Inspiratory Muscle Training and Hospital Complications (IMT)

March 17, 2017 updated by: Mansueto Gomes Neto, Federal University of Bahia

Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization

The inspiratory muscle training (IMT) is a feasible and safe strategy for patients and athletes, your goal is to recondition the respiratory muscles, providing optimization of lung capacity, either for high performance sport as to support metabolic wear caused by illness. It is generally agreed the positive impact of the application of a TMI Protocol on maximal inspiratory pressure (MIP), this benefit encourages individuals sick since weaning from mechanical ventilation (MV), to the optimization of physical performance in cardiac and / or pulmonary rehabilitation. The TMI is based on the principles: the burden imposed on the muscle; the specificity of training; the reversibility of the gain and muscle atrophy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This prospective double-blind (patient and evaluator) randomised controlled trial compared the efficacy of inspiratory muscle training and inspiratory muscle training. The study protocol for this trial was described elsewhere. This study was conducted in accordance with Consolidated Standards of Reporting Trials recommendations. The trial was performed at the Roberto Santos General Hospital in Salvador, Bahia, Brazil. This study was approved by the institutional hospital ethics committee (approval reference number 03/2014). Before enrolment, written informed consent was obtained from participants or their legal guardians.

Study Type

Interventional

Enrollment (Actual)

54

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

  • Brazil
    • Bahia
      • Salvador, Bahia, Brazil, 41950350
        • Mansueto Gomes Neto

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to the hospital ward;
  • At least two of the following risk factors for prolonged hospitalization: two or more comorbidities; sepsis; liver, lung, or kidney diseases; neoplasia; mechanical ventilation; and use of vasopressor or dialysis therapy.

Exclusion Criteria:

  • Patients with a cognitive disability that made them unable to perform the respiratory training;
  • Uncontrolled cardiac arrhythmias;
  • Circulatory shock;
  • Acute ischemic heart disease;
  • acute respiratory failure (characterised by a partial pressure of arterial oxygen < 60 mmHg or a partial pressure of arterial carbon dioxide > 50 mmHg);
  • neuromuscular disease or myopathies;
  • diaphragmatic paresis or paralysis were excluded from the protocol.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT group and physiotherapy
Inspiratory muscle training with POWERBREATHE an approximate load of 50 % of MIP , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program.
Device: Powerbreathe
Respiratory equipment for physiotherapy, offering to load muscles inspiratory
Other Names:
  • MODEL: CLASSIC LIGHT RESISTANCE
  • ANVISA: CLASS I 81001390001
  • MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM
Other: Physiotherapy
This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
Other Names:
  • Concurrent training
Placebo Comparator: Sham IMT group
Inspiratory muscle training with the same device in the experimental group , however without charge , for 1 set of 30 breaths twice a day, 7 days a week for 4 weeks ( total 56 sessions). Associated with physiotherapy program.
Other: Physiotherapy
This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
Other Names:
  • Concurrent training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital inpatient complications
Time Frame: Discharge from hospital
Follow-up during hospitalization
Discharge from hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory muscle strength
Time Frame: After 4 weeks follow
Measured with manometer for 3 reps.
After 4 weeks follow

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
peripheral strength
Time Frame: four weeks
Medical Research Council score
four weeks
Functional Independence Measure questionnaire
Time Frame: Discharge from hospital
Identifies said functional capacity
Discharge from hospital
Index of Barthel
Time Frame: Discharge from hospital
Identifies said functional capacity
Discharge from hospital

Collaborators and Investigators

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

Sponsor

Federal University of Bahia

Investigators

  • Study Director: Balbino V Nepomuceno, MD, Federal University of Bahia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 19, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

June 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2017

Last Update Submitted That Met QC Criteria

March 17, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1163-0679

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.

Clinical Trials on Muscle Weakness

Clinical Trials on Powerbreathe

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe