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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: Threshold IMT®; Device: PFLEX®

Detailed Description

Subjects：The diagnosis and severity of all participants were measured using the pulmonary function test according to Global Initiative for Chronic Obstructive Lung Disease.

Inclusion criteria: (1)Severe and very severe COPD (postbronchodilator FEV1/FVC under 70% and FEV1 under 50% of the predicted value (GOLD C and D group); (2)Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O）; (3) Bronchial dilation test (BDT) negative.

Exclusion criteria: (1) acute exacerbation in the previous 4 weeks; (2) using the oral corticosteroids within4 weeks; (3) history of other respiratory, cardiovascular, neuromuscular, musculoskeletal diseases that could interfere the study.

Study design This was a single-centre, cross-sectional study.

Intervention： Inspiratory resistive training All participants conducted inspiratory resistive training using inspiratory resistive trainer (PFLEX, Respironics Inc, USA). Pdi and EMGdi were recorded synchronously.Inspiratory resistive load was change from low intensity into moderate and high intensity randomly（inspiratory hole diameters was set to 5.3mm, 2.4mm and 1.8mm,respectively）

Inspiratory threshold load training Inspiratory threshold load training was conducted by all participants using the inspiratory threshold load trainer (Threshold Inspiration Muscle Trainer, Respironics Inc, USA) .Inspiratory threshold pressure was set to low, medium and high intensity randomly（threshold pressure was 30%,60% and 80% of MIP, respectively).

Measurements ：transdiaphragmatic pressure and neural respiratory drive

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD（threshold IMT training）; COPD patient use Inspiratory muscle trainer (Threshold IMT®)	Device: Threshold IMT®; A device used to offer threshold load to inspiratory muscle; Other Names: inspiratory threshold load inspiratory muscle training
Experimental: COPD（resisive training）; COPD patient use Inspiratory muscle trainer (PFLEX®)	Device: PFLEX®; A device used to offer resisive to inspiratory muscle; Other Names: inspiratory resisive inspiratory muscle training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
transdiaphragmatic pressure	half an hour

Secondary Outcome Measures

Outcome Measure	Time Frame
neural respiratory drive	half an hour

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Study Chair: Rongchang Chen, Master, Guangzhou Institude of Respiratory Disease

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 10, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: GuangzhouInRD; GuangzhouIntRD (Other Identifier: Guangzhou Institute of Respiratory Disease)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED