The Effect of Semi-recumbent Position With Exercise Training on Long-term Ventilator-dependent Patients

March 29, 2021 updated by: Se-Hua Lin, Taoyuan General Hospital

The Effect of 45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients

Prolonged mechanical ventilation patients rely on medical expenses per year had increased by nearly 20 billion in 15 years, so it is worthwhile to explore how to improve the respiratory function and even their quality of life of patients in Respiratory care wards (RCWs). This study used repeated experimental measurements and purpose sampling, and the investigators invited patients in respiratory care ward in northern Taiwan. They were randomly assigned to the experimental group and the control group. The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day. There were 29 prolonged mechanical ventilation (PMV) patients in the experimental group and 26 in the control group. Our conclusions showed that PMV patients can significantly improve the maximum inspiratory pressure (MIP) in the post-test while performed a 45-degree semi-sitting position with upper limb training for 4 weeks. The minute ventilation (MV) has a trend of increasing month by month in the experimental group, but it is necessary to consider whether it is due to the improvement of lung function or just cause of the increased oxygen consumption and accelerated respiratory rate, so it can not be inferred to improvement of the patient's condition or lung function.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Longtan Dist.
      • Taoyuan, Longtan Dist., Taiwan, 325
        • Se-Hua Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Long-term Ventilator-dependent Patients with intervention
45 Degree Semi-recumbent Position With Upper Limb Exercise Training on Long-term Ventilator-dependent Patients
Behavioral: 45 Degree Semi-recumbent Position With Upper Limb Exercise Training
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:
  • 45 Degree Semi-sitting Position With Upper Limb Exercise Training
Experimental: Long-term Ventilator-dependent Patients without intervention
There is no intervention on Long-term Ventilator-dependent Patients ,and just keep routine treatment.
Behavioral: no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training
The control group was with usual treatment.
Other Names:
  • no other intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taoyuan General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Se-Hua Lin, master, Taoyuan Armed Forces General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SeHLin

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

we don't plan to make individual participant data (IPD) ,because the database belonged to patients and hospitals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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