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Trial record 2 of 7879 for:    "Kidney Diseases"

Whole Body Vibration in Kidney Disease

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ClinicalTrials.gov Identifier: NCT02413073
Recruitment Status : Completed
First Posted : April 9, 2015
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Helen Fisio, Universidade Federal de Pernambuco

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.

Condition or disease Intervention/treatment Phase
Kidney Disease Procedure: Whole Body Vibration Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Sham Comparator: Sham of Whole Body Vibration
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.
Procedure: Whole Body Vibration
We wil use vibration in patients with kidney disease

Experimental: Whole body vibration Group
This group will be a training na vibratory platform with 12 weeks (3 months), held twice a week on alternate days
Procedure: Whole Body Vibration
We wil use vibration in patients with kidney disease




Primary Outcome Measures :
  1. muscle strength, as measured by isokinetic dynamometer (Kgf) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. postural equilibrium, as measured by biodex balance (score) [ Time Frame: 3 months ]
  2. functional capacity, as measured by 6MWT [ Time Frame: 3 months ]
  3. quality of life, as measured by questionnaire [ Time Frame: 3 months ]
  4. Thickness of Quadriceps Muscle, as measured by ultrasound [ Time Frame: 3 mounths ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02413073


Sponsors and Collaborators
Universidade Federal de Pernambuco
Investigators
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Principal Investigator: Helen KB Fuzari, MD Universidade Federal de Pernambuco

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Responsible Party: Helen Fisio, Principal Investigator, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier: NCT02413073     History of Changes
Other Study ID Numbers: 35872014.8.00005208
First Posted: April 9, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by Helen Fisio, Universidade Federal de Pernambuco:
whole body vibration
kidney disease

Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases