NCT02459444

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

May 19, 2015

Last Update Submit

March 17, 2017

Conditions

Muscle Weakness

Keywords

Respiratory MusclesMuscle WeaknessHospitalizationLength of StayMortality

Outcome Measures

Primary Outcomes (1)

  • hospital inpatient complications

    Follow-up during hospitalization

    Discharge from hospital

Secondary Outcomes (1)

  • respiratory muscle strength

    After 4 weeks follow

Other Outcomes (3)

  • peripheral strength

    four weeks

  • Functional Independence Measure questionnaire

    Discharge from hospital

  • Index of Barthel

    Discharge from hospital

Study Arms (2)

IMT group and physiotherapy

EXPERIMENTAL

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: PowerbreatheOther: Physiotherapy

Sham IMT group

PLACEBO COMPARATOR

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

Interventions

PowerbreatheDEVICE

Respiratory equipment for physiotherapy, offering to load muscles inspiratory

Also known as: MODEL: CLASSIC LIGHT RESISTANCE, ANVISA: CLASS I 81001390001, MANUFACTURER: HAB INTERNATIONAL LTD - UNITED KINGDOM
IMT group and physiotherapy
PhysiotherapyOTHER

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

Also known as: Concurrent training
IMT group and physiotherapySham IMT group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansueto Gomes Neto

Salvador, Estado de Bahia, 41950350, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 18283429BACKGROUND

  • 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.

    PMID: 17186299RESULT

  • 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.

    PMID: 3740252RESULT

  • 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.

    PMID: 21385346RESULT

  • 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.

    PMID: 29282152DERIVED

MeSH Terms

Conditions

Muscle Weakness

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Balbino V Nepomuceno, MD

    Federal University of Bahia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapy course coordinator

Study Record Dates

First Submitted

May 19, 2015

First Posted

June 2, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03

Locations

BR(1)