ClinicalTrials.gg
Not yet recruitingNCT07539974Updated Apr 23, 2026

Effect of Inspiratory Muscle Training on Diaphragm Function in COPD Patients

An interventional study of Threshold Inspiratory Muscle Training and Philips Respironics Threshold IMT device in Chronic Obstructive Pulmonary Disease (COPD) and Diaphragm Dysfunction, sponsored by Universitas Padjadjaran. Not yet recruiting. Open to participants aged 40 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Universitas Padjadjaran · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
40 Years to 59 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Diaphragm Dysfunction
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In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 15 is below the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Universitas Padjadjaran is the lead sponsor of 93 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a 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

Exclusion criteria

Exclusion Criteria:

  • Patients with 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Threshold Inspiratory Muscle Training

    Other: Threshold Inspiratory Muscle Training · Device: Philips Respironics Threshold IMT device

Interventions

  • OtherThreshold Inspiratory Muscle Training

    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.

    Also known as: Inspiratory Muscle Training (IMT), Threshold IMT

  • DevicePhilips Respironics Threshold IMT device

    A threshold loading device used to provide inspiratory resistance during inspiratory muscle training

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline to Week 6

  2. 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).

    Time frame: Baseline to Week 6

Secondary outcomes

  1. 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.

    Time frame: Baseline to Week 6

  2. 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.

    Time frame: Baseline to Week 6

  3. 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.

    Time frame: Baseline to Week 6

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Jun 2026, 2 months later.

Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 2 months is below that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 13, 2026
First posted
Apr 20, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
Jun 1, 2026
CompletionEst.
Sep 1, 2026
Last update
Apr 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07539974
Lead sponsor
Universitas Padjadjaran
Collaborators
Hasan Sadikin General Hospital
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Apr 23, 2026

Study contacts

Dian M. Sari, MD., M.Sc., Ph.D
Contact
dian.marta@unpad.ac.id
+62 812 2181 2279
Dian M. Sari, MD., M.Sc., Ph.D
principal investigator · Faculty of Medicine Universitas Padjadjaran Bandung

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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