Clinical trial NCT02459444: Inspiratory Muscle Training and Hospital Complications
Official title: Safety and Efficacy of Inspiratory Muscle Training for Preventing Adverse Outcomes in Patients at Risk of Prolonged Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Weakness
Keywords: Respiratory Muscles
Muscle Weakness
Hospitalization
Length of Stay
Mortality
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: hospital inpatient complications
timeFrame: Discharge from hospital
Secondary outcomes:
measure: respiratory muscle strength
timeFrame: After 4 weeks follow
Other outcomes:
measure: peripheral strength
timeFrame: four weeks
measure: Functional Independence Measure questionnaire
timeFrame: Discharge from hospital
measure: Index of Barthel
timeFrame: Discharge from hospital
Locations:
city: Salvador
country: Brazil
facility: Mansueto Gomes Neto
state: Bahia
Study officials:
affiliation: Federal University of Bahia
name: Balbino V Nepomuceno, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.