MedDataX Logo

Whole Body Vibration in Kidney Disease

NCT ID: NCT02413073

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

whole body vibration kidney disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type SHAM_COMPARATOR

Whole Body Vibration

Intervention Type PROCEDURE

We wil use vibration in patients with kidney disease

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

Group Type EXPERIMENTAL

Whole Body Vibration

Intervention Type PROCEDURE

We wil use vibration in patients with kidney disease

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whole Body Vibration

We wil use vibration in patients with kidney disease

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Helen Fisio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Helen KB Fuzari, MD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Pernambuco

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

35872014.8.00005208

Identifier Type: -

Identifier Source: org_study_id