Resistance Training in Patients With Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Intraepidermal nerve fiber density (IENFD)
研究概览
简要总结
This is a population-based study of type 2 diabetes patients with and without neuropathy recruited from the Danish National Type 2 Diabetes cohort (DD2).
Diabetic patients with neuropathy may suffer from incapacitating symptoms such as pain, muscle weakness and impaired balance. Muscle weakness may cause reduced balance and postural instability increasing the risk of frequent falls and thereby increased morbidity and mortality. Thus, diabetic neuropathy is associated with significant disabilities having major impact on activities of daily living and quality of life.
The effects of resistance training on neuropathy symptoms, muscle strength and muscle structure in patients with and with diabetic neuropathy will be examined.
详细描述
Perspective: The studies will likely improve the understanding of diabetic neuropathy and the relation between risk of falls in patients with and without motor dysfunction. The results may enable new and more precise recommendations for exercise in diabetic patients with diabetic neuropathy. In addition, the results may lead to a better understanding of the mechanisms underlying the effects of training. The improvement of motor function may lead to improved gait stability, fewer fall injuries and better quality of life for type 2 diabetes patients, resulting in lower morbidity and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Clinical diagnosis of type 2 diabetes
排除标准
- •Neuropathy due to any other cause
- •Pacemaker
- •Comorbidity that contraindicates exercise
- •History of stroke with affection of the lower extremities
- •Ischemic heart disease
- •Any other neurological disease
- •Pregnancy
结局指标
主要结局
Intraepidermal nerve fiber density (IENFD)
时间窗: Change from baseline IENFD at 12 weeks
1-2 small biopsies of 3 mm will be performed before and after the 12-week training period to evaluate small nerve fiber function.
Muscle strength (isokinetic strength)
时间窗: Change from baseline IENFD at 12 weeks
Isokinetic dynamometry will be used to determine the maximal isokinetic strength of the flexors and extensors at the knee, hip and ankle.
次要结局
未报告次要终点