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

U

Universidade Federal de Pernambuco

Status

Unknown

Conditions

Renal Transplant Recipients

Treatments

Other: whole-body vibration training

Study type

Interventional

Funder types

Other

Identifiers

NCT03110406
TUIRAMAIA

Details and patient eligibility

About

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

Full 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

Enrollment

20 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

20 participants in 2 patient groups

whole-body vibration
Experimental group
Description:
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. °
Treatment:
Other: whole-body vibration training
Simulated whole-body vibration
Sham Comparator group
Description:
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
Treatment:
Other: whole-body vibration training

Trial contacts and locations

1

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Central trial contact

Patrícia Erika M M; TUIRA O MAIA

Data sourced from clinicaltrials.gov

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