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Completed

NCT Number: NCT02459444

Inspiratory Muscle Training and Hospital Complications

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansueto Gomes Neto

Salvador, Estado de Bahia, 41950350, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Powerbreathe

Device

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

Physiotherapy

Other

This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.

Other names: Concurrent training

Primary outcomes

  1. hospital inpatient complications

    Time frame: Discharge from hospital

    Follow-up during hospitalization

Secondary outcomes

  1. respiratory muscle strength

    Time frame: After 4 weeks follow

    Measured with manometer for 3 reps.

Other outcomes

  1. peripheral strength

    Time frame: four weeks

    Medical Research Council score

  2. Functional Independence Measure questionnaire

    Time frame: Discharge from hospital

    Identifies said functional capacity

  3. Index of Barthel

    Time frame: Discharge from hospital

    Identifies said functional capacity

Sponsors and collaborators

Lead sponsor

Federal University of Bahia

Other

Registry information

Official study title

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

Acronym: IMT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 2, 2015
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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