Transdiaphragmatic Pressure and Neural Respiratory Drive Measured During Inspiratory Muscle Training in COPD

NCT03017300 | Completed DMC

• 2 other identifiers: GuangzhouInRDGuangzhouIntRD
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inspiratory muscle training（IMT）was an rehabilitation therapy for stable patients with chronic obstructive pulmonary disease(COPD). However, its therapeutic effect remains undefined due to unclear of diaphragmatic mobilization during IMT. Diaphragmatic mobilization represented by transdiaphragmatic pressure（Pdi）and neural respiratory drive expressed as corrective root-mean-square(RMS) of diaphragmatic electromyogram(EMGdi) provide vital information to select the proper IMT device and loads in COPD, therefore make curative effect of IMT clarity. Pdi and RMS of diaphragmatic electromyogram (RMSdi%) was respectively measured and compared during inspiratory resistive training and threshold load training in stable patients of COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• transdiaphragmatic pressure

  half an hour

Secondary Outcomes (1)

• neural respiratory drive

  half an hour

Study Arms (2)

COPD（threshold IMT training）

EXPERIMENTAL

COPD patient use Inspiratory muscle trainer (Threshold IMT®)

Device: Threshold IMT®

COPD（resisive training）

EXPERIMENTAL

COPD patient use Inspiratory muscle trainer (PFLEX®)

Device: PFLEX®

Interventions

Threshold IMT® DEVICE

A device used to offer threshold load to inspiratory muscle

Also known as: inspiratory threshold load inspiratory muscle training

COPD（threshold IMT training）

PFLEX® DEVICE

A device used to offer resisive to inspiratory muscle

Also known as: inspiratory resisive inspiratory muscle training

COPD（resisive training）

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group);
• Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O）;
• Bronchial dilation test (BDT) negative

You may not qualify if:

• acute exacerbation in the previous 4 weeks;
• using the oral corticosteroids within 4 weeks;
• history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

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

• Rongchang Chen, Master

  Guangzhou Institude of Respiratory Disease

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01