Inspiratory Muscle Training in Patients With End-stage Renal Disease

Kidney Disease Clinical Trial

Official title:

Effectiveness of Inspiratory Muscle Training in Respiratory Muscle Strength, Chest Wall Volume, Diaphragm Thickness and Mobility in Patients With End-stage Renal Disease: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599987
• Other study ID #: 48538315.4.0000.5208
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: January 10, 2017
• Start date: November 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Background: Patients with chronic kidney disease on hemodialysis may have reduced diffusion capacity, lung function and gas exchange due to mechanical and hemodynamic changes in the respiratory system, and decreased respiratory muscle strength resulting from uremic myopathy. The inspiratory muscle training (IMT) appears as an instrument to improve the inspiratory muscle strength, with positive effects on functional capacity and quality of life of kidney patients, however, the effects of IMT were not addressed in the specific variables of the respiratory system and to date there are no studies on the use of daily training in this population. Objective: To evaluate the effectiveness of daily inspiratory muscle training on respiratory muscle strength, chest wall volume, diaphragm thickness and mobility of end-stage renal disease patients. Methods: A randomized controlled clinical trial to be developed in Cardiopulmonary Physical Therapy Laboratory of the Universidade Federal de Pernambuco (UFPE) during the period from November 2015 to December 2016. The sample is composed of 24 individuals aged 18 and 65, having CKD, to perform hemodialysis for at least twelve months and provide inspiratory muscle weakness. Patients will be divided into two groups, the training group will be IMT with POWER-breathe®, load of 50% of MIP, duration of three sets of 30 inspirations, frequency of two sessions per day, 7 days a week for 8 weeks, since the sham group will be subjected to the same procedure (duration and frequency), but without load. Participants will be assessed before and after intervention through a global assessment form, questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF, diaphragmatic ultrasound, opto-electronic plethysmography, spirometry, manometer and six-minute walk test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have a chronic kidney disease

• Hemodialysis for a minimum period of twelve months

• Inspiratory muscle weakness, with MIP <80cmH2O for men and <60cmH2O for women

Exclusion Criteria:

• Neurological deficit

• Chronic lung disease

• Severe heart disease (unstable angina and acute myocardial infarction)

• Decompensated diabetes

• Infectious disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• POWERbreathe® Classic Light
Inspiratory Muscle Training

Locations

Country	Name	City	State
Brazil	Cardiopulmonary Physiotherapy Laboratory of UFPE	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6. — View Citation

ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories.. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. — View Citation

Caruso P, Albuquerque AL, Santana PV, Cardenas LZ, Ferreira JG, Prina E, Trevizan PF, Pereira MC, Iamonti V, Pletsch R, Macchione MC, Carvalho CR. Diagnostic methods to assess inspiratory and expiratory muscle strength. J Bras Pneumol. 2015 Mar-Apr;41(2):110-23. doi: 10.1590/S1806-37132015000004474. — View Citation

Duarte PS, Ciconelli RM, Sesso R. Cultural adaptation and validation of the "Kidney Disease and Quality of Life--Short Form (KDQOL-SF 1.3)" in Brazil. Braz J Med Biol Res. 2005 Feb;38(2):261-70. — View Citation

Enright SJ, Unnithan VB, Heward C, Withnall L, Davies DH. Effect of high-intensity inspiratory muscle training on lung volumes, diaphragm thickness, and exercise capacity in subjects who are healthy. Phys Ther. 2006 Mar;86(3):345-54. — View Citation

Figueiredo RR, Castro AA, Napoleone FM, Faray L, de Paula Júnior AR, Osório RA. Respiratory biofeedback accuracy in chronic renal failure patients: a method comparison. Clin Rehabil. 2012 Aug;26(8):724-32. doi: 10.1177/0269215511431088. — View Citation

Pellizzaro CO, Thomé FS, Veronese FV. Effect of peripheral and respiratory muscle training on the functional capacity of hemodialysis patients. Ren Fail. 2013;35(2):189-97. doi: 10.3109/0886022X.2012.745727. — View Citation

Pessoa IM, Houri Neto M, Montemezzo D, Silva LA, Andrade AD, Parreira VF. Predictive equations for respiratory muscle strength according to international and Brazilian guidelines. Braz J Phys Ther. 2014 Sep-Oct;18(5):410-8. English, Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory muscle strength	Evaluate by manometer	2 months	Yes
Primary	Diaphragm thickness	Evaluate by ultrasound	2 months	Yes
Secondary	Chest wall volume	Evaluate by opto-electronic plethysmography	2 months	Yes
Secondary	Pulmonary function	Evaluate by Spirometry	2 months	Yes
Secondary	Walking distance	Evaluate by six-minute walk test	2 months	Yes
Secondary	Quality of life	Evaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF	2 months	Yes
Secondary	Diaphragm mobility	Evaluate by ultrasound	2 months	Yes