Chronic Obstructive Pulmonary Disease (COPD)NCT07539974
Effect of Inspiratory Muscle Training on Diaphragm Function in COPD Patients
A study testing Threshold Inspiratory Muscle Training and Philips Respironics Threshold IMT device in people with Chronic Obstructive Pulmonary Disease (COPD) and Diaphragm Dysfunction, run by Universitas Padjadjaran.
Trial summary
This study investigates the effect of threshold inspiratory muscle training on diaphragm thickness and diaphragm excursion, measured using ultrasonography, in patients with stable chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 59 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Diaphragm Dysfunction
- What is being tested?
- Threshold Inspiratory Muscle Training and Philips Respironics Threshold IMT device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Sep 2026
- 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 40 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a COPD GOLD stage 2
- Age 40-59 years
- Maximal Inspiratory Pressure (MIP) value of less than 70 cmH₂O or below the lower limit of normal for their age and gender
- Clinically stable for at least 4 weeks prior to the study
- Ready to participate in research and sign informed consent
Who cannot join
- Patients with contraindications to Inspiratory Muscle Training or spirometry (e.g., recent thoracic or abdominal surgery, pneumothorax, or history of spontaneous pneumothorax).
- Patients participating in other structured respiratory muscle training or pulmonary rehabilitation programs concurrently that could confound the results
- Patients undergoing other therapies that may affect diaphragmatic muscle measurement results, such as electrical diaphragmatic stimulation
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Threshold Inspiratory Muscle Training on Diaphragm Thickness and Diaphragm Excursion Value in Chronic Obstructive Pulmonary Disease Patients
This study investigates the effect of threshold inspiratory muscle training on diaphragm thickness and diaphragm excursion, measured using ultrasonography, in patients with stable chronic obstructive pulmonary disease (COPD).
Read the detailed description
This quasi-experimental study with a pretest-posttest design evaluates the effect of a 6-week structured threshold inspiratory muscle training program on diaphragm thickness and diaphragm excursion in patients with stable COPD. Conducted at the medical rehabilitation polyclinic of Rotinsulu Hospital, Bandung, this study includes patients who meet specific inclusion criteria. The intervention is performed once daily, five times per week, with progressive intensity based on maximal inspiratory pressure using a threshold device. Outcomes will be assessed using ultrasonography to measure diaphragm thickness and diaphragm excursion before and after the intervention.
- Being tested
- Threshold Inspiratory Muscle Training, Philips Respironics Threshold IMT device
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold Inspiratory Muscle TrainingOther
Also called Inspiratory Muscle Training (IMT), Threshold IMT
Threshold inspiratory muscle training performed using a threshold loading device to improve inspiratory muscle strength. Training is conducted once daily, five times per week for 6 weeks, with intensity starting at 30% and progressively increasing up to 50% of maximal inspiratory pressure (MIP) based on patient tolerance.
Philips Respironics Threshold IMT deviceDevice
A threshold loading device used to provide inspiratory resistance during inspiratory muscle training
| Study group | Role | What they receive |
|---|---|---|
| Threshold Inspiratory Muscle Training | Experimental | Not described Receives: Other: Threshold Inspiratory Muscle Training; Device: Philips Respironics Threshold IMT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickness (cm)
Diaphragm thickness reflects the structural characteristics of the diaphragm muscle and is measured at end-inspiration and end-expiration using ultrasonography. The values are expressed in centimeters (cm).
Measured: Baseline to Week 6
Diaphragm Excursion (cm)
Diaphragm excursion represents the vertical movement of the diaphragm during the respiratory cycle, reflecting diaphragmatic mobility and function. Measurements are obtained using ultrasonography and expressed in centimeters (cm).
Measured: Baseline to Week 6
Secondary outcomes (3)
Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) is assessed using spirometry and measured in liters (L). It represents the total volume of air that can be forcibly exhaled after a full inhalation and reflects overall lung capacity.
Measured: Baseline to Week 6
Forced Expiratory Volume in one second (FEV1)
Forced Expiratory Volume in one second (FEV1) is measured using spirometry and expressed in liters (L). It represents the volume of air exhaled in the first second of a forced expiration.
Measured: Baseline to Week 6
Peak Expiratory Flow (PEF)
Peak Expiratory Flow (PEF) is measured using spirometry and expressed in liters per second (L/s). It reflects the maximum airflow achieved during forced expiration and indicates airway function.
Measured: Baseline to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group assignment with pretest-posttest assessment. All participants receive threshold inspiratory muscle training, and outcomes are measured before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- Hasan Sadikin General Hospital
- Responsible party
- Sponsor
- Investigators
- Dian M. Sari, MD., M.Sc., Ph.D, Principal investigator, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539974
- Sponsor's protocol ID
- IKFR-202604.01
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- 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 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Threshold Inspiratory Muscle Training on Diaphragm Thickness and Diaphragm Excursion Value in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT07539974
- Acronym / sponsor ID
- IKFR-202604.01
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- Hasan Sadikin General Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 20 Apr 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 study investigates the effect of threshold inspiratory muscle training on diaphragm thickness and diaphragm excursion, measured using ultrasonography, in patients with stable chronic obstructive pulmonary disease (COPD).
Detailed description
This quasi-experimental study with a pretest-posttest design evaluates the effect of a 6-week structured threshold inspiratory muscle training program on diaphragm thickness and diaphragm excursion in patients with stable COPD. Conducted at the medical rehabilitation polyclinic of Rotinsulu Hospital, Bandung, this study includes patients who meet specific inclusion criteria. The intervention is performed once daily, five times per week, with progressive intensity based on maximal inspiratory pressure using a threshold device. Outcomes will be assessed using ultrasonography to measure diaphragm thickness and diaphragm excursion before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group assignment with pretest-posttest assessment. All participants receive threshold inspiratory muscle training, and outcomes are measured before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Threshold Inspiratory Muscle Training | Experimental | Other: Threshold Inspiratory Muscle Training, Device: Philips Respironics Threshold IMT device |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with a COPD GOLD stage 2
- Age 40-59 years
- Maximal Inspiratory Pressure (MIP) value of less than 70 cmH₂O or below the lower limit of normal for their age and gender
- Clinically stable for at least 4 weeks prior to the study
- Ready to participate in research and sign informed consent
Key exclusion criteria (3 listed)
- Patients with contraindications to Inspiratory Muscle Training or spirometry (e.g., recent thoracic or abdominal surgery, pneumothorax, or history of spontaneous pneumothorax).
- Patients participating in other structured respiratory muscle training or pulmonary rehabilitation programs concurrently that could confound the results
- Patients undergoing other therapies that may affect diaphragmatic muscle measurement results, such as electrical diaphragmatic stimulation
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 |
|---|---|---|
| Threshold Inspiratory Muscle TrainingAlso: Inspiratory Muscle Training (IMT), Threshold IMTThreshold inspiratory muscle training performed using a threshold loading device to improve inspiratory muscle strength. Training is conducted once daily, five times per week for 6 weeks, with intensity starting at 30% and progressively increasing up to 50% of maximal inspiratory pressure (MIP) based on patient tolerance. | Other | Threshold Inspiratory Muscle Training |
| Philips Respironics Threshold IMT deviceA threshold loading device used to provide inspiratory resistance during inspiratory muscle training | Device | Threshold Inspiratory Muscle Training |
Primary outcome
Diaphragm Thickness (cm)
Time frame: Baseline to Week 6
Diaphragm thickness reflects the structural characteristics of the diaphragm muscle and is measured at end-inspiration and end-expiration using ultrasonography. The values are expressed in centimeters (cm).
Diaphragm Excursion (cm)
Time frame: Baseline to Week 6
Diaphragm excursion represents the vertical movement of the diaphragm during the respiratory cycle, reflecting diaphragmatic mobility and function. Measurements are obtained using ultrasonography and expressed in centimeters (cm).
3 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Baseline to Week 6
Forced Expiratory Volume in one second (FEV1)
Time frame: Baseline to Week 6
Peak Expiratory Flow (PEF)
Time frame: Baseline to Week 6
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 23 Apr 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.
Dian M. Sari, MD., M.Sc., Ph.D principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
Questions about this trial
What is this clinical trial studying?
A study testing Threshold Inspiratory Muscle Training and Philips Respironics Threshold IMT device in people with Chronic Obstructive Pulmonary Disease (COPD) and Diaphragm Dysfunction, run by Universitas Padjadjaran.
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 3 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dian M. Sari, MD., M.Sc., Ph.D (+62 812 2181 2279, dian.marta@unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickness (cm) (time frame: Baseline to Week 6). The study lists 2 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 23 Apr 2026.