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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03443986
• Other study ID #: Resistance, Vibration and DM
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: April 8, 2020

Study information

• Verified date: February 2020
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 8, 2020
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	François Talles Medeiros Rodrigues	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral circulation	Vascular Doppler ultrasound (UVD)	12 weeks
Primary	Functional performance	Timed Up and Go Test (TUG)	12 weeks
Primary	Peripheral circulation	Infrared Thermography (TI)	12 weeks
Secondary	Static postural alignment	Optoeletrônico system SMART DX100	12 weeks
Secondary	Plantar pressure distribution	Baropodometry	12 weeks