal mobilization

Sham Group

SHAM COMPARATOR

Procedure: Sham intercostal mobilization

Control Group

PLACEBO COMPARATOR

Other: Rest

Interventions

Intercostal mobilization PROCEDURE

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.

Intercostal Mobilization Group

Sham intercostal mobilization PROCEDURE

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.

Sham Group

Rest OTHER

Individuals in the control group will be instructed to rest in a supine position for 10 minutes.

Control Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu abant Izzet Baysal University

Bolu, 14030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Officials

• Sezen Tezcan

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sezen Tezcan

CONTACT

+905445723731; fztsezen@windowslive.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 20, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)