Clinical trial NCT03443986: Effect of Resistance Training Associated With Whole-Body Vibration in Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus
Blood Flow Velocity
Skin Temperature
Postural Balance
Combined Modality Therapy
Vibration
Resistance Training
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peripheral circulation
timeFrame: 12 weeks
measure: Functional performance
timeFrame: 12 weeks
measure: Peripheral circulation
timeFrame: 12 weeks
Secondary outcomes:
measure: Static postural alignment
timeFrame: 12 weeks
measure: Plantar pressure distribution
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: François Talles Medeiros Rodrigues
state: Pernambuco
Study officials:
References: