jRCT1050210193尚未招募不适用
Study on the effect of the original exercise program on muscle strength, muscle mass, and metabolic parameters
Hitoshi Nishizawa0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Plasma hypoxanthine (HX), xanthine (Xan), uric acid (UA), and xanthine oxidoreductase (XOR) activity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Basic Science
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 74age old under（—）
- 性别
- All
入选标准
- •Type 2 diabetic patients admitted to the Department of Diabetes, Endocrinology, and Metabolism, Osaka University Hospital (regardless of gender), who meet the following criteria
- •Patients aged 20 to 74 years
- •Patients diagnosed with type 2 diabetes by the doctors
- •Patients who have agreed to participate in the program
排除标准
- •Patients with type 1 diabetes or secondary diabetes
- •Fasting plasma glucose; 250mg/dl or more
- •Resting blood pressure; 180/110mmHg or more
- •Diabetic nephropathy with stage 3 or more (urinary albumin/creatinine ratio; 300 mg/g Cr or more or persistent proteinuria)
- •Severe neuropathy (sensory and autonomic neuropathy)
- •Unstable diabetic retinopathy such as preproliferative or proliferative retinopathy
- •Unstable macroangiopathy such as cardiovascular disease and peripheral arterial disease
- •Severe liver damage (decompensated cirrhosis, etc.)
- •Heart failure (NYHA; II or more or patients on limited physical activity)
- •Patients at high risk of hypoglycemia
- •Patients whose condition is thought to worsen by whole body vibration (e.g. dizziness, etc.)
- •Patients who are at risk of falling and are judged to have difficulty in performing whole body vibration
- •Female patients who are pregnant or potentially pregnant and are lactating
- •Patients who are judged by the doctors to be inappropriate for participation in the program due to complications (e.g. blindness, decreased ADL, scheduled surgery, uncontrollable active infections, etc.)
- •Patients who are difficult for the doctors to assess the effectiveness of the program (e.g. complications of psychiatric disorders or mental disorders, having difficulty in communicating with medical staff, alcohol-dependent / drug-dependent, planning a long trip during the program, opposed by their families, and a rapid weight loss more than 4.5 kg within 3 months, etc.)
- •Patients that the primary investigator or the doctors consider to be inappropriate for other reasons
结局指标
主要结局
Plasma hypoxanthine (HX), xanthine (Xan), uric acid (UA), and xanthine oxidoreductase (XOR) activity
时间窗: before and after WBV exercise
Plasma hypoxanthine (HX), xanthine (Xan), uric acid (UA), and xanthine oxidoreductase (XOR) activity before and after WBV exercise
Body composition
Body composition evaluated by In Body
Grip strength
Grip strength
Lower limb extension
Lower limb extension
Thigh circumference
Thigh circumference
次要结局
- Exercise function test
研究者
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