- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207853
Immediate Effect of Whole Body Vibration on Diabetics and Non-diabetics (DM)
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
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Pernambuco
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Recife, Pernambuco, Brazil, 50740560
- Recruiting
- Universidade Federal de Pernambuco
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Contact:
- Kennedy F Alves, Especialista
- Phone Number: 081988895197
- Email: kennedyfpa@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: whole body vibration in diabetics (G1)
One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery
|
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.
|
Sham Comparator: the sham vibration group in diabetics (G2)
dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery
|
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.
|
No Intervention: diabetic control group (G3)
no treatment
|
|
Active Comparator: whole body vibration group in non-diabetics (G4)
One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery
|
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.
|
Sham Comparator: the vibration group " sham "in non-diabetics (G5)
dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery
|
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.
|
No Intervention: non-diabetic control group (G6)
no treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
skin temperature
Time Frame: " until study completion, an average of 2 months".
|
Infrared Thermography (TI)
|
" until study completion, an average of 2 months".
|
circulation
Time Frame: " until study completion, an average of 2 months".
|
Vascular Doppler ultrasound (UVD)
|
" until study completion, an average of 2 months".
|
peripheral sensitivity
Time Frame: " until study completion, an average of 2 months".
|
Esthesiometer
|
" until study completion, an average of 2 months".
|
plantar pressure
Time Frame: " until study completion, an average of 2 months".
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Baropodometry
|
" until study completion, an average of 2 months".
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Immediate, Vibration and DM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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