Whole Body Vibration in Kidney Disease
Primary Purpose
Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Whole Body Vibration
Sponsored by

About this trial
This is an interventional treatment trial for Kidney Disease focused on measuring whole body vibration, kidney disease
Eligibility Criteria
Inclusion criteria:
- Patients diagnosed with kidney disease, of both sexes, aged between 18 and 65 and on hemodialysis program for at least 3 months without the osteomusculoesquelético system changes that hamper the tests.
Exclusion criteria:
- Patients who heart failure, hypertension and uncontrolled arrhythmias, metal implants, pregnancy, thrombosis history, stroke sequelae.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Sham of Whole Body Vibration
Whole body vibration Group
Arm Description
This group will receive placebo treatment on the platform we'll use a little engine that will produce a very small vibration stimulus in the platform.
This group will be a training na vibratory platform with 12 weeks (3 months), held twice a week on alternate days
Outcomes
Primary Outcome Measures
muscle strength, as measured by isokinetic dynamometer (Kgf)
Secondary Outcome Measures
postural equilibrium, as measured by biodex balance (score)
functional capacity, as measured by 6MWT
quality of life, as measured by questionnaire
Thickness of Quadriceps Muscle, as measured by ultrasound
Full Information
NCT ID
NCT02413073
First Posted
November 29, 2014
Last Updated
November 13, 2016
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT02413073
Brief Title
Whole Body Vibration in Kidney Disease
Official Title
Effectiveness of Whole Body Vibration for Patients With Chronic Kidney Disease in the Interdialytic Period on Muscle Strength, Balance, Quality of Life and Functional Capacity: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
There are no studies in the literature evaluating the vibration of the whole body in patients with chronic renal failure. The study aims to assess the effectiveness of whole body vibration in patients with renal disease in the final phase in the interdialytic period. It will be a randomized, triple-blind, controlled and randomized. The pilot study will be 20 individuals initially. In intervention patients will be randomly divided into two groups: sham platform and platform. As a result it is expected that the training of whole body vibration may promote patient compliance, since it requires less physical effort for implementation and greater comfort in the application, thus allowing the sedentary and / or less active patients can benefit by to minimize the harmful effects of physical inactivity associated with pre-existing kidney problems.
Detailed Description
Studies of chronic kidney disease has conventional hemodialysis and physical therapy exercises as the most relevant interventions in the treatment and maintenance of the quality of life of these patients, but recent studies have shown significant results also in training with whole body vibration, especially for muscle strengthening, balance and quality of life of patients with different diseases. However, there are no studies in the literature analyzing whole-body vibration in patients with chronic renal failure.
Objective: To evaluate the effectiveness of wholy body vibration in patients with renal disease in the final stage in the interdialytic period.
Materials and Methods: A clinical trial randomized, triple-blind (patient, appraiser and statistics) controlled and supplied with random distribution. The study will be conducted in Cardiopulmonary Therapy Physical Therapy Laboratory of the Federal University of Pernambuco (UFPE). The sample is calculated from a pilot study to be carried out previously. The pilot study will be 20 subjects, 10 patients in each of the two groups.
In intervention patients will be randomly assigned to one of two groups: platform and platform sham. Training twice a week for 3 consecutive months. The evaluations will be conducted in two periods: before and after the intervention. The assessment tools are included: the isokinetic dynamometer to evaluate the maximal voluntary isometric contraction of the knee extensors, the Biodex Balance System to evaluate the static and dynamic body balance, the quality of life questionnaire specific for Chronic Renal patient - Kidney Disease Quality of Life - short Form (KDQOL-SFTM), and the 6-minute walk test to assess the functional capacity of the patient.
Expected results: It is expected that training in vibrating platform can promote patient compliance, since it requires less physical effort for implementation and greater comfort in the application, thus allowing the sedentary patients and / or less active can benefit , thus minimizing the harmful effects of physical inactivity associated with pre-existing kidney problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Disease
Keywords
whole body vibration, kidney disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham of Whole Body Vibration
Arm Type
Sham Comparator
Arm Description
This group will receive placebo treatment on the platform we'll use a little engine that will produce a very small vibration stimulus in the platform.
Arm Title
Whole body vibration Group
Arm Type
Experimental
Arm Description
This group will be a training na vibratory platform with 12 weeks (3 months), held twice a week on alternate days
Intervention Type
Procedure
Intervention Name(s)
Whole Body Vibration
Intervention Description
We wil use vibration in patients with kidney disease
Primary Outcome Measure Information:
Title
muscle strength, as measured by isokinetic dynamometer (Kgf)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
postural equilibrium, as measured by biodex balance (score)
Time Frame
3 months
Title
functional capacity, as measured by 6MWT
Time Frame
3 months
Title
quality of life, as measured by questionnaire
Time Frame
3 months
Title
Thickness of Quadriceps Muscle, as measured by ultrasound
Time Frame
3 mounths
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Patients diagnosed with kidney disease, of both sexes, aged between 18 and 65 and on hemodialysis program for at least 3 months without the osteomusculoesquelético system changes that hamper the tests.
Exclusion criteria:
Patients who heart failure, hypertension and uncontrolled arrhythmias, metal implants, pregnancy, thrombosis history, stroke sequelae.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen KB Fuzari, MD
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Whole Body Vibration in Kidney Disease
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