The Impact of Inspiratory Muscle Strength Training (IMT)

June 21, 2019 updated by: Fooyin University

The Impact of Inspiratory Muscle Strength Training on Weaning Parameters Among Ventilator-dependent Patients

The study is a pre-post test with quasi experimental design. Forty-two intubated-adults who had been mechanically ventilated for more than 21 days were selected on the basis of inclusion criteria in respiratory care ward. These patients were classified equally into study group and control group. The experimental group received the intervention of respiratory muscles training 5 times/ a week for 6 weeks. The control group received normal care. The intervention was adjusted trigger sensitivity to 10% of the first recorded Maximal Inspiratory Pressure at the start of training, then increased the ventilator trigger sensitivity and training duration weekly. The largest of ventilator trigger sensitivity is not over 40% of the initial Maximal Inspiratory Pressure and the timing of training duration is no longer than 30 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • 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
    • Fengshan
      • Kaohsiung, Fengshan, Taiwan, 830
        • Shinghou Hospital

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >20y/o
  • Vital signs stable
  • MIP <20cmH2O
  • Ventilator FiO2<40%, PEEP <8
  • Ventilator mode:PSV or SIMV

Exclusion Criteria:

  • Patient or family refuse

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
as usual care
Experimental: experimental group
The intervention of inspiratory muscle strength training
Device: inspiratory muscle strength training
The experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal inspiratory pressure
Time Frame: 7 weeks
a measure of the strength of inspiratory muscles, measurement by cmH2O.
7 weeks
Tidal volume
Time Frame: 7 weeks
the volume of air that is transported into and out of the lungs with each respiratory cycle, measurement by mL per inspiration
7 weeks
Minute ventilation volume
Time Frame: 7 weeks
the quantity of air moved into and out of the lungs in a minute, measurement by l.min
7 weeks
Rapid shallow breathing index
Time Frame: 7 weeks
the ratio of respiratory frequency to tidal volume (f/VT)
7 weeks
Oxygenation index.
Time Frame: 7 weeks
Oxygenation index OI = FiO2 x 100 x M AP/PaO2, where FiO2 is the fraction of inspired oxygen, MAP is the mean airway pressure, and PaO2 is the partial pressure of oxygen in arterial blood, calculated at the end of the first day of standardized preoperative stabilization
7 weeks

Collaborators and Investigators

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

Sponsor

Fooyin University

Investigators

  • Principal Investigator: Hsiao-Yun Chang, Ph.D, Fooyin

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)

June 15, 2018

Primary Completion (Actual)

December 30, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 21, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

June 25, 2019

Last Update Submitted That Met QC Criteria

June 21, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 108001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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