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

Sponsor

Universidade Federal de Pernambuco (Other)

Overall Status

Unknown status

CT.gov ID

NCT03443986

Collaborator

(none)

Enrollment

Location

Arms

25.4

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Other: Resistance training associated with vibration Other: Resistance training associated with vibration sham	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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)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 (Participant, Care Provider, Investigator)

Masking Description:

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).

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 26, 2018

Actual Primary Completion Date :

Aug 8, 2019

Anticipated Study Completion Date :

Apr 8, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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.
Sham Comparator: 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.	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.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Other: Resistance training associated with vibration

Sham Comparator: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Peripheral circulation [12 weeks]
Vascular Doppler ultrasound (UVD)
Functional performance [12 weeks]
Timed Up and Go Test (TUG)
Peripheral circulation [12 weeks]
Infrared Thermography (TI)

Secondary Outcome Measures

Static postural alignment [12 weeks]
Optoeletrônico system SMART DX100
Plantar pressure distribution [12 weeks]
Baropodometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Present overweight or obese class I, with BMI between 25.00 and 34.99 kg/m2 (WHO,

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