NCT06611683

Brief Summary

The goal of this clinical trial is to learn if inspiratory muscle training facilite the liberation of mechanical ventilation. The main questions it aims to answer are: Does inspiratory muscle training facilitate weaning from mechanical ventilation and enhance muscle strength in critically ill, subacute adult patients? The main questions it aims to answer are: Does pulmonary rehabilitation facilitate wwaning form mechanical patients? Does the intervention improve respiratory muscle strength and respiratory patterns? Participants received: Inspriatory muscle training twice daily for three consecutive weeks or until the subject no longer required ventilator support.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
Last Updated

October 3, 2024

Status Verified

September 1, 2024

Enrollment Period

1.5 years

First QC Date

September 22, 2024

Last Update Submit

October 1, 2024

Conditions

Critically Ill, Subacute Adult PatientsMechanically Ventilation

Keywords

sub-acute critical illmechanical ventilationrespiratory muscle trainingrespiratory muscle strengthrapid shallow breathing index

Outcome Measures

Primary Outcomes (1)

  • Number of days until liberation from mechanical ventilation

    A record of the number of days until liberation from mechanical ventilation.

    Three weeks

Secondary Outcomes (5)

  • Maximum inspiratory pressure

    Three weeks

  • Maximum expiratory pressure

    Three weeks

  • Peak expiratory flow

    Three weeks

  • Peak inspiratory flow

    Three weeks

  • Rapid Shallow breathing index

    Three weeks

Study Arms (2)

Inspiratory Muscle Training

EXPERIMENTAL

Subjects received inspiratory muscle training twice daily over five consecutive days, followed by a two-day rest period. This regimen was continued for three consecutive weeks or until the subject no longer required ventilator support.

Procedure: Inspiratory muscle training

Non-inspiratory muscle training

SHAM COMPARATOR

Subjects received routine care.

Procedure: Routine care

Interventions

Inspiratory muscle trainingPROCEDURE

A threshold inspiratory muscule device used a starting resistance set at 30% maximum inspiratory pressure, connecting to subject artificial airway. The subjects were then instructed to perform fast and forceful inspirations against added inspiratory resistance. The inspiratory muscle training was conducted twice daily over five consecutive days, followed by a two-day rest period. This regimen continued for three consecutive weeks or until the subject no longer required ventilator support.

Inspiratory Muscle Training
Routine carePROCEDURE

Subjects received routine care without intervention.

Non-inspiratory muscle training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • requiring invasive mechanical ventilation for 2 days in an ICU

You may not qualify if:

  • hemodynamic instability (heart rate 120 beats/min, unstable blood pressure, vasopressor infusion)
  • inadequate oxygenation (PEEP 8 cmH2O, FiO2 50%)
  • body temperature 38.5°C
  • sepsis
  • use of sedative infusion
  • steroid administration
  • home ventilator use before ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zuoying Armed Forces General Hospital

Kaohsiung City, Taiwan

Location

Related Publications (1)

  • Wang SJ, Fang TP, Rowley DD, Liu NW, Chen JO, Liu JF, Lin HL. Inspiratory muscle training facilitates liberation from mechanical ventilation in subacute critically ill patients-a randomized controlled trial. Front Med (Lausanne). 2025 Jan 29;11:1503678. doi: 10.3389/fmed.2024.1503678. eCollection 2024.

    PMID: 39944819DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Shu-Jane Wang, MS

    Zuoying Armed Forces General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 25, 2024

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

October 3, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

The data is available upon request from the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will become available 3 three years after the registration
Access Criteria
The data is available upon request from the principal investigator.

Locations

TW(1)