Effects of Whole-body Vibration Therapy on Type 2 Diabetic Patients with and Without Polyneuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 6 min walk test
研究概览
简要总结
The aim of this study is to show how whole body vibration training practiced for 12 weeks affects the levels of inflammatory biomarkers such as C reactive protein (CRP) and, interleukin-6 (IL-6), in Type 2 diabetic patients (T2DM) with and without peripheral neuropathy.
详细描述
Volunteers with type 2 diabetes mellitus with and without peripheric neuropathy will be evaluated in terms of any contra-indication that will restrain them from making exercise with whole body vibration device. 60 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 20 participants. 1st group will include type 2 diabetic patients with peripheric neuropathy and 2nd and 3rd groups will include type 2 diabetic patients without neuropathy. Patients in group 1 and 2 will make static isometric exercises on vibration platform whereas patients in group 3 will make the same exercises on land in the hospital setting. Participants will be requested to complete 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with physical measures such as waist and hip circumference, 6-minute walk test, body composition measured by bioimpedance, muscle thickness, and blood tests to measure inflammatory biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must stand and walk o without using an assistive device.
- •Participants must have a weight of less than 120 kg.
排除标准
- •T2DM patients with advanced cardiovascular, renal, hepatic disease
- •T2DM patients with diabetic retinopathy or nephropathy
- •T2DM patients with untreated hypertension, rhythm disorders, and those who have undergone bypass surgery
- •T2DM patients with ischemic changes in the resting ECG
- •T2DM patients with untreated hypoglycemia or orthostatic hypotension
- •T2DM patients who are unable to walk independently, or use of canes, crutches or wheelchairs
- •T2DM patients who have open ulcers or wounds on load-bearing surfaces
- •T2DM patients with inflammatory rheumatic diseases such as rheumatoid arthritis
- •T2DM patients with active infectious disease
- •T2DM patients with high risk of thrombosis, those with deep vein thrombosis
- •T2DM patients who carry a pacemaker, prosthesis, intrauterine device or metal implant,
- •T2DM patients with a history of cancer
- •T2DM patients with severe migraine, epilepsy, stroke or other neurological disorders, those who have undergone brain surgery
- •T2DM patients with non-diabetic neuropathy due to reasons such as HIV, AIDS, alcohol, uremia
- •T2DM patients with cognitive impairment
- •T2DM patients who are on psychotropic or neurotoxic therapy
- •T2DM patients with advanced balance problems
- •T2DM patients who are pregnant or breastfeeding mothers
- •T2DM patients who are organ transplant recipients
- •T2DM patients with hernia
- •T2DM patients with kidney or bladder stones
- •T2DM patients who are exposed to mechanical vibration due to their job
结局指标
主要结局
6 min walk test
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
GULIN FINDIKOGLU
Assoc Prof Dr
Pamukkale University