Intervention Project for Diabetic Foot Prevention Through the Development of a Vibratory Therapy Program at the National Rehabilitation Institute LGII
试验速览
- 阶段
- 3 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Effect of whole body vibration on TcPO2 levels
研究概览
简要总结
In order to determine the effect of whole body vibration on TcPO2 levels in patients with type 2 diabetes, 40 subjects will undertake whole body vibration exercise three times a week for 12 weeks. TcPO2 will be measured before and after the intervention. A second control group with type 2 diabetes will also have TcPO2 levels measured before and after the 12 weeks of the study.
详细描述
Objective
To determine the effect of whole body vibration exercise on levels of TcPO2 measured in the feet of patients with type 2 diabetes, in order to create recommendations for prevention of diabetic foot.
Material and Methods
controlled open clinical trial consisting in 2 arms, as follows: 1) control group under care for type 2 diabetes, and 2) intervention group, who, in addition to the standard care, will undergo an exercise program of whole body vibration three times a week, with progressive intensity, for a period of 12 weeks. Partial pressure of transcutaneous oxygen (TcPO2) will be measured in the feet of the participants at baseline and after 12 weeks, with 40 patients per group.
Statistical analysis
demographic information of the subjects will be described as arithmetic means, standard deviation, percentages, frequencies. Comparison between groups will be done with Student t for independent data or Mann-Whitney U when convenient. Baseline and final measurements will be compared. inter and intra group comparisons will be made by repeated measurements. For qualitative values, chi square will be used. Multivariate analysis will be performed to control for confounding variables. The level of significance will be a value of 0.05.
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
- None
入排标准
- 年龄范围
- 40 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosis of type 2 diabetes less than or equal to six years, under care and having concluded the 4th or 5th medical visit.
- •Non-smokers.
- •Residents of Mexico City
- •Both sexes.
- •40 to 69 years old.
- •Agreeing to participate through signature of informed consent.
- •HbA1c between 6.0 and 9.0 %.
- •Blood pressure less than or equal to130/
- •Total cholesterol ≤ 240 mg/dL, triglycerides ≤300 mg/dL.
- •Stable weight over the last 6 months ( <10% variation).
排除标准
- •Patients with severe motor handicap and amputations of pelvic members.
- •With exposed lesions in subcutaneous tissue (ulcers) in the sole of the foot, diabetic foot (Wagner 3 or more) or intermittent claudication.
- •With important alterations in balance.
- •With a recent surgery.
- •Gravidity.
- •Deep venous thrombosis.
- •With pacemaker.
- •Recent myocardial ischemia.
- •Orthopedic implants.
- •Recently-placed mammary prosthesis.
- •Exoskeletal prosthesis.
- •Discopathies.
- •Neoplasia in the last 5 years.
- •History of 2 episodes of severe hypoglycemia in the last year.
- •Chronic kidney disease with creatinine clearance estimated at <60 ml/min.
- •Severe non-proliferative retinopathy, uncontrolled macular edema.
- •Hepatic failure (Child-Pugh "C") and/or heart failure (functional Class - NYHA-: III-IV).
- •Patients with hemoglobinopathies, severe anemia (≤7.5 g/dL), known hemolytic disease.
研究组 & 干预措施
Controls
Subjects under treatment for diabetes will receive the standard treatment for their condition.
Intervention
Subjects under treatment for diabetes not diagnosed for diabetic foot will receive the standard treatment plus exercise on a vibrator platform for a period of 12 weeks.
干预措施: Whole body Vibration exercise (Other)
结局指标
主要结局
Effect of whole body vibration on TcPO2 levels
时间窗: 12 weeks
To know the effect of whole body vibration on TcPO2 levels measured in the foot in patients with type 2 diabetes
次要结局
未报告次要终点
研究者
Gerardo Rodríguez Reyes
Medical Science Researcher
Instituto Nacional de Rehabilitacion