The Acute Effects of Leg Heating and Transcutaneous Electrical Nerve Stimulation on Leg Blood Flow and Functional Capacity in Those With Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Distance walked during six-minute walk test
研究概览
简要总结
Peripheral arterial disease (PAD) is characterized by poor circulation in the lower extremities that often provokes claudication (leg pain, numbness, and heaviness) with physical exertion. The aim of this research protocol is to determine the effect of two non-invasive treatment modalities on leg blood flow and exercise capacity in those with PAD. Specifically, we are measuring popliteal artery blood flow (Doppler ultrasound), toe oxygen saturation, ankle-brachial index (ABI), and 6-minute walking distance (6MWD) in men and women who have intermittent claudication (Fontaine Stage II; Rutherford Category 1-2) in response to 15 or 45 minutes of lower limb heating and transcutaneous electrical nerve stimulation (TENS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent claudication (Fontaine Stage II)
- •Resting ankle-brachial index (ABI) < 0.90
- •Ability to walk > 60 meters in six minutes
排除标准
- •Body mass index (BMI) > 35 kg/m2
- •Severe exercise limitations (more than PAD) due to co-morbidity
- •Taking illegal/recreational drugs
- •Uncontrolled hypertension (>180/100 mmHg)
- •Severe peripheral neuropathy
- •Foot ulcers
- •Pregnant or breast feeding
研究组 & 干预措施
15 minute lower leg heating
干预措施: Lower leg heating (Behavioral)
45 minute lower leg heating
干预措施: Lower leg heating (Behavioral)
Control
15 minute lower leg TENS
干预措施: Lower leg transcutaneous electrical nerve stimulation (TENS) (Behavioral)
45 minute lower leg TENS
干预措施: Lower leg transcutaneous electrical nerve stimulation (TENS) (Behavioral)
结局指标
主要结局
Distance walked during six-minute walk test
时间窗: 35 minutes post-intervention/control
Distance walked during a self-paced six-minute walk
次要结局
- Time/distance to claudication during six-minute walk(35 minutes following each intervention and control period)
- Ankle brachial index (ABI)(Pre-intervention baseline and 20 minutes post-intervention/control)
- Toe oxygen saturation(Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control)
- Popliteal artery blood flow(Pre-intervention baseline; 10, 20, and 30 minutes post-intervention/control)