Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

Not Applicable

Completed

• Conditions: PMV
• Interventions: Device: cough machine (CM); Device: abdominal weight training (AWT)

• 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

Arm && Interventions

Group	Intervention	Description
abdominal weight training with cough machine (CM)	abdominal weight training (AWT)	abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily. Cough machine training is based on the cough assist machine Comfort Cough II (CC20), in which the inhalation and exhalation times are adjusted to 1-3 seconds, and the positive and negative pressure of the lower pressure 10-15 cmH2O is gradually increased to 30-40 cmH2O for the first time, 4-6 cycles/time, repeated 4-6 times, twice a day, five days a week, until the subject is weaned off the ventilator or transferred out of the ward. A modified Borg scale was used as an indicator of perceived dyspnea.
abdominal weight training (AWT) without cough machine (CM)	abdominal weight training (AWT)	abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily.
abdominal weight training with cough machine (CM)	cough machine (CM)	abdominal weight exercise training (sandbag) is maintained for 30 minutes; the starting weight is 1kg to 2kg, and the previous day's weight is maintained each day as well as adding 0.5kg daily. Cough machine training is based on the cough assist machine Comfort Cough II (CC20), in which the inhalation and exhalation times are adjusted to 1-3 seconds, and the positive and negative pressure of the lower pressure 10-15 cmH2O is gradually increased to 30-40 cmH2O for the first time, 4-6 cycles/time, repeated 4-6 times, twice a day, five days a week, until the subject is weaned off the ventilator or transferred out of the ward. A modified Borg scale was used as an indicator of perceived dyspnea.

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