PMVNCT05295381
Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function
A study testing cough machine (CM) and abdominal weight training (AWT) in people with PMV, run by Liu Shih Feng at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 57 to 84 years
- Conditions the study is for
- PMV
- What is being tested?
- cough machine (CM) and abdominal weight training (AWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Aug 2019to 13 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 57 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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%),
Show all 11Show fewer
- (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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function in the Patients With Prolonged Mechanical Ventilation
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.
Read the 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.
- Conditions
- PMV
- Being tested
- cough machine (CM), abdominal weight training (AWT)
- Keywords
- prolonged mechanical ventilation, weaning ventilator, abdominal weight training, cough machine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cough machine (CM)Device
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)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| abdominal weight training with cough machine (CM) | Experimental | 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. Receives: Device: cough machine (CM); Device: abdominal weight training (AWT) |
| abdominal weight training (AWT) without cough machine (CM) | Experimental | 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. Receives: Device: abdominal weight training (AWT) |
| control | No intervention | no abdominal weight training and no cough machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum inspiratory pressure change by the intervention
lung function
Measured: Change between 1 day before and 2 weeks after the intervention
Maximum expiratory pressure change by the intervention
lung function
Measured: Change between 1 day before and 2 weeks after the intervention
Secondary outcomes (1)
vital capacity change by the intervention
lung function
Measured: Change between 1 day before and 2 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start21 Aug 2019
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PMVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- AWT group (n=12), AWT+CM group (n=14) control group (n=14).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liu Shih Feng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Shih Feng, Chang Gung Memorial Hospital
- Investigators
- Tsang-Tang Hsieh, Study chair, Institutional Review Board Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295381
- Sponsor's protocol ID
- 201900885B0A3
- Status last verified
- Mar 2022
- First submitted
- 18 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SM, Choi WA, Won YH, Kang SW. A Comparison of Cough Assistance Techniques in Patients with Respiratory Muscle Weakness. Yonsei Med J. 2016 Nov;57(6):1488-93. doi: 10.3349/ymj.2016.57.6.1488.
PubMed 27593879Lacombe M, Del Amo Castrillo L, Bore A, Chapeau D, Horvat E, Vaugier I, Lejaille M, Orlikowski D, Prigent H, Lofaso F. Comparison of three cough-augmentation techniques in neuromuscular patients: mechanical insufflation combined with manually assisted cough, insufflation-exsufflation alone and insufflation-exsufflation combined with manually assisted cough. Respiration. 2014;88(3):215-22. doi: 10.1159/000364911. Epub 2014 Aug 21.
PubMed 25171575Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.
PubMed 11359958Hung TY, Wu WL, Kuo HC, Liu SF, Chang CL, Chang HC, Tsai YC, Liu JF. Effect of abdominal weight training with and without cough machine assistance on lung function in the patients with prolonged mechanical ventilation: a randomized trial. Crit Care. 2022 May 25;26(1):153. doi: 10.1186/s13054-022-04012-1.
PubMed 35614518
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Abdominal Weight Training Assisted by Cough Assist Machine on Lung Function in the Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05295381
- Acronym / sponsor ID
- 201900885B0A3
- Conditions
- PMV
- Keywords
- prolonged mechanical ventilation, weaning ventilator, abdominal weight training, cough machine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Liu Shih FengUniversity, hospital or other
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- AWT group (n=12), AWT+CM group (n=14) control group (n=14).
| Arm | Type | Receives |
|---|---|---|
| abdominal weight training with cough machine (CM) | Experimental | Device: cough machine (CM), Device: 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) | Experimental | Device: 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. |
| control | No intervention | –no abdominal weight training and no cough machine |
Who may qualify
- Ages
- 57 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (11 listed)
- (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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cough machine (CM)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 | 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. | Device | abdominal weight training (AWT) without cough machine (CM), abdominal weight training with cough machine (CM) |
Primary outcome
Maximum inspiratory pressure change by the intervention
Time frame: Change between 1 day before and 2 weeks after the intervention
lung function
Maximum expiratory pressure change by the intervention
Time frame: Change between 1 day before and 2 weeks after the intervention
lung function
1 secondary outcome
vital capacity change by the intervention
Time frame: Change between 1 day before and 2 weeks after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Results publication: PubMed 27593879Kim SM, Choi WA, Won YH, Kang SW. A Comparison of Cough Assistance Techniques in Patients with Respiratory Muscle Weakness. Yonsei Med J. 2016 Nov;57(6):1488-93. doi: 10.3349/ymj.2016.57.6.1488.
- Results publication: PubMed 25171575Lacombe M, Del Amo Castrillo L, Bore A, Chapeau D, Horvat E, Vaugier I, Lejaille M, Orlikowski D, Prigent H, Lofaso F. Comparison of three cough-augmentation techniques in neuromuscular patients: mechanical insufflation combined with manually assisted cough, insufflation-exsufflation alone and insufflation-exsufflation combined with manually assisted cough. Respiration. 2014;88(3):215-22. doi: 10.1159/000364911. Epub 2014 Aug 21.
- Results publication: PubMed 11359958Sivasothy P, Brown L, Smith IE, Shneerson JM. Effect of manually assisted cough and mechanical insufflation on cough flow of normal subjects, patients with chronic obstructive pulmonary disease (COPD), and patients with respiratory muscle weakness. Thorax. 2001 Jun;56(6):438-44. doi: 10.1136/thorax.56.6.438.
- Derived from this study: PubMed 35614518Hung TY, Wu WL, Kuo HC, Liu SF, Chang CL, Chang HC, Tsai YC, Liu JF. Effect of abdominal weight training with and without cough machine assistance on lung function in the patients with prolonged mechanical ventilation: a randomized trial. Crit Care. 2022 May 25;26(1):153. doi: 10.1186/s13054-022-04012-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tsang-Tang Hsieh study chair
Institutional Review Board Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cough machine (CM) and abdominal weight training (AWT) in people with PMV, run by Liu Shih Feng at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum inspiratory pressure change by the intervention (time frame: Change between 1 day before and 2 weeks after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05295381, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.