Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD
- Conditions
- Pulmonary Rehabilitation
- Interventions
- Device: inspiratory pressure threshold device
- Registration Number
- NCT03919513
- Lead Sponsor
- Zhujiang Hospital
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description respiratory muscle weakness inspiratory pressure threshold device Patients with respiratory muscle weakness are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly. normal respiratory muscle inspiratory pressure threshold device Patients with normal respiratory muscle are performing the inspiratory pressure threshold device, combined CPAP and inspiratory pressure threshold device and continue oxygen therapy randomly.
- Primary Outcome Measures
Name Time Method Respiratory muscle strength(composite outcome measure) 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
Name Time Method Exercise capacity Change from baseline to 8 weeks Exercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.
Pulmonary function(composite outcome measure) 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.
Symptom Evaluation(composite outcome measure) 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).
Diaphragmatic function 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.
Trial Locations
- Locations (1)
Zhujiang Hospital,Southern Medical Universicity
🇨🇳Guangzhou, Guangdong, China