Effect of Resisted Blood Flow Restriction on Balance and Physical Function in Patients With Type II Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Balance assessed by Berg Balance Scale (0-56)
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of adding resisted blood flow restriction (BFR) training to a standard exercise program in adults aged 50-60 with Type 2 Diabetes Mellitus (T2DM). The main questions it aims to answer are:
Does adding BFR training significantly increase muscle strength compared to standard exercise alone? Does the BFR intervention lead to measurable improvements in balance and physical function? Researchers will compare a group performing standard therapeutic exercise combined with BFR to a control group performing the same exercise program without BFR to see if the BFR group achieves superior gains in strength and functional independence.
Participants will:
Complete a 12-week supervised exercise program in an outpatient setting. Wear compression cuffs on their limbs during low-intensity resistance exercises (for the BFR group).
Undergo assessments for muscle strength (via handheld dynamometry), balance, and functional mobility before and after the intervention.
详细描述
While high-load resistance training is the gold standard for improving muscle quality in Type 2 Diabetes Mellitus (T2DM), individuals with long-standing disease (5+ years) often present with microvascular complications or joint pain that make high-mechanical loads unsafe. Blood Flow Restriction (BFR) training uses a pneumatic cuff to induce metabolic stress-specifically lactate accumulation and growth hormone surges-allowing for muscle hypertrophy and strength gains at loads as low as 20-30% of a person's one-repetition maximum (1-RM).
Intervention Workflow 1. Baseline Assessment Phase
1-RM Testing: Participants will undergo 1-RM testing for lower-limb exercises (leg press and knee extension) to calibrate training loads.
Limb Occlusion Pressure (LOP): Using a personalized pressure system . the investigator will determine the minimum pressure required to fully occlude arterial flow in the sitting position.
12-Week Exercise Protocol Frequency: Sessions will occur 3 times per week on non-consecutive days. Repetition Scheme: Each BFR exercise will follow the standard 75-repetition protocol: one set of 30, followed by three sets of 15 repetitions (30-15-15-15).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 2 diabetes mellitus (T2DM) for at least 5 years. Age between 50 and 60 years. medically stable and cleared for participation in a low-to-moderate intensity exercise program.
- •Not currently engaged in structured resistance training. Able to walk independently without assistive devices. Berg Balance Scale (BBS) score between 21 and 40, indicating moderate balance impairment.
排除标准
- •History of recent cardiovascular events or uncontrolled hypertension. Peripheral arterial disease or deep vein thrombosis. Severe diabetic neuropathy or retinopathy. Musculoskeletal disorders affecting exercise performance. Cognitive impairments or psychiatric illness interfering with adherence to protocol.
- •Smokers. Uncontrolled diabetes.
结局指标
主要结局
Balance assessed by Berg Balance Scale (0-56)
时间窗: Pre-treatment and post-treatment (12 weeks)
Balance will be assessed using the Berg Balance Scale (BBS). The total score ranges from 0 to 56, with higher scores indicating better balance.
次要结局
- Quadriceps and calf muscle strength assessed using a Handheld Dynamometer(12 weeks)
- Total physical activity (MET-minutes/week) assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF)(12 weeks)
研究者
Khalid Abdelhakem Elsayed Ali
professor
Cairo University