Effect of Inspiratory Muscle Training on Diaphragm Function in COPD Patients

NCT07539974 | Not Yet Recruiting

• 1 other identifier: IKFR-202604.01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Diaphragm Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Baseline to Week 6

Secondary Outcomes (3)

• Forced Vital Capacity (FVC)

  Baseline to Week 6

• Forced Expiratory Volume in one second (FEV1)

  Baseline to Week 6

• Peak Expiratory Flow (PEF)

  Baseline to Week 6

Study Arms (1)

Threshold Inspiratory Muscle Training

EXPERIMENTAL

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

Interventions

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.

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

Threshold Inspiratory Muscle Training

Philips Respironics Threshold IMT device DEVICE

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

Threshold Inspiratory Muscle Training

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead
• Dr. Hasan Sadikin General Hospital, Bandung, Indonesia: collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dian M. Sari, MD., M.Sc., Ph.D

  Faculty of Medicine Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

+62 812 2181 2279; dian.marta@unpad.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-group assignment with pretest-posttest assessment. All participants receive threshold inspiratory muscle training, and outcomes are measured before and after the intervention.

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share