Diabetes Mellitus, Type 2NCT03443986
Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes
A study testing Resistance training associated with vibration 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 60 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Resistance training associated with vibration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Feb 2018to 8 Apr 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present overweight or obese class I, with BMI between 25.00 and 34.99 kg/m2 (WHO, 2009)
- Be functionally independent
- Having cognitive ability to respond and perform the exercisesevaluated by Mini-Mental State examination (MMSE), prepared by Folstein et al. (1975) and translation/modification proposed by Lawrence and van Heerden (2006), using as a bridge to cut to illiterate individuals = 19 points (BRAZIL, 2006)
- Inactive (0 to 5 points) or less active (6 to 11 points) according to the Questionnaire of Habitual Physical Activity (QAFH)
- Patients without severe foot deformities requiring therapeutic shoes
- Do not have orthopedic deficiencies
- No indications of deep vein thrombosis
- Do not use locomotion auxiliary equipment
Who cannot join
- Change in the drug program in during the research
- Performing other physical activity during the training
- Hypertensive Peaks during treatment
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
François Talles Medeiros Rodrigues
Recife, Pernambuco, 51020240
François Talles M Rodrigues, Msc, 81998432083, francoismedeirosfisiot@gmail.com
About this study
Official title: Effect of Resistance Training Associated With Whole-Body Vibration Over the Peripheral Circulation and the Functional Performance of the Elderly With Type 2 Diabetes: Randomized 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 whole-body 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Resistance training associated with vibration, Resistance training associated with vibration sham
- Keywords
- Diabetes Mellitus, Blood Flow Velocity, Skin Temperature, Postural Balance, Combined Modality Therapy, Vibration, Resistance Training
- 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.
Resistance training associated with vibrationOther
The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration and 5 minutes of slowdown.
Resistance training associated with vibration shamOther
he workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration "sham" and 5 minutes of slowdown.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training associated with vibration | Experimental | The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes. Receives: Other: Resistance training associated with vibration |
| Resistance training associated with sham | Sham comparator | The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration "sham" and 5 minutes of slowdown. The vibration sham; will be held with the disconnected platform. A device will be connected producing a noise similar to the sound of the connected platform for a time equivalent to the treatment protocol, since it will not be possible to distinguishing noticeably stimulate vibrator. Participants that will undergo false vibration will not have contact with those who carry out the real treatment. Receives: Other: Resistance training associated with vibration sham |
| Control group | No intervention | Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral circulation
Vascular Doppler ultrasound (UVD)
Measured: 12 weeks
Functional performance
Timed Up and Go Test (TUG)
Measured: 12 weeks
Peripheral circulation
Infrared Thermography (TI)
Measured: 12 weeks
Secondary outcomes (2)
Static postural alignment
Optoeletrônico system SMART DX100
Measured: 12 weeks
Plantar pressure distribution
Baropodometry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start26 Feb 2018
- Primary completion8 Aug 2019
- Study completion8 Apr 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
- Three groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham; (G2) and control group-guidelines about foot care (GC)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 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
- NCT03443986
- Sponsor's protocol ID
- Resistance, Vibration and DM
- Status last verified
- Feb 2020
- First submitted
- 2 Feb 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training Associated With Whole-Body Vibration Over the Peripheral Circulation and the Functional Performance of the Elderly With Type 2 Diabetes: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03443986
- Acronym / sponsor ID
- Resistance, Vibration and DM
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Blood Flow Velocity, Skin Temperature, Postural Balance, Combined Modality Therapy, Vibration, Resistance Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 8 Aug 2019 (actual)
- Study completion
- 8 Apr 2020 (estimated)
- First posted
- 23 Feb 2018 (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 whole-body 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Three groups: resistance training associated with whole body vibration (G1), resistance training associated with vibration sham; (G2) and control group-guidelines about foot care (GC)
| Arm | Type | Receives |
|---|---|---|
| Resistance training associated with vibration | Experimental | Other: Resistance training associated with vibrationThe workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes. |
| Resistance training associated with sham | Sham comparator | Other: Resistance training associated with vibration shamThe workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration "sham" and 5 minutes of slowdown. The vibration sham; will be held with the disconnected platform. A device will be connected producing a noise similar to the sound of the connected platform for a time equivalent to the treatment protocol, since it will not be possible to distinguishing noticeably stimulate vibrator. Participants that will undergo false vibration will not have contact with those who carry out the real treatment. |
| Control group | No intervention | –Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Present overweight or obese class I, with BMI between 25.00 and 34.99 kg/m2 (WHO, 2009)
- Be functionally independent
- Having cognitive ability to respond and perform the exercisesevaluated by Mini-Mental State examination (MMSE), prepared by Folstein et al. (1975) and translation/modification proposed by Lawrence and van Heerden (2006), using as a bridge to cut to illiterate individuals = 19 points (BRAZIL, 2006)
- Inactive (0 to 5 points) or less active (6 to 11 points) according to the Questionnaire of Habitual Physical Activity (QAFH)
- Patients without severe foot deformities requiring therapeutic shoes
Key exclusion criteria (3 listed)
- Change in the drug program in during the research
- Performing other physical activity during the training
- Hypertensive Peaks during treatment
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 |
|---|---|---|
| Resistance training associated with vibrationThe workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration and 5 minutes of slowdown. | Other | Resistance training associated with vibration |
| Resistance training associated with vibration shamhe workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration "sham" and 5 minutes of slowdown. | Other | Resistance training associated with sham |
Primary outcome
Peripheral circulation
Time frame: 12 weeks
Vascular Doppler ultrasound (UVD)
Functional performance
Time frame: 12 weeks
Timed Up and Go Test (TUG)
Peripheral circulation
Time frame: 12 weeks
Infrared Thermography (TI)
2 secondary outcomes
Static postural alignment
Time frame: 12 weeks
Plantar pressure distribution
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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 Resistance training associated with vibration 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 8 inclusion and 3 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 13 Feb 2020. 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?
Peripheral circulation (time frame: 12 weeks). The study lists 3 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 13 Feb 2020.