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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
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Disease focused on measuring whole body vibration, kidney disease

Eligibility Criteria

40 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 29, 2014
    Last Updated
    November 13, 2016
    Sponsor
    Universidade Federal de Pernambuco
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    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

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    Whole Body Vibration in Kidney Disease

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