Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD

• ClinicalTrials.gov Identifier: NCT03919513
• Recruitment Status: Unknown
• First Posted: April 18, 2019
• Last Update Posted: April 18, 2019
• Sponsor: Zhujiang Hospital
• Information provided by (Responsible Party): Zhujiang Hospital

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Pulmonary Rehabilitation	Device: inspiratory pressure threshold device	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Effect of Combined Inspiratory Muscle Training and Continuous Positive Airway Pressure in Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease.
• Estimated Study Start Date: May 1, 2019
• Estimated Primary Completion Date: May 1, 2019
• Estimated Study Completion Date: May 1, 2019

Arms and Interventions

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 Name: 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 Name: CPAP

Outcome Measures

Primary Outcome Measures :

1. Respiratory muscle strength(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
   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.

Secondary Outcome Measures :

1. Diaphragmatic function [ Time Frame: Change from baseline to 8 weeks ]
   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.
2. Symptom Evaluation(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
   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).
3. Pulmonary function(composite outcome measure) [ Time Frame: Change from baseline to 8 weeks ]
   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.
4. Exercise capacity [ Time Frame: Change from baseline to 8 weeks ]
   Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

China, Guangdong

Zhujiang Hospital,Southern Medical Universicity

Guangzhou, Guangdong, China, 510282

Sponsors and Collaborators

Zhujiang Hospital

Investigators

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

More Information

• Responsible Party: Zhujiang Hospital
• ClinicalTrials.gov Identifier: NCT03919513
• Other Study ID Numbers: 2018-HXNK-011
• First Posted: April 18, 2019
• Last Update Posted: April 18, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Zhujiang Hospital:

IMT,NPPV,Pulmonary rehabilitation