Whole Body Vibration in Kidney Disease

NCT02413073 | Completed Phase 4 DMC

• 1 other identifier: 35872014.8.00005208
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Kidney Disease

Keywords

whole body vibration; kidney disease

Outcome Measures

Primary Outcomes (1)

• muscle strength, as measured by isokinetic dynamometer (Kgf)

  3 months

Secondary Outcomes (4)

• postural equilibrium, as measured by biodex balance (score)

  3 months

• functional capacity, as measured by 6MWT

  3 months

• quality of life, as measured by questionnaire

  3 months

• Thickness of Quadriceps Muscle, as measured by ultrasound

  3 mounths

Study Arms (2)

Sham of Whole Body Vibration

SHAM COMPARATOR

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

Whole body vibration Group

EXPERIMENTAL

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

Interventions

Whole Body Vibration PROCEDURE

We wil use vibration in patients with kidney disease

Sham of Whole Body Vibration; Whole body vibration Group

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who heart failure, hypertension and uncontrolled arrhythmias, metal implants, pregnancy, thrombosis history, stroke sequelae.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Helen KB Fuzari, MD

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2014
• First Posted: April 9, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11