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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Diaphragm Dysfunction
• Intervention / Treatment: Other: Threshold Inspiratory Muscle Training; Device: Philips Respironics Threshold IMT device

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dian M. Sari, MD., M.Sc., Ph.D; Phone Number: +62 812 2181 2279; Email: dian.marta@unpad.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Threshold Inspiratory Muscle Training

Other: Threshold 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.; Other Names: Threshold IMT; Inspiratory Muscle Training (IMT); Device: Philips Respironics Threshold IMT device; A threshold loading device used to provide inspiratory resistance during inspiratory muscle training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline to Week 6

Collaborators and Investigators

• Sponsor: Universitas Padjadjaran
• Collaborators: Dr. Hasan Sadikin General Hospital, Bandung, Indonesia
• Investigators: Principal Investigator: Dian M. Sari, MD., M.Sc., Ph.D, Faculty of Medicine Universitas Padjadjaran Bandung

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: IKFR-202604.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No