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

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ClinicalTrials.gov Identifier: NCT03110406
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
TUIRA OLIVEIRA MAIA, Universidade Federal de Pernambuco

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


Condition or disease Intervention/treatment Phase
Renal Transplant Recipients Other: whole-body vibration training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group and control group
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation: a Randomized Controlled Trial
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : September 30, 2017
Estimated Study Completion Date : March 10, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. heart rate variability [ Time Frame: three months ]
    Heart rate variability will be assessed through holter


Secondary Outcome Measures :
  1. Oxygen consumption [ Time Frame: three months ]
    Oxygen consumption will be assessed through exercise test



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110406


Contacts
Contact: TUIRA O MAIA 81997160176 tuiraomaia@gmail.com
Contact: Patrícia Erika M M 21268496 patmarinho@yahoo.com

Locations
Brazil
Universidade Federal de Pernambuco Recruiting
Recife, Pernambuco, Brazil, 50740-050
Contact: Tuíra O Maia    81997160176      
Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
Principal Investigator: TUIRA O M UFPE

Responsible Party: TUIRA OLIVEIRA MAIA, Master, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT03110406     History of Changes
Other Study ID Numbers: TUIRAMAIA
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TUIRA OLIVEIRA MAIA, Universidade Federal de Pernambuco:
renal transplant recipients
exercise
heart rate variability
Cardiovascular mortality