Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD

Effect of Combined Inspiratory Muscle Training and Continuous Positive Airway Pressure in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease.

Inspiratory muscle training(IMT) was one of the widely used pulmonary rehabilitation method in COPD patients.However, when the respiratory muscles are fatigue without sufficient rest, IMT may increase muscle fatigue and aggravate muscle damage. Noninvasive positive pressure ventilation (NPPV) is another important strategy of pulmonary rehabilitation which could overcome airway resistance and reduce respiratory work, improve respiratory muscle fatigue. Therefore, the purpose of this study was to explore the effective of the "IMT - NPPV sequential" rehabilitation method, that is, first inspiratory muscle training, followed by respiratory muscle resting (non-invasive positive pressure ventilation).

Study Overview

• Status: Completed
• Conditions: Pulmonary Rehabilitation
• Intervention / Treatment: Device: inspiratory pressure threshold device

Detailed Description

Exploring the effects of the new rehabilitation method of "IMT - NPPV sequential", comparing with the single rehabilitation strategy such as inspiratory muscle training and non-invasive positive pressure ventilation.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Zhujiang Hospital,Southern Medical Universicity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

• Patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed.

Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: respiratory muscle weakness; Patients with respiratory muscle weakness are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.	Device: inspiratory pressure threshold device; The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.; Other Names: CPAP
Experimental: normal respiratory muscle; Patients with normal respiratory muscle are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.	Device: inspiratory pressure threshold device; The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.; Other Names: CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory muscle strength(composite outcome measure)	Currently, the maximal inspiratory pressure (PImax) and maximal expiratory pressures(PEmax) are measured by a digital manometer (AZ-8205, AZ Instrument, Taichung City, Taiwan)and combined to evaluate respiratory muscle function.	Change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragmatic function	Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi) measured by a high-performance data acquisition device (Powerlab 16/35; ADInstruments, Australia), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.	Change from baseline to 8 weeks
Symptom Evaluation(composite outcome measure)	Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness, and psychological distress. Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).	Change from baseline to 8 weeks
Pulmonary function(composite outcome measure)	Pulmonary function is measured using a spirometer(PonyFX 229, Cosmed, Rome, Italy) that is calibrated daily.The FEV1 and percent-of-predicted FEV1, FVC and percent-of-predicted FVC which are presented in one report are used to evaluate Pulmonary Function.	Change from baseline to 8 weeks
Exercise capacity	Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.	Change from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Principal Investigator: Chen Xin, Doctor, Zhujiang Hospital,Southern Medical Unversity

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: IMT,NPPV,Pulmonary rehabilitation
• Other Study ID Numbers: 2018-HXNK-011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes