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

NCT03110406 | Unknown

• 1 other identifier: TUIRAMAIA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Renal Transplant Recipients

Keywords

renal transplant recipients; exercise; heart rate variability; Cardiovascular mortality

Outcome Measures

Primary Outcomes (1)

• heart rate variability

  Heart rate variability will be assessed through holter

  three months

Secondary Outcomes (1)

• Oxygen consumption

  three months

Study Arms (2)

whole-body vibration

EXPERIMENTAL

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

Simulated whole-body vibration

SHAM COMPARATOR

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

Interventions

whole-body vibration training OTHER

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.

Simulated whole-body vibration; whole-body vibration

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50740-050, Brazil

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• TUIRA O M

  UFPE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

TUIRA O MAIA

CONTACT

81997160176; tuiraomaia@gmail.com

Patrícia Erika M M

CONTACT

21268496; patmarinho@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Model Details: Intervention group and control group

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 12, 2017
• Study Start: March 10, 2017
• Primary Completion: September 30, 2017
• Study Completion: March 10, 2018
• Last Updated: April 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)