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NCT Number: NCT07539974

Effect of Inspiratory Muscle Training on Diaphragm Function in COPD 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).

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Diaphragm Dysfunction Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Threshold Inspiratory Muscle Training

Other

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.

Other names: Inspiratory Muscle Training (IMT), Threshold IMT

Philips Respironics Threshold IMT device

Device

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Forced Vital Capacity (FVC)

    Time frame: Baseline to Week 6

    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.

  2. Forced Expiratory Volume in one second (FEV1)

    Time frame: Baseline to Week 6

    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.

  3. Peak Expiratory Flow (PEF)

    Time frame: Baseline to Week 6

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dian M. Sari, MD., M.Sc., Ph.D

CONTACT

[email protected]

+62 812 2181 2279

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Collaborators

  • Hasan Sadikin General Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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