NCT07012733

Brief Summary

This study aims to investigate the immediate effects of thoracic mobilization techniques on cough capacity, dyspnea, and pulmonary function in patients with restrictive lung disease. The intervention will be applied in a single session, and outcomes will be measured before and after the intervention to evaluate short-term physiological changes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

May 22, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

June 9, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2025

Completed
Last Updated

June 10, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

May 22, 2025

Last Update Submit

June 1, 2025

Conditions

Keywords

thoracic mobilizationpulmonary functioncough capacitydyspnearestrictive pulmonary disorder

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function test

    Pulmonary function will be assessed using a standard spirometry test, including FVC and FEV1. The test will be conducted by a trained technician according to ATS/ERS guidelines to evaluate respiratory function.

    Immediately before and immediately after intervention on Day 1

Secondary Outcomes (2)

  • Cough peak flow

    Immediately before and immediately after intervention on Day 1

  • Dyspnea

    Immediately before and immediately after intervention on Day 1

Study Arms (2)

Thoracic mobilization group

EXPERIMENTAL

Participants receive thoracic mobilization techniques

Other: Thoracic mobilizationOther: conventional therapy

conventional therapy group

ACTIVE COMPARATOR

Participants receive conventional respiratory therapy

Other: conventional therapy

Interventions

Participants in this group will receive thoracic mobilization techniques in addition to conventional respiratory therapy. Thoracic mobilization will be delivered by a licensed physical therapist using passive manual techniques targeting the thoracic spine and rib cage to improve chest wall mobility and respiratory function.

Thoracic mobilization group

Participants in this group will receive conventional respiratory therapy, including diaphragmatic breathing, pursed-lip breathing, and chest expansion exercises. The therapy will be administered by a licensed physical therapist following standard pulmonary rehabilitation protocols.

Thoracic mobilization groupconventional therapy group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19 years or older
  • Currently receiving respiratory therapy at C Hospital in Sejong City
  • Pulmonary function test indicating restrictive pattern: FVC \< 80% and FEV1/FVC ≥ 70%
  • FVC above the lower limit of normal (LLN) for age and sex
  • Diagnosed with restrictive lung disease, such as idiopathic pulmonary fibrosis, scoliosis, or neuromuscular disorders (e.g., myopathy, amyotrophic lateral sclerosis)

You may not qualify if:

  • FEV1/FVC ratio \< 70%
  • Evidence of airway obstruction on pulmonary function testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Sejong Hospital

Sejong, 30099, South Korea

Location

Related Publications (1)

  • Kelzuyuki, T., Noriko, S. The immediate effect of chest mobilization tech. in patients of COPD. The Journal of Japanese Physical Therapy Association.(JPTA). 2007;34(2): 20070420.

    BACKGROUND

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Jungwoo Shim, PT, PhD Candidate

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blinded to group assignment to minimize detection bias during post-intervention evaluations
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized, parallel-group clinical trial comparing thoracic mobilization techniques to conventional respiratory therapy in patients with restrictive lung disease.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 10, 2025

Study Start

June 9, 2025

Primary Completion

November 18, 2025

Study Completion

December 26, 2025

Last Updated

June 10, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared upon reasonable request for academic purposes. Data will be available from 6 months after publication of the primary results for a period of 2 years.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD and supporting documents will be available beginning 6 months after publication of the primary results and will be accessible for up to 2 years.
Access Criteria
De-identified individual participant data and supporting documents will be available to qualified researchers for academic purposes. Requests must include a methodologically sound proposal and will be subject to approval by the study team. Data will be shared through secure institutional data transfer.

Locations