Inspiratory Muscle Training in Patients With End-stage Renal Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Kidney Disease

Intervention / Treatment
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* Device: POWERbreathe® Classic Light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inspiratory Muscle Training Group<br>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. | Device: POWERbreathe® Classic Light<br>* Inspiratory Muscle Training<br>|
| Sham Comparator: Sham Group<br>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. | Device: POWERbreathe® Classic Light<br>* Inspiratory Muscle Training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | Evaluate by manometer | 2 months | 
| Diaphragm thickness | Evaluate by ultrasound | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chest wall volume | Evaluate by opto-electronic plethysmography | 2 months | 
| Pulmonary function | Evaluate by Spirometry | 2 months | 
| Walking distance | Evaluate by six-minute walk test | 2 months | 
| Quality of life | Evaluate by questionnaire Kidney Disease Quality of Life Instrument Short Form - KDQOL-SF | 2 months | 
| Diaphragm mobility | Evaluate by ultrasound | 2 months |