Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:24 PM
Study NCT ID:
NCT04207853
Status:
UNKNOWN
Last Update Posted:
2019-12-23
First Post:
2019-10-18
Brief Title:
Immediate Effect of Whole Body Vibration on Diabetics and Non-diabetics
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
Immediate Effect of Whole Body Vibration on Skin Temperature Circulation Peripheral Sensitivity and Plantar Pressure in Adults and Elderly With and Without Type 2 Diabetes Controlled Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DM
Brief 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
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
Detailed 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 46612 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 230 Whole body vibration is expected to show more significant improvements than sham and control groups in the outcomes studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None