Clinical trial NCT02413073: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Disease
Keywords: whole body vibration
kidney disease
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: muscle strength, as measured by isokinetic dynamometer (Kgf)
timeFrame: 3 months
Secondary outcomes:
measure: postural equilibrium, as measured by biodex balance (score)
timeFrame: 3 months
measure: functional capacity, as measured by 6MWT
timeFrame: 3 months
measure: quality of life, as measured by questionnaire
timeFrame: 3 months
measure: Thickness of Quadriceps Muscle, as measured by ultrasound
timeFrame: 3 mounths
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Helen KB Fuzari, MD
role: PRINCIPAL_INVESTIGATOR
References: