Skip to content

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03919513
Enrollment
30
Registered
2019-04-18
Start date
2019-05-01
Completion date
2022-05-01
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Rehabilitation

Keywords

IMT,NPPV,Pulmonary rehabilitation

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.

Interventions

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.

Sponsors

Zhujiang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Respiratory muscle strength(composite outcome measure)Change from baseline to 8 weeksCurrently, 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

MeasureTime frameDescription
Diaphragmatic functionChange from baseline to 8 weeksDiaphragmatic 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.
Symptom Evaluation(composite outcome measure)Change from baseline to 8 weeksIndividuals 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).
Pulmonary function(composite outcome measure)Change from baseline to 8 weeksPulmonary 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.
Exercise capacityChange from baseline to 8 weeksExercise capacity is evaluated using the 6-min walking distance (6MWD) according to American Thoracic Society guidelines.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026