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Not yet recruiting NCT07539974

Effect of Inspiratory Muscle Training on Diaphragm Function in COPD Patients

No phase Interventional Chronic Obstructive Pulmonary Disease (COPD) Diaphragm Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Threshold Inspiratory Muscle Training, Philips Respironics Threshold IMT device.
Who it may be relevant to
Registry conditions: Chronic Obstructive Pulmonary Disease (COPD), Diaphragm Dysfunction. Basic parameters: 40 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.
  • Device Philips Respironics Threshold IMT device
    A threshold loading device used to provide inspiratory resistance during inspiratory muscle training

Primary outcome measures

  • Diaphragm Thickness (cm) [Time frame: Baseline to Week 6]
  • Diaphragm Excursion (cm) [Time frame: Baseline to Week 6]
Secondary outcome measures (3)
  • Forced Vital Capacity (FVC) [Time frame: Baseline to Week 6]
  • Forced Expiratory Volume in one second (FEV1) [Time frame: Baseline to Week 6]
  • Peak Expiratory Flow (PEF) [Time frame: Baseline to Week 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07539974 · IKFR-202604.01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗