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

Renal Transplant Recipients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03110406
• Other study ID #: TUIRAMAIA
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2017
• Last updated: April 11, 2017
• Start date: March 10, 2017
• Est. completion date: March 10, 2018

Study information

• Verified date: March 2017
• Source: Universidade Federal de Pernambuco
• Contact: TUIRA O MAIA
• Phone: 81997160176
• Email: tuiraomaia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 10, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Renal Transplant Recipients

Intervention

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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	heart rate variability	Heart rate variability will be assessed through holter	three months
Secondary	Oxygen consumption	Oxygen consumption will be assessed through exercise test	three months