Efficacy of Blood Flow Restriction Training versus Resistance Training in Improving Hand Grip Strength in Patients with Diabetic Neuropathy –A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hand grip strength, pain, hand function, quality of life
研究概览
简要总结
This study is compare the effect of blood flow restriction training and resistance training in improving the hand grip strength in patients with diabetic neuropathy.
Study Design & Setting:
This randomized controlled trial will be conducted in the Neurology and Medicine OPDs at Uttar Pradesh University of Medical Sciences, Saifai, Etawah. Sixty patients aged 40–65 years with clinically diagnosed diabetic neuropathy (HbA1c 6.5–11.0%) and hand grip strength deficits will be included based on inclusion/exclusion criteria.
Sampling & Randomization: Using simple random sampling and a computer-generated randomization list, 60 patients will be equally assigned to two groups (n=30 each): Group A (BFRT) and Group B (RT). The sample size was calculated using standard deviation (8.5 kg), clinically significant difference (6.5 kg), 80% power, and 5% significance level.
Intervention Protocol:
- Group A (BFRT): Participants will perform low-load resistance exercises (20–40% 1RM) with a pneumatic cuff on the proximal forearm. Each session lasts 30 minutes, 3 times per week for 4 weeks.
- Group B (RT): Participants will perform moderate-load resistance exercises (50–70% 1RM) without blood flow restriction, on the same schedule as Group A. Both groups receive a home exercise program.
Outcome Measures: Primary outcomes include hand grip strength (via dynamometer), functional hand ability, pain (Neuropathic Pain Scale), and quality of life (CAP-PRI questionnaire). Data will be collected at baseline, 2 weeks, and 4 weeks.
Statistical Analysis: Data will be analyzed using SPSS/R. Between-group comparisons will use inferential statistics, with significance set at p < 0.05. Multivariate analysis may adjust for confounders.
Hypotheses:
- H1: BFRT is more effective than RT in improving hand grip strength.
- H0: There is no difference between BFRT and RT.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Diabetic neuropathy by neurologist and physician after clinical examination. (HbA1c levels between 6.5%.
- •Age- 40- 65 years.
- •Documented hand grip strength deficits, as measured by a dynamometer.
- •Provide informed consent.
排除标准
- •History of cardiovascular diseases or contraindications to exercise.17
- •Blow 40 years and above 65 years
- •Uncontrolled diabetes or other contraindications to exercise (hypertension , fever etc)
- •History of musculoskeletal injuries in hand grip strength outcomes.
- •Severe peripheral vascular disease (DVT, varicose vain, Raynaud’s disease etc.).
结局指标
主要结局
Hand grip strength, pain, hand function, quality of life
时间窗: At Baseline at 2 weeks and 4 weeks
次要结局
未报告次要终点