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Effect of Inspiratory Muscle Training on Diaphragm Function in COPD Patients

Effect of Threshold Inspiratory Muscle Training on Diaphragm Thickness and Diaphragm Excursion Value in Chronic Obstructive Pulmonary Disease Patients

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07539974
Enrollment
15
Registered
2026-04-20
Start date
2026-04-01
Completion date
2026-09-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD), Diaphragm Dysfunction

Brief 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).

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.

Interventions

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.

DEVICEPhilips Respironics Threshold IMT device

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

Sponsors

Universitas Padjadjaran
Lead SponsorOTHER
Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 59 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragm Thickness (cm)Baseline to Week 6Diaphragm 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)Baseline to Week 6Diaphragm 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).

Secondary

MeasureTime frameDescription
Forced Vital Capacity (FVC)Baseline to Week 6Forced 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.
Forced Expiratory Volume in one second (FEV1)Baseline to Week 6Forced 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.
Peak Expiratory Flow (PEF)Baseline to Week 6Peak 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.

Contacts

CONTACTDian M. Sari, MD., M.Sc., Ph.D
dian.marta@unpad.ac.id+62 812 2181 2279
PRINCIPAL_INVESTIGATORDian M. Sari, MD., M.Sc., Ph.D

Faculty of Medicine Universitas Padjadjaran Bandung

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026