- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04822831
The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients
The Effect of 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients
Study Overview
Status
Detailed Description
Background: Prolonged mechanical ventilation patients rely on medical expenses per year had increased by nearly 20 billion in 15 years. However, the high cost shows the high morbidity rate, high mortality rate and low ventilator weaning rate of prolonged mechanical ventilation patients, so it is worthwhile to explore how to improve the respiratory function and even their quality of life of patients in the respiratory care ward (RCW).
OBJECTIVE: To investigate the improvement of respiratory function and the effect of respirator detachment in 45-degree semi-sitting and upper limb training, and to understand the correlation between this training activity and death risk.
METHODS: This study used repeated experimental measurements and purpose sampling, and the investigators invited patients in the respiratory care ward (RCW) in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting 2hrs and upper-limb exercise training 10mins once a day. After 4 weeks, the investigators measure the respiratory parameters such as the maximum inspiratory pressure (MIP), the tidal volume (VT), the minute ventilation (MV), and the rapid shallow breathing index(RSBI) of these two groups, and used the generalized estimating equation (GEE) to compare with them.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Longtan Dist.
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Taoyuan, Longtan Dist., Taiwan, 325
- Se-Hua Lin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- respiratory care ward (RCW) cases using mechanical ventilators
- 20 years old ≦ age ≦ 89 years old
- Those who used antibiotics without infection and fever (body temperature >38.5℃) in the past 3 days
- the fraction of inspiration O2(FiO2)≦50% and the positive end expiratory pressure(PEEP)≦10
- 90 mm-Hg≦ systolic blood pressure(SBP) ≦160 mm-Hg
- 60 beats/min≦ heart rate(HR) ≦130 beats/min without arrhythmia
- 12 times/min≦ respiratory rate(RR) ≦35 times/min
- 90%≦ oxygen saturation by pulse oximetry (SPO2) ≦100%
- Patients with spontaneous breathing
- Digestible without continuous feeder
Exclusion Criteria:
- respiratory care ward (RCW) cases without mechanical ventilators
- Age <20 years old or age>89 years old
- Those who have been infected with fever in the past 3 days (body temperature >38.5℃) and are taking antibiotic
- the fraction of inspiration O2(FiO2) >50% and the positive end expiratory pressure(PEEP)>10
- systolic blood pressure(SBP)< 90 mm-Hg or systolic blood pressure(SBP) >160 mm-Hg
- heart rate(HR)<60 beats/min or heart rate(HR)>130 beats/min and arrhythmia
- respiratory rate(RR)<12 times/minute or respiratory rate(RR)>35 times/minute
- oxygen saturation by pulse oximetry (SPO2) <90%
- Patients without spontaneous breathing
- Poor digestion and use of continuous feeders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Long-term Ventilator-dependent Patients with intervention
45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients
|
The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day, and this intervention kept 4 weeks.
Other Names:
|
Experimental: Long-term Ventilator-dependent Patients without intervention
There is no intervention on Long-term Ventilator-dependent Patients ,and just keep routine treatment.
|
The control group was with usual treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximum inspiratory pressure (MIP)
Time Frame: Change from maximum inspiratory pressure (MIP) at 1 month
|
After doing intervention for 4 weeks, we measure the maximum inspiratory pressure (MIP) of these two groups
|
Change from maximum inspiratory pressure (MIP) at 1 month
|
tidal volume (VT)
Time Frame: Change from tidal volume (VT) at 1 month
|
After doing intervention for 4 weeks, we measure the tidal volume (VT) of these two groups
|
Change from tidal volume (VT) at 1 month
|
minute ventilation (MV)
Time Frame: Change from minute ventilation (MV) at 1 month
|
After doing intervention for 4 weeks, we measure the minute ventilation (MV) of these two groups
|
Change from minute ventilation (MV) at 1 month
|
rapid shallow breathing index (RSBI)
Time Frame: Change from rapid shallow breathing index (RSBI) at 1 month
|
After doing intervention for 4 weeks, we measure the rapid shallow breathing index (RSBI) of these two groups
|
Change from rapid shallow breathing index (RSBI) at 1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Se-Hua Lin, master, Taoyuan Armed Forces General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SeHLin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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