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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
whole body vibration em DM
Vibration "sham" em DM
whole body vibration em NDM
Vibration "sham" em NDM
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes Mellitus, Skin Temperature, Circulation, Peripheral Sensitivity, Plantar Pressure, Vibration

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

(I) Diabetics classified clinically as type 2 diagnosed more than 2 years and less than 20 years of diagnosis; (II) Patients of both sexes aged between 45 and 80 years; (III) Be functionally independent; (IV) Possess cognitive ability to answer and perform the exercises evaluated by the Mini-Mental State Examination (MMSE); (V) Patients without severe foot deformities requiring therapeutic footwear; (VI) Not having orthopedic disabilities; (VII) No indications of deep vein thrombosis; (VIII) Not making use of mobility aids (IX) Presenting BMI between 18.50 and 34.99kg / m2; (X) For the control group participants must fulfill all of the above requirements except item I.

Exclusion Criteria:

(I) Type I diabetics; (II) Diabetics and non-diabetics who are performing physical activity or who have performed any type of physical activity less than 2 months; (III) Have lower limb amputation; (IV) Patients with vertigo or labyrinthitis; (V) Have blood pressure greater 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 glucose greater than 300mg/dL.

Sites / Locations

  • Universidade Federal de PernambucoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Sham Comparator

No Intervention

Active Comparator

Sham Comparator

No Intervention

Arm Label

whole body vibration in diabetics (G1)

the sham vibration group in diabetics (G2)

diabetic control group (G3)

whole body vibration group in non-diabetics (G4)

the vibration group " sham "in non-diabetics (G5)

non-diabetic control group (G6)

Arm Description

One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery

dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery

no treatment

One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery

dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery

no treatment

Outcomes

Primary Outcome Measures

skin temperature
Infrared Thermography (TI)
circulation
Vascular Doppler ultrasound (UVD)
peripheral sensitivity
Esthesiometer
plantar pressure
Baropodometry

Secondary Outcome Measures

Full Information

First Posted
October 18, 2019
Last Updated
December 20, 2019
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT04207853
Brief Title
Immediate Effect of Whole Body Vibration on Diabetics and Non-diabetics
Acronym
DM
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Anticipated)
Study Completion Date
February 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Skin Temperature, Circulation, Peripheral Sensitivity, Plantar Pressure, Vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
group the patient will enter. The patient will be allocated among three groups. After the final evaluations, all data will be analyzed by another researcher directed solely to that purpose. Therefore, there will be a triple blinding (researcher, patient and statistician).
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
whole body vibration in diabetics (G1)
Arm Type
Experimental
Arm Description
One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery
Arm Title
the sham vibration group in diabetics (G2)
Arm Type
Sham Comparator
Arm Description
dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery
Arm Title
diabetic control group (G3)
Arm Type
No Intervention
Arm Description
no treatment
Arm Title
whole body vibration group in non-diabetics (G4)
Arm Type
Active Comparator
Arm Description
One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery
Arm Title
the vibration group " sham "in non-diabetics (G5)
Arm Type
Sham Comparator
Arm Description
dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery
Arm Title
non-diabetic control group (G6)
Arm Type
No Intervention
Arm Description
no treatment
Intervention Type
Other
Intervention Name(s)
whole body vibration em DM
Intervention Description
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. Vibration is supposed to activate muscle spindles and evoke contractions, which are induced by the complex spinal and supraspinal neurophysiological mechanism known as the tonic vibration reflex.
Intervention Type
Other
Intervention Name(s)
Vibration "sham" em DM
Intervention Description
Sham vibration will be performed with the platform disconnected. A sound device will be connected producing a noise similar to the connected platform for a time equivalent to the treatment protocol, as it will not be possible to visibly distinguish the vibratory stimulus. Participants who will undergo false vibration will not have contact with those who will perform the protocol effectively.
Intervention Type
Other
Intervention Name(s)
whole body vibration em NDM
Intervention Description
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. Vibration is supposed to activate muscle spindles and evoke contractions, which are induced by the complex spinal and supraspinal neurophysiological mechanism known as the tonic vibration reflex.
Intervention Type
Other
Intervention Name(s)
Vibration "sham" em NDM
Intervention Description
Sham vibration will be performed with the platform disconnected. A sound device will be connected producing a noise similar to the connected platform for a time equivalent to the treatment protocol, as it will not be possible to visibly distinguish the vibratory stimulus. Participants who will undergo false vibration will not have contact with those who will perform the protocol effectively.
Primary Outcome Measure Information:
Title
skin temperature
Description
Infrared Thermography (TI)
Time Frame
" until study completion, an average of 2 months".
Title
circulation
Description
Vascular Doppler ultrasound (UVD)
Time Frame
" until study completion, an average of 2 months".
Title
peripheral sensitivity
Description
Esthesiometer
Time Frame
" until study completion, an average of 2 months".
Title
plantar pressure
Description
Baropodometry
Time Frame
" until study completion, an average of 2 months".

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (I) Diabetics classified clinically as type 2 diagnosed more than 2 years and less than 20 years of diagnosis; (II) Patients of both sexes aged between 45 and 80 years; (III) Be functionally independent; (IV) Possess cognitive ability to answer and perform the exercises evaluated by the Mini-Mental State Examination (MMSE); (V) Patients without severe foot deformities requiring therapeutic footwear; (VI) Not having orthopedic disabilities; (VII) No indications of deep vein thrombosis; (VIII) Not making use of mobility aids (IX) Presenting BMI between 18.50 and 34.99kg / m2; (X) For the control group participants must fulfill all of the above requirements except item I. Exclusion Criteria: (I) Type I diabetics; (II) Diabetics and non-diabetics who are performing physical activity or who have performed any type of physical activity less than 2 months; (III) Have lower limb amputation; (IV) Patients with vertigo or labyrinthitis; (V) Have blood pressure greater 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 glucose greater than 300mg/dL.
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740560
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kennedy F Alves, Especialista
Phone
081988895197
Email
kennedyfpa@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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