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Inspiratory Muscle Training in Patients With End-stage Renal Disease

Primary Purpose

Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
POWERbreathe® Classic Light
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiopulmonary Physiotherapy Laboratory of UFPE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory Muscle Training Group

Sham Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Respiratory muscle strength
Evaluate by manometer
Diaphragm thickness
Evaluate by ultrasound

Secondary Outcome Measures

Chest wall volume
Evaluate by opto-electronic plethysmography
Pulmonary function
Evaluate by Spirometry
Walking distance
Evaluate by six-minute walk test
Quality of life
Evaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF
Diaphragm mobility
Evaluate by ultrasound

Full Information

First Posted
November 4, 2015
Last Updated
January 10, 2017
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT02599987
Brief Title
Inspiratory Muscle Training in Patients With End-stage Renal Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
POWERbreathe® Classic Light
Intervention Description
Inspiratory Muscle Training
Primary Outcome Measure Information:
Title
Respiratory muscle strength
Description
Evaluate by manometer
Time Frame
2 months
Title
Diaphragm thickness
Description
Evaluate by ultrasound
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Chest wall volume
Description
Evaluate by opto-electronic plethysmography
Time Frame
2 months
Title
Pulmonary function
Description
Evaluate by Spirometry
Time Frame
2 months
Title
Walking distance
Description
Evaluate by six-minute walk test
Time Frame
2 months
Title
Quality of life
Description
Evaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF
Time Frame
2 months
Title
Diaphragm mobility
Description
Evaluate by ultrasound
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cardiopulmonary Physiotherapy Laboratory of UFPE
City
Recife
State/Province
Pernambuco
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25972965
Citation
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Results Reference
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PubMed Identifier
23199095
Citation
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Results Reference
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PubMed Identifier
25372003
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. doi: 10.1590/bjpt-rbf.2014.0044. Epub 2014 Sep 12.
Results Reference
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PubMed Identifier
22257505
Citation
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.
Results Reference
background
PubMed Identifier
16506871
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.
Results Reference
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PubMed Identifier
14533277
Citation
Aliverti A, Pedotti A. Opto-electronic plethysmography. Monaldi Arch Chest Dis. 2003 Jan-Mar;59(1):12-6.
Results Reference
background
PubMed Identifier
12091180
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. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
Results Reference
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PubMed Identifier
15785838
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. doi: 10.1590/s0100-879x2005000200015. Epub 2005 Feb 15.
Results Reference
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PubMed Identifier
30052475
Citation
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.
Results Reference
derived

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Inspiratory Muscle Training in Patients With End-stage Renal Disease

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