Inspiratory Muscle Training in Patients With End-stage Renal Disease

NCT ID: NCT02599987

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-12-31

Brief 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.

Conditions

Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inspiratory Muscle Training Group

Will use the breathing coach POWERbreathe® Classic Light. Participants will hold the workout three sets of 30 inspirations, 2 sessions per day, 7 days per week for 8 weeks. The training group will carry with IMT load of 50% of MIP. Weekly, patients attend the Cardiopulmonary Physical Therapy Laboratory for evaluation of MIP and load adjustment, performing a training session in the presence of the therapist, while other sessions will be held by the participant at home and registered in the diary training. The training took place with the patient sitting in chair with a back, with knees and hips flexed to 90 °, the participant will use a nose clip and the device coupled to the nozzle mouth, will be instructed to diaphragmatic breathing pattern.

Group Type: EXPERIMENTAL

POWERbreathe® Classic Light

Intervention Type: DEVICE

Inspiratory Muscle Training

Sham Group

Will use the breathing coach POWERbreathe® Classic Light. Participants will hold the workout three sets of 30 inspirations, 2 sessions per day, 7 days per week for 8 weeks. The sham group will carry without load, but will be subjected to the same procedures in the experimental group (simulation of load adjustment in the Cardiopulmonary Physical Therapy Laboratory) to ensure blinding of the study, other sessions will be held by the participant at home and registered in the diary training. The training took place with the patient sitting in chair with a back, with knees and hips flexed to 90 °, the participant will use a nose clip and the device coupled to the nozzle mouth, will be instructed to diaphragmatic breathing pattern.

Group Type: SHAM_COMPARATOR

POWERbreathe® Classic Light

Intervention Type: DEVICE

Inspiratory Muscle Training

Interventions

POWERbreathe® Classic Light

Inspiratory Muscle Training

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

ANA IRENE CARLOS DE MEDEIROS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiopulmonary Physiotherapy Laboratory of UFPE

Recife, Pernambuco, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 25972965 (View on PubMed)

Pellizzaro CO, Thome 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. Epub 2012 Nov 30.

Reference Type: BACKGROUND

PMID: 23199095 (View on PubMed)

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. doi: 10.1590/bjpt-rbf.2014.0044. Epub 2014 Sep 12.

Reference Type: BACKGROUND

PMID: 25372003 (View on PubMed)

Figueiredo RR, Castro AA, Napoleone FM, Faray L, de Paula Junior AR, Osorio RA. Respiratory biofeedback accuracy in chronic renal failure patients: a method comparison. Clin Rehabil. 2012 Aug;26(8):724-32. doi: 10.1177/0269215511431088. Epub 2012 Jan 18.

Reference Type: BACKGROUND

PMID: 22257505 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16506871 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 14533277 (View on PubMed)

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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

Reference Type: BACKGROUND

PMID: 12091180 (View on PubMed)

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. doi: 10.1590/s0100-879x2005000200015. Epub 2005 Feb 15.

Reference Type: BACKGROUND

PMID: 15785838 (View on PubMed)

Medeiros AIC, Brandao DC, Souza RJP, Fuzari HKB, Barros CESR, Barbosa JBN, Leite JC, Cavalcanti FCB, Dornelas de Andrade A, de Melo Marinho PE. Effects of daily inspiratory muscle training on respiratory muscle strength and chest wall regional volumes in haemodialysis patients: a randomised clinical trial. Disabil Rehabil. 2019 Dec;41(26):3173-3180. doi: 10.1080/09638288.2018.1485181. Epub 2018 Jul 27.

Reference Type: DERIVED

PMID: 30052475 (View on PubMed)

Other Identifiers

48538315.4.0000.5208

Identifier Type: -

Identifier Source: org_study_id