Effect of Inspiratory Muscle Training on Ventilated Patients in an Intensive Care Unit

NCT ID: NCT06611683

Last Updated: 2024-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients on mechanical ventilation often experience rapid diaphragm atrophy on the second day, resulting in muscle fiber changes, respiratory muscle weakness. Clinical studies have explored enhancing diaphragm and respiratory muscle strength and endurance through inspiratory muscle, expiratory muscle, and combined respiratory muscle training. This study was to determine if inspiratory muscle training significantly facilitates liberation from mechanical ventilation and improves muscle strength when compared to without IMT among subacute critically ill adult patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critically Ill, Subacute Adult Patients Mechanically Ventilation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Inspiratory Muscle Training

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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type PROCEDURE

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.

Non-inspiratory muscle training

Subjects received routine care.

Group Type SHAM_COMPARATOR

Routine care

Intervention Type PROCEDURE

Subjects received routine care without intervention.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Inspiratory muscle training

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.

Intervention Type PROCEDURE

Routine care

Subjects received routine care without intervention.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* requiring invasive mechanical ventilation for 2 days in an ICU

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zuoying Armed Forces General Hospital

UNKNOWN

Sponsor Role collaborator

Kaohsiung Chang Gung Memorial Hospital,Taiwan

UNKNOWN

Sponsor Role collaborator

Chang Gung University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hui-Ling Lin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Shu-Jane Wang, MS

Role: STUDY_DIRECTOR

Zuoying Armed Forces General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zuoying Armed Forces General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39944819 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KAFGHIRB107-027

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.