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
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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).
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Change in the drug program in during the research
- •Performing other physical activity during the training
- •Hypertensive Peaks during treatment
研究组 & 干预措施
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.
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.
干预措施: Resistance training associated with vibration (Other)
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.
干预措施: Resistance training associated with vibration sham (Other)
结局指标
主要结局
Functional performance
时间窗: 12 weeks
Timed Up and Go Test (TUG)
Peripheral circulation
时间窗: 12 weeks
Vascular Doppler ultrasound (UVD)
次要结局
- Plantar pressure distribution(12 weeks)
- Static postural alignment(12 weeks)
研究者
Maria das Graças Rodrigues de Araújo
Professor, PhD
Universidade Federal de Pernambuco