Restrictive Lung DiseaseNCT07012733
Thoracic Mobilization for Restrictive Lung Disease
A study testing Thoracic mobilization and conventional therapy in people with Restrictive Lung Disease, run by Chungnam National University Sejong Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Restrictive Lung Disease
- What is being tested?
- Thoracic mobilization and conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2025to 26 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- FEV1/FVC ratio < 70%
- Evidence of airway obstruction on pulmonary function testing
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Chungnam National University Sejong Hospital
Sejong, 30099
Jungwoo Shim, PT, PhD Candidate, +82 10-2509-6107, sjw0812@naver.com
About this study
Official title: A Randomized Controlled Trial Comparing the Effects of Thoracic Mobilization and Conventional Respiratory Therapy on Cough Capacity, Dyspnea, and Pulmonary Function in Patients With Restrictive Lung Disease
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.
Read the detailed description
Restrictive lung disease (RLD) is characterized by reduced lung compliance and limited thoracic mobility, leading to decreased lung volume and impaired respiratory function. Manual therapy interventions such as thoracic mobilization have been proposed to improve chest wall flexibility and enhance respiratory efficiency. However, few studies have examined the immediate clinical effects of such interventions in RLD patients.
This single-group pre-post interventional study will evaluate the short-term outcomes of thoracic mobilization techniques on cough capacity (as measured by peak cough flow), dyspnea (via Borg scale), and pulmonary function (forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1]). The results are expected to provide preliminary evidence on the effectiveness of thoracic mobilization for improving respiratory performance in individuals with RLD.
- Conditions
- Restrictive Lung Disease
- Being tested
- Thoracic mobilization, conventional therapy
- Keywords
- thoracic mobilization, pulmonary function, cough capacity, dyspnea, restrictive pulmonary disorder
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic mobilizationOther
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.
conventional therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic mobilization group | Experimental | Participants receive thoracic mobilization techniques Receives: Other: Thoracic mobilization; Other: conventional therapy |
| conventional therapy group | Active comparator | Participants receive conventional respiratory therapy Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and immediately after intervention on Day 1
Secondary outcomes (2)
Cough peak flow
Cough peak flow will be measured using a peak flow meter. Participants will be instructed to perform a maximal voluntary cough following a deep inspiration, and the highest value from three trials will be recorded. The assessment will be conducted by a trained therapist to evaluate cough capacity.
Measured: Immediately before and immediately after intervention on Day 1
Dyspnea
Dyspnea will be assessed using the modified Borg scale, a subjective rating scale ranging from 0 (no breathlessness) to 10 (maximum breathlessness). Participants will rate their perceived level of dyspnea at rest following the intervention. The assessment will be administered by a trained therapist.
Measured: Immediately before and immediately after intervention on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start9 Jun 2025 (estimated)
- Primary completion18 Nov 2025 (estimated)
- Study completion26 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restrictive Lung DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel-group clinical trial comparing thoracic mobilization techniques to conventional respiratory therapy in patients with restrictive lung disease.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungnam National University Sejong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012733
- Sponsor's protocol ID
- CNUSH2025-04-001
- Other IDs
- CNUSH2025-04-001
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing the Effects of Thoracic Mobilization and Conventional Respiratory Therapy on Cough Capacity, Dyspnea, and Pulmonary Function in Patients With Restrictive Lung Disease
- ClinicalTrials.gov ID
- NCT07012733
- Acronym / sponsor ID
- CNUSH2025-04-001
- Conditions
- Restrictive Lung Disease
- Keywords
- thoracic mobilization, pulmonary function, cough capacity, dyspnea, restrictive pulmonary disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chungnam National University Sejong HospitalUniversity, hospital or other
- Study start
- 9 Jun 2025 (estimated)
- Primary completion
- 18 Nov 2025 (estimated)
- Study completion
- 26 Dec 2025 (estimated)
- First posted
- 10 Jun 2025 (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 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.
Detailed description
Restrictive lung disease (RLD) is characterized by reduced lung compliance and limited thoracic mobility, leading to decreased lung volume and impaired respiratory function. Manual therapy interventions such as thoracic mobilization have been proposed to improve chest wall flexibility and enhance respiratory efficiency. However, few studies have examined the immediate clinical effects of such interventions in RLD patients.
This single-group pre-post interventional study will evaluate the short-term outcomes of thoracic mobilization techniques on cough capacity (as measured by peak cough flow), dyspnea (via Borg scale), and pulmonary function (forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1]). The results are expected to provide preliminary evidence on the effectiveness of thoracic mobilization for improving respiratory performance in individuals with RLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, parallel-group clinical trial comparing thoracic mobilization techniques to conventional respiratory therapy in patients with restrictive lung disease.
| Arm | Type | Receives |
|---|---|---|
| Thoracic mobilization group | Experimental | Other: Thoracic mobilization, Other: conventional therapyParticipants receive thoracic mobilization techniques |
| conventional therapy group | Active comparator | Other: conventional therapyParticipants receive conventional respiratory therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- FEV1/FVC ratio < 70%
- Evidence of airway obstruction on pulmonary function testing
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 |
|---|---|---|
| Thoracic mobilizationParticipants 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. | Other | Thoracic mobilization group |
| conventional therapyParticipants 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. | Other | Thoracic mobilization group, conventional therapy group |
Primary outcome
Pulmonary function test
Time frame: Immediately before and immediately after intervention on Day 1
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.
2 secondary outcomes
Cough peak flow
Time frame: Immediately before and immediately after intervention on Day 1
Dyspnea
Time frame: Immediately before and immediately after intervention on Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Results publicationKelzuyuki, 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.
- Individual participant dataSharing planned: Yes. 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic mobilization and conventional therapy in people with Restrictive Lung Disease, run by Chungnam National University Sejong Hospital at 1 site in South Korea.
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 5 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: opening soon, as of the sponsor's last update on 10 Jun 2025. 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 South Korea. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jungwoo Shim, PT, PhD Candidate (+82 10-2509-6107, sjw0812@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function test (time frame: Immediately before and immediately after intervention on Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07012733, which also lists 1 linked publication.
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 10 Jun 2025.