Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

Not Applicable

Completed

• Conditions: PMV

• Registration Number: NCT05295381
• Lead Sponsor: Liu Shih Feng

Brief Summary

The patients with prolonged mechanical ventilation (PMV) have the risk of ineffective coughing and infection due to diaphragm weakness, making it more difficult to wean. This study aimed to explore the intervention of abdominal weight training (AWT) with/ without cough machine (CM) on lung function, respiratory muscle strength and cough ability in these patients.

Detailed Description

Methods 40 patients with PMV were randomly assigned to three groups: AWT group (n=12), AWT+CM group (n=14) and control group (n=14). The effectiveness on pulmonary function, respiratory muscle strength and cough ability were compared among these three groups.

Study Timeline

• Study Start: 2019-08-21
• Primary Completion: 2020-08-13
• Study Completion: 2020-08-13
• Study First Submitted: 2022-02-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-03-25
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• (1) Invasive ventilator users,
• (2) Hemodynamically stable,
• (3) Intubated endotracheal tube or tracheotomy tube,
• (4) Clearly conscious and cooperative,
• (5) Vital capacity (VC) <10ml/kg

Exclusion Criteria

• (1) Unconscious or unwilling to sign the informed consent form,
• (2) No spontaneous breathing,
• (3) Active bleeding with unstable hemodynamics,
• (4) Acute infection symptoms,
• (5) Abdominal distension, digestion problems (including nausea and vomiting),
• (6) Severe heart failure (ejection fraction ≤ 30%),
• (7) Unhealed wounds in the chest and abdomen,
• (8) Bullous emphysema,
• (9) Sensitive pneumothorax or mediastinal pneumothorax,
• (10) Recent history of traumatic stress,
• (11) Acute head and neck injury (unless the injury site is immobilized)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Maximum inspiratory pressure change by the intervention	Change between 1 day before and 2 weeks after the intervention	lung function
Maximum expiratory pressure change by the intervention	Change between 1 day before and 2 weeks after the intervention	lung function

Secondary Outcome Measures

Name	Time	Method
vital capacity change by the intervention	Change between 1 day before and 2 weeks after the intervention	lung function

Trial Locations

Locations (1)

Chang Gung Medical Foundation; 🇨🇳 Taipei, Taiwan