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Inspiratory Muscle Training and Hospital Complications (IMT)

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ClinicalTrials.gov Identifier: NCT02459444
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Mansueto Gomes Neto, Federal University of Bahia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Muscle Weakness Device: Powerbreathe Other: Physiotherapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Concurrent training




Primary Outcome Measures :
  1. hospital inpatient complications [ Time Frame: Discharge from hospital ]
    Follow-up during hospitalization


Secondary Outcome Measures :
  1. respiratory muscle strength [ Time Frame: After 4 weeks follow ]
    Measured with manometer for 3 reps.


Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459444


Locations
Brazil
Mansueto Gomes Neto
Salvador, Bahia, Brazil, 41950350
Sponsors and Collaborators
Federal University of Bahia
Investigators
Study Director: Balbino V Nepomuceno, MD Federal University of Bahia

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mansueto Gomes Neto, Physiotherapy course coordinator, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02459444     History of Changes
Other Study ID Numbers: U1111-1163-0679
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: March 20, 2017
Last Verified: March 2017

Keywords provided by Mansueto Gomes Neto, Federal University of Bahia:
Respiratory Muscles
Muscle Weakness
Hospitalization
Length of Stay
Mortality

Additional relevant MeSH terms:
Muscle Weakness
Paresis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathologic Processes
Signs and Symptoms