Immediate Effect of Whole Body Vibration on Diabetics and Non-diabetics
DM
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Aug 2019
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 8, 2019
CompletedFirst Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
December 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedDecember 23, 2019
December 1, 2019
7 months
October 18, 2019
December 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
skin temperature
Infrared Thermography (TI)
" until study completion, an average of 2 months".
circulation
Vascular Doppler ultrasound (UVD)
" until study completion, an average of 2 months".
peripheral sensitivity
Esthesiometer
" until study completion, an average of 2 months".
plantar pressure
Baropodometry
" until study completion, an average of 2 months".
Study Arms (6)
whole body vibration in diabetics (G1)
EXPERIMENTALOne 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery
the sham vibration group in diabetics (G2)
SHAM COMPARATORdummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery
diabetic control group (G3)
NO INTERVENTIONno treatment
whole body vibration group in non-diabetics (G4)
ACTIVE COMPARATOROne 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery
the vibration group " sham "in non-diabetics (G5)
SHAM COMPARATORdummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery
non-diabetic control group (G6)
NO INTERVENTIONno treatment
Interventions
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 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.
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 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.
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740560, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- 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).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doutor
Study Record Dates
First Submitted
October 18, 2019
First Posted
December 23, 2019
Study Start
August 8, 2019
Primary Completion
February 20, 2020
Study Completion
February 28, 2020
Last Updated
December 23, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share