Diabetes Mellitus, Type 2DMNCT04207853
Immediate Effect of Whole Body Vibration on Diabetics and Non-diabetics
A study testing whole body vibration em DM and whole body vibration em NDM in people with Diabetes Mellitus, Type 2, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- whole body vibration em DM and whole body vibration em NDM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Aug 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Presence of rheumatic diseases; (VII) Chemical dependents; (VIII) Blood glucose greater than 300mg/dL.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Pernambuco
Recife, Pernambuco, 50740560
Kennedy F Alves, Especialista, 081988895197, kennedyfpa@hotmail.com
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- whole body vibration em DM, Vibration "sham" em DM, whole body vibration em NDM, Vibration "sham" em NDM
- Keywords
- Diabetes Mellitus, Skin Temperature, Circulation, Peripheral Sensitivity, Plantar Pressure, Vibration
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration em DMOther
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.
Vibration "sham" em DMOther
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.
whole body vibration em NDMOther
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.
Vibration "sham" em NDMOther
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.
| Study group | Role | What they receive |
|---|---|---|
| whole body vibration in diabetics (G1) | Experimental | One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery Receives: Other: whole body vibration em DM |
| the sham vibration group in diabetics (G2) | Sham comparator | dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery Receives: Other: Vibration "sham" em DM |
| diabetic control group (G3) | No intervention | no treatment |
| whole body vibration group in non-diabetics (G4) | Active comparator | One 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery Receives: Other: whole body vibration em NDM |
| the vibration group " sham "in non-diabetics (G5) | Sham comparator | dummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery Receives: Other: Vibration "sham" em NDM |
| non-diabetic control group (G6) | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
skin temperature
Infrared Thermography (TI)
Measured: " until study completion, an average of 2 months".
circulation
Vascular Doppler ultrasound (UVD)
Measured: " until study completion, an average of 2 months".
peripheral sensitivity
Esthesiometer
Measured: " until study completion, an average of 2 months".
plantar pressure
Baropodometry
Measured: " until study completion, an average of 2 months".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start8 Aug 2019
- Primary completion20 Feb 2020 (estimated)
- Study completion28 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria das Graças Rodrigues de Araújo, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207853
- Sponsor's protocol ID
- Immediate, Vibration and DM
- Acronym
- DM
- Status last verified
- Dec 2019
- First submitted
- 18 Oct 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04207853
- Acronym / sponsor ID
- DM / Immediate, Vibration and DM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Skin Temperature, Circulation, Peripheral Sensitivity, Plantar Pressure, Vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 20 Feb 2020 (estimated)
- Study completion
- 28 Feb 2020 (estimated)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| whole body vibration in diabetics (G1) | Experimental | Other: whole body vibration em DMOne 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery |
| the sham vibration group in diabetics (G2) | Sham comparator | Other: Vibration "sham" em DMdummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery |
| diabetic control group (G3) | No intervention | –no treatment |
| whole body vibration group in non-diabetics (G4) | Active comparator | Other: whole body vibration em NDMOne 24Hz session, 4mm amplitude, 8 rep series, 45s intervention time, 30s recovery |
| the vibration group " sham "in non-diabetics (G5) | Sham comparator | Other: Vibration "sham" em NDMdummy vibration (sound stimulus), 8-rep series, 45s intervention time, 30s recovery |
| non-diabetic control group (G6) | No intervention | –no treatment |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
- Presence of rheumatic diseases; (VII) Chemical dependents; (VIII) Blood glucose greater than 300mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibration em DMThe 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. | Other | whole body vibration in diabetics (G1) |
| Vibration "sham" em DMSham 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. | Other | the sham vibration group in diabetics (G2) |
| whole body vibration em NDMThe 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. | Other | whole body vibration group in non-diabetics (G4) |
| Vibration "sham" em NDMSham 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. | Other | the vibration group " sham "in non-diabetics (G5) |
Primary outcome
skin temperature
Time frame: " until study completion, an average of 2 months".
Infrared Thermography (TI)
circulation
Time frame: " until study completion, an average of 2 months".
Vascular Doppler ultrasound (UVD)
peripheral sensitivity
Time frame: " until study completion, an average of 2 months".
Esthesiometer
plantar pressure
Time frame: " until study completion, an average of 2 months".
Baropodometry
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration em DM and whole body vibration em NDM in people with Diabetes Mellitus, Type 2, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
skin temperature (time frame: " until study completion, an average of 2 months".). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.