Effect of Combined IMT and CPAP in Pulmonary Rehabilitation for COPD

NCT03919513 | Completed DMC

• 1 other identifier: 2018-HXNK-011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Rehabilitation

Keywords

IMT,NPPV,Pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Diaphragmatic function

  Change from baseline to 8 weeks

• Symptom Evaluation(composite outcome measure)

  Change from baseline to 8 weeks

• Pulmonary function(composite outcome measure)

  Change from baseline to 8 weeks

• Exercise capacity

  Change from baseline to 8 weeks

Study Arms (2)

respiratory muscle weakness

EXPERIMENTAL

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

normal respiratory muscle

EXPERIMENTAL

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

Interventions

inspiratory pressure threshold device 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.

Also known as: CPAP

normal respiratory muscle; respiratory muscle weakness

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital,Southern Medical Universicity

Guangzhou, Guangdong, 510282, China

Location

Study Officials

• Chen Xin, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 18, 2019
• Study Start: May 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: May 1, 2022
• Last Updated: March 13, 2024

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)