Clinical trial NCT03110406: Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation
Official title: Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Transplant Recipients
Keywords: renal transplant recipients
exercise
heart rate variability
Cardiovascular mortality
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group and control group
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: heart rate variability
timeFrame: three months
Secondary outcomes:
measure: Oxygen consumption
timeFrame: three months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: UFPE
name: TUIRA O M
role: PRINCIPAL_INVESTIGATOR
References: