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

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

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

Study Overview

• Status: Unknown
• Conditions: Renal Transplant Recipients
• Intervention / Treatment: Other: whole-body vibration training

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50740-050
      • Recruiting
      • Universidade Federal de Pernambuco
      • Contact: Tuíra O Maia; Phone Number: 81997160176

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole-body vibration; 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; 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.
Sham Comparator: Simulated whole-body vibration; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal de Pernambuco
• Investigators: Principal Investigator: TUIRA O M, UFPE

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Anticipated): September 30, 2017
• Study Completion (Anticipated): March 10, 2018

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 11, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: exercise; heart rate variability; renal transplant recipients; Cardiovascular mortality
• Other Study ID Numbers: TUIRAMAIA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No