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Inspiratory Muscle Training and Hospital Complications (IMT)

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Powerbreathe
Physiotherapy
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Respiratory Muscles, Muscle Weakness, Hospitalization, Length of Stay, Mortality

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mansueto Gomes Neto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IMT group and physiotherapy

Sham IMT group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

hospital inpatient complications
Follow-up during hospitalization

Secondary Outcome Measures

respiratory muscle strength
Measured with manometer for 3 reps.

Full Information

First Posted
May 19, 2015
Last Updated
March 17, 2017
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT02459444
Brief Title
Inspiratory Muscle Training and Hospital Complications
Acronym
IMT
Official Title
Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Weakness
Keywords
Respiratory Muscles, Muscle Weakness, Hospitalization, Length of Stay, Mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT group and physiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham IMT group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Powerbreathe
Other Intervention Name(s)
MODEL: CLASSIC LIGHT RESISTANCE, ANVISA: CLASS I 81001390001, MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM
Intervention Description
Respiratory equipment for physiotherapy, offering to load muscles inspiratory
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Other Intervention Name(s)
Concurrent training
Intervention Description
This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
Primary Outcome Measure Information:
Title
hospital inpatient complications
Description
Follow-up during hospitalization
Time Frame
Discharge from hospital
Secondary Outcome Measure Information:
Title
respiratory muscle strength
Description
Measured with manometer for 3 reps.
Time Frame
After 4 weeks follow
Other Pre-specified Outcome Measures:
Title
peripheral strength
Description
Medical Research Council score
Time Frame
four weeks
Title
Functional Independence Measure questionnaire
Description
Identifies said functional capacity
Time Frame
Discharge from hospital
Title
Index of Barthel
Description
Identifies said functional capacity
Time Frame
Discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Balbino V Nepomuceno, MD
Organizational Affiliation
Federal University of Bahia
Official's Role
Study Director
Facility Information:
Facility Name
Mansueto Gomes Neto
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950350
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
18283429
Citation
Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.
Results Reference
background
PubMed Identifier
17186299
Citation
Griffiths LA, McConnell AK. The influence of inspiratory and expiratory muscle training upon rowing performance. Eur J Appl Physiol. 2007 Mar;99(5):457-66. doi: 10.1007/s00421-006-0367-6. Epub 2006 Dec 22.
Results Reference
result
PubMed Identifier
3740252
Citation
Hogan MC, Welch HG. Effect of altered arterial O2 tensions on muscle metabolism in dog skeletal muscle during fatiguing work. Am J Physiol. 1986 Aug;251(2 Pt 1):C216-22. doi: 10.1152/ajpcell.1986.251.2.C216.
Results Reference
result
PubMed Identifier
21385346
Citation
Martin AD, Smith BK, Davenport PD, Harman E, Gonzalez-Rothi RJ, Baz M, Layon AJ, Banner MJ, Caruso LJ, Deoghare H, Huang TT, Gabrielli A. Inspiratory muscle strength training improves weaning outcome in failure to wean patients: a randomized trial. Crit Care. 2011;15(2):R84. doi: 10.1186/cc10081. Epub 2011 Mar 7.
Results Reference
result
PubMed Identifier
29282152
Citation
Nepomuceno BRV Jr, Barreto MS, Almeida NC, Guerreiro CF, Xavier-Souza E, Neto MG. Safety and efficacy of inspiratory muscle training for preventing adverse outcomes in patients at risk of prolonged hospitalisation. Trials. 2017 Dec 28;18(1):626. doi: 10.1186/s13063-017-2372-y.
Results Reference
derived

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Inspiratory Muscle Training and Hospital Complications

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