Effects of Blood Flow Restriction Training on Glycemic Control, Nerve Conduction, Functional Outcomes and Quality of Life in Individuals With Type 2 Diabetes Peripheral Neuropathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin
研究概览
简要总结
Diabetic peripheral neuropathy is one of the most prevalent complications of Type 2 Diabetes Mellitus. Peripheral neuropathy is caused by unavailability of glucose in cells and low metabolism. The Blood flow restriction training cause glucose diffusion into cell and Angiogenesis.
详细描述
The objective of this study will be to determine the effect of Blood flow restriction training on peripheral neuropathy in diabetes II patients. The study will be randomized controlled trial. Sample size will be determined by pilot study.
The single blinding will be applied. Randomization will be done by lottery method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes (≥5 years) patients diagnosed
- •random blood glucose ≥ 11.1mmol/L;
- •fasting blood glucose ≥ 7.0 mmol/L
- •Haemoglobin A1c 6.5%-9.5%. 2) Can walk independently, no severe joint limitations
- •Can safely perform resistance training
- •Stable diabetic & neuropathy meds for 3+ months
排除标准
- •suffers frequent hypoglycaemia,
- •severe diabetes complications
- •Diagnosed cases of neuromuscular disorders
- •history of stroke/DVT
研究组 & 干预措施
BFR with low resistance high repetition exercises
干预措施: BFR with low resistance high repetition exercises (Combination Product)
low resistance high repetition exercises
干预措施: low resistance high repetition exercises (Combination Product)
结局指标
主要结局
Glycated Hemoglobin
时间窗: 12 Months
HbA1c reflects the average blood glucose concentration over the 3 months by measuring the percentage of hemoglobin that is glycated. Scoring is as following: below 5.7% being normal, 5.7%-6.4% prediabetes, and 6.5% higher diabetes
Nerve Conduction Velocity
时间窗: 12 Months
Nerve conduction velocity measures the speed at which an electrical impulse travels along a peripheral nerve and is used to assess the functional integrity of peripheral nerves. It is particularly useful for detecting and quantifying peripheral nerve dysfunction in diabetic neuropathy. Scoring: NCV is recorded in m/s; typical adult lower reference limits are approximately ≥40-45 m/s for lower-limb motor nerves and ≥40-50 m/s for sensory nerves, with values below the laboratory-specific reference range considered abnormal.
Numeric pain rating scale (NPRS)
时间窗: 12 Months
It is used to assess pain intensity Scoring is as following : its 11-point scale (0-10) 0 means "no pain" and 10 represents "worst possible pain."
The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) instrument
时间窗: 12 Months
The Norfolk QOL-DN measures the impact of diabetic neuropathy on overall health-related quality of life Scoring is as following :Total score of tool is 160. 0-40 score mean Mild or no impairment,41-80 score mean Moderate impairment and 81-160 mean Severe impact on quality of life.
次要结局
未报告次要终点
研究者
Muhammad Naveed Babur
Principal Investigator
Superior University