The Impact of Inspiratory Muscle Strength Training

NCT ID: NCT03997214

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

Ventilator Dependency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Control group

as usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental group

The intervention of inspiratory muscle strength training

Group Type: EXPERIMENTAL

inspiratory muscle strength training

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fooyin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiao-Yun Chang, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Fooyin

Locations

Shinghou Hospital

Kaohsiung City, Fengshan, Taiwan

Countries

Taiwan

Other Identifiers

108001

Identifier Type: -

Identifier Source: org_study_id