Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation

Study Overview
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Brief Summary
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Introduction: Renal transplantation represents the therapeutic mode with more durable treatment, greater cost-effectiveness, survival benefits and quality of life of the patients, however, with high cardiovascular mortality. Objectives: To evaluate the acute and chronic effects on heart rate variability and the impact of chronic kidney disease on cardiorespiratory fitness in renal transplant recipients following a full-body Vibration training program. Methods: It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the following inclusion criteria: age between 18 and 59 years, who underwent transplantation at least one year before and present a stable transplant function through the level Of creatinine

Detailed Description
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It will be a blinded randomized clinical trial (patient, evaluator and statistician), controlled and endowed with secrecy of allocation, to be performed in the Cardiopulmonary Physiotherapy Laboratory of the Physiotherapy Department of the Federal University of Pernambuco. Renal transplant recipients will be recruited at the Nephrology outpatient clinic of the Hospital das Clínicas de Pernambuco, according to the inclusion criteria

Official Title
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Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation: a Randomized Controlled Trial

Conditions
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Renal Transplant Recipients

Intervention / Treatment
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* Other: whole-body vibration training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 59 years who underwent transplantation at least one year before present a stable transplantation function through the creatinine level <1.8 mg / dL No drug use with ability to modify the autonomic nervous system, such as sympatholytic drugs Exclusion Criteria: unstable hypertension; Amyloidosis; Congestive heart failure, recent myocardial infarction, unstable angina; Musculoskeletal abnormality that impairs the performance of the exercises; Have a metal implant or cardiac pacemaker.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 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
Interventional Model Description: Intervention group and control group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: whole-body vibration<br>The whole-body vibration training will be performed with the patients in the static position, feet apart at 20 cm, semi-squat with knees at 15º flexion and upper limbs slightly flexed and supported on the platform. The exercises will be performed, in the first two weeks, for 10 minutes consisting of 60 seconds of low intensity with 30 seconds of rest standing in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. ° | Other: whole-body vibration training<br>* Training on the Vibrating platform will be performed with the patients in the static position.The exercises will be performed in the first two weeks for 10 minutes consisting of 60 seconds of low intensity and 30 seconds of standing rest in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. Monitoring of blood pressure, heart rate and peripheral oxygen saturation should be done every 5 minutes.<br>|
| Sham Comparator: Simulated whole-body vibration<br>The simulated whole-body vibration training will be performed with the patients in the static position, feet apart at 20 cm, in semi-squat with knees at 15º of flexion and upper limbs slightly flexed and supported on the platform that presents a motor that simulates the noise of the platform But does not produce any therapeutic effect | Other: whole-body vibration training<br>* Training on the Vibrating platform will be performed with the patients in the static position.The exercises will be performed in the first two weeks for 10 minutes consisting of 60 seconds of low intensity and 30 seconds of standing rest in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. Monitoring of blood pressure, heart rate and peripheral oxygen saturation should be done every 5 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability | Heart rate variability will be assessed through holter | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen consumption | Oxygen consumption will be assessed through exercise test | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal transplant recipients, exercise, heart rate variability, Cardiovascular mortality