Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function in the Patients With Prolonged Mechanical Ventilation

Conditions
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PMV

Intervention / Treatment
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* Device: cough machine (CM)
* Device: abdominal weight training (AWT)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 57 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: AWT group (n=12), AWT+CM group (n=14) control group (n=14).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: abdominal weight training with cough machine (CM)<br>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. | Device: cough machine (CM)<br>* 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.<br>Device: abdominal weight training (AWT)<br>* 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.<br>|
| Experimental: abdominal weight training (AWT) without cough machine (CM)<br>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. | Device: abdominal weight training (AWT)<br>* 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.<br>|
| No Intervention: control<br>no abdominal weight training and no cough machine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspiratory pressure change by the intervention | lung function | Change between 1 day before and 2 weeks after the intervention | 
| Maximum expiratory pressure change by the intervention | lung function | Change between 1 day before and 2 weeks after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital capacity change by the intervention | lung function | Change between 1 day before and 2 weeks after the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged mechanical ventilation, weaning ventilator, abdominal weight training, cough machine