The Respiratory Physiology Variation of COPD Patients in Inspiratory Muscle Training

NCT02278523 | Completed Phase 2 DMC

• 1 other identifier: GuangzhouIRD
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Background：Respiratory muscle weakness is observed in chronic obstructive pulmonary disease(COPD) patients and contributes to hypercapnia, dyspnoea, nocturnal oxygen desaturation and reduced walking distance.During exercise it has been shown that diaphragm work is increased in COPD and COPD patients use a larger proportion of the maximal inspiratory pressure (MIP) than healthy subjects. This pattern of breathing is closely related to the dyspnoea sensation during exercise and might potentially induce respiratory muscle fatigue. Inspiratory muscle training(IMT) increases inspiratory muscle strength and endurance, and decreases dyspnoea.But the mechanism of IMT still lack of research. Purpose：The experiment is aim to compare of the similarities and differences of transdiaphragmatic pressure by detecting the transdiaphragmatic pressure of COPD patients and healthy volunteers in different intensity of threshold load conditions. Thus investigate how inspiratory muscle training works or mechanism in lung rehabilitation programmes of COPD.And emerging the theoretical basis of inspiratory muscle training from respiratory physiological mechanism.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Transdiaphragmatic pressure

  measure the transdiaphragmatic pressure while spontaneous breathing

  half an hour

Study Arms (2)

Inspiratory muscle training group

EXPERIMENTAL

COPD patient use Inspiratory muscle trainer (Threshold IMT®)

Device: Threshold IMT®

control group

ACTIVE COMPARATOR

normal volunteers use Inspiratory muscle trainer(Threshold IMT®)

Device: Threshold IMT®

Interventions

Threshold IMT® DEVICE

A device used to offer threshold load to inspiratory muscle

Also known as: threshold inspiratory muscle trainer

Inspiratory muscle training group; control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• 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
• Inspiratory muscle weakness（Maximal Inspiratory Pressure under 60cmH2O.
• Bronchial dilation test(BDT) negative.

You may not qualify if:

• Suffer from acute exacerbation less than 4 weeks.
• Intravenous or oral corticosteroids in 4 weeks.
• With other heart, lung and brain disorders.
• With poor compliance.

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Respiratory muscle training device

Guangzhou, Guangdong, 510000, China

Location

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

• Chen Rongchang, Master

  Guangzhou Institude of Respiratory Disease

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangzhou Institute of Respiratory Disease

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 30, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

CN (1)