Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes

NCT ID: NCT03443986

Last Updated: 2020-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2020-04-08

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Triple: a researcher shall be exclusively responsible for the evaluations and reevaluations not having knowledge of what intervention

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).

Study Groups

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Resistance training associated with vibration

The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes.

Group Type EXPERIMENTAL

Resistance training associated with vibration

Intervention Type OTHER

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 sham

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.

Group Type SHAM_COMPARATOR

Resistance training associated with vibration sham

Intervention Type OTHER

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.

Control group

Will not be submitted to any physical intervention. It continues in your daily life with only monitoring via phone callings. Guidelines about foot care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Resistance training associated with vibration

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.

Intervention Type OTHER

Resistance training associated with vibration sham

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Change in the drug program in during the research
* Performing other physical activity during the training
* Hypertensive Peaks during treatment
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Maria das Graças Rodrigues de Araújo

Professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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François Talles Medeiros Rodrigues

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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François Talles M Rodrigues, Msc

Role: primary

81998432083

Other Identifiers

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Resistance, Vibration and DM

Identifier Type: -

Identifier Source: org_study_id

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