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

NCT ID: NCT03017300

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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.

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

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

COPD（threshold IMT training）

COPD patient use Inspiratory muscle trainer (Threshold IMT®)

Group Type: EXPERIMENTAL

Threshold IMT®

Intervention Type: DEVICE

A device used to offer threshold load to inspiratory muscle

COPD（resisive training）

COPD patient use Inspiratory muscle trainer (PFLEX®)

Group Type: EXPERIMENTAL

PFLEX®

Intervention Type: DEVICE

A device used to offer resisive to inspiratory muscle

Interventions

Threshold IMT®

A device used to offer threshold load to inspiratory muscle

Intervention Type: DEVICE

PFLEX®

A device used to offer resisive to inspiratory muscle

Intervention Type: DEVICE

Other Intervention Names

inspiratory threshold load inspiratory muscle training; inspiratory resisive inspiratory muscle training

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Weiliang Wu

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rongchang Chen, Master

Role: STUDY_CHAIR

Guangzhou Institude of Respiratory Disease

Other Identifiers

GuangzhouIntRD

Identifier Type: OTHER

Identifier Source: secondary_id

GuangzhouInRD

Identifier Type: -

Identifier Source: org_study_id