Immediate Effect of Whole Body Vibration on Diabetics and Non-diabetics

Last updated: December 20, 2019
Sponsor: Universidade Federal de Pernambuco
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

N/A

Clinical Study ID

NCT04207853
Immediate, Vibration and DM
  • Ages 45-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Introduction: Diabetes Mellitus (DM) is an important health condition of the population and its prevalence continues to grow due to population aging, economic development and urbanization. The exercise is an important factor of prevention and control, thereby decreasing the risk of metabolic diseases, cardiovascular diseases and improving the functionality of the patient with diabetes.

Objective: Evaluate the response of resistance training associated with wholebody vibration on peripheral circulation and functional performance of elderly with type 2 diabetes. Methods: This is a clinical trial study, controlled, randomized and blinded, which will follow the guidelines established by the Consolidated Standards of Reporting Trials (CONSORT). Patients will be recruited in the light of the eligibility criteria and randomly divided into 3 groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham (G2) and control group-guidelines about foot care (GC), establishing 36 treatment sessions, three times a week for the G1 and G2.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(I) Diabetics classified clinically as type 2 diagnosed more than 2 years and less than 20years of diagnosis; (II) Patients of both sexes aged between 45 and 80 years; (III) Befunctionally independent; (IV) Possess cognitive ability to answer and perform theexercises evaluated by the Mini-Mental State Examination (MMSE); (V) Patients withoutsevere foot deformities requiring therapeutic footwear; (VI) Not having orthopedicdisabilities; (VII) No indications of deep vein thrombosis; (VIII) Not making use ofmobility aids (IX) Presenting BMI between 18.50 and 34.99kg / m2; (X) For the control groupparticipants must fulfill all of the above requirements except item I.

Exclusion

Exclusion Criteria:

(I) Type I diabetics; (II) Diabetics and non-diabetics who are performing physical activityor who have performed any type of physical activity less than 2 months; (III) Have lowerlimb amputation; (IV) Patients with vertigo or labyrinthitis; (V) Have blood pressuregreater than or equal to 150/100 mmHg or less than or equal to 60/40 mmHg.

(VI) Presence of rheumatic diseases; (VII) Chemical dependents; (VIII) Blood glucosegreater than 300mg/dL.

Study Design

Total Participants: 30
Study Start date:
August 08, 2019
Estimated Completion Date:
February 28, 2020

Study Description

Diabetes Mellitus (DM) is an important health condition of the population and its prevalence continues to grow due to population aging, economic development and urbanization. Exercise is an important factor of prevention and metabolic control, thus reducing the risk of cardiovascular disease and improving the functionality of the patient with diabetes. The vibrating platform is a new biophysical modality of exercise. The individual exercises on a plate that oscillates up and down movements at a specific frequency and amplitude, and the exercises are performed static and / or dynamic. The present study aims to evaluate the immediate effect of whole body vibration on skin temperature, circulation, peripheral sensitivity and plantar pressure in adults and older adults with and without type 2 diabetes. controlled, randomized and blind, which will follow the guidelines set forth in the Consolidated Standards of Reporting Trials (CONSORT). It will be held at the Laboratory of Kinesiotherapy and Manual Therapeutic Resources (LACIRTEM) of the Department of Physical Therapy of the Federal University of Pernambuco (UFPE), in 2019. Patients will be recruited meeting the eligibility criteria and randomly assigned to 6 groups: whole body vibration in diabetics (G1), the sham vibration group in diabetics (G2) and diabetic control group (G3), the whole body vibration group in non-diabetics (G4), the vibration group " sham "in non-diabetics (G5) and non-diabetic control group (G6), establishing a single treatment session for G1, G2, G4 and G5. The control group of diabetics and non-diabetics will be evaluated, will receive pamphlets and guidelines on diabetes, will answer the research questionnaires and will be reassessed. This study will be submitted to the UFPE Human Research Ethics Committee and collection will only begin after its approval. All individuals must have read and signed the Informed Consent Form, authorizing their participation. The study is in line with National Health Council Resolution 466/12 and the Declaration of Helsinki. For statistical analysis of the results will be assigned a significance level of 95%, performed using the statistical software SPSS version 23.0. Whole body vibration is expected to show more significant improvements than sham and control groups in the outcomes studied.

Connect with a study center

  • Universidade Federal de Pernambuco

    Recife, Pernambuco 50740560
    Brazil

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.