CompletedNot Applicable

Use of a New Isokinetic Device for Inspiratory Muscle Training

Brazil102 participantsStarted 2016-01

Plain-language summary

Introduction: It is well established that physical fitness improves muscle performance either in sedentary people or in athletes. In this regard, specific exercises for respiratory muscles can result in better functional performance in hospitalized individuals, especially in critically ill patients in prolonged weaning. Objectives: To compare the following variables between intervention and control patients: success in weaning, free time off ventilator on ICU after weaning, and gain of muscle strength with the use of the inspiratory muscle training (IMT). Patients and methods: Prospective randomized controlled clinical trial. Only individuals on prolonged weaning will be enrolled. They will undergo IMT or will be managed in a conventional manner. The primary endpoint will be successful weaning. In addition, other variables such as free time off ventilator on ICU after weaning and muscle strength will be measured. In addition, mortality in the ICU, inside the hospital and after discharge will be followed for one year after study entrance. Expected results: According to the working hypothesis, it is expected that the performance of patients undergoing IMT will be superior to the conventional treatment. Also, their time to mortality is expected to be longer.

Who can participate

Age range

18 Years – 86 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Individuals over the age of 18 on mechanical ventilation * Able to initiate ventilator weaning. Exclusion Criteria: * Positive serology for HIV * Other immunesupressive conditions * Life expectancy less than 12 months * Spinal cord injury above T8 * Mechanical ventilation started at another institution * Body mass index \>35 kg/m2.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Successful weaning

Timeframe: one year

Trial details

NCT IDNCT02932189

SponsorUniversidade Federal Fluminense

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-09

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