Inspiratory Muscle Training and Hospital Complications

Muscle Weakness Clinical Trial

— IMT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459444
• Other study ID #: U1111-1163-0679
• Status: Completed
• Phase: N/A
• First received: May 19, 2015
• Last updated: March 17, 2017
• Start date: May 2015
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

Device:
• Powerbreathe
Respiratory equipment for physiotherapy, offering to load muscles inspiratory

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

Locations

Country	Name	City	State
Brazil	Mansueto Gomes Neto	Salvador	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Bahia

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schönhofer 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. Review. — View 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. — View 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. — View 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 C — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	peripheral strength	Medical Research Council score	four weeks
Other	Functional Independence Measure questionnaire	Identifies said functional capacity	Discharge from hospital
Other	Index of Barthel	Identifies said functional capacity	Discharge from hospital
Primary	hospital inpatient complications	Follow-up during hospitalization	Discharge from hospital
Secondary	respiratory muscle strength	Measured with manometer for 3 reps.	After 4 weeks follow