The Effects of Diet and Exercise Interventions in Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire
研究概览
简要总结
This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.
详细描述
This study seeks to (1) compare the changes in 6-minute walk distance (6MWD) and physical function quality of life in patients with peripheral artery disease (PAD) following a combined intervention of the dietary approaches to stop hypertension (DASH) dietary program plus a home-based exercise program, and following a home-based exercise program alone; and (2) compare the changes in microvascular function and inflammation in patients following the combined DASH diet and home-based exercise program, and the home-based exercise program alone.
The investigators hypothesize that the combined DASH diet and exercise program will result in greater increases in 6MWD and in the physical function quality of life than the exercise program alone. Further, it is hypothesized that the combined DASH diet and exercise program will result in greater improvements in calf muscle oxygen saturation [StO2] following exercise, and in high-sensitivity C-reactive protein (hsCRP]) than the exercise program alone.
The home-based exercise program consists of intermittent walking to moderate claudication pain in a home-based setting. The DASH dietary program consists of the dietary approaches to stop hypertension diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of claudication,
- •Presence of PAD, defined by meeting at least one of the following criteria (ABI at rest < 0.90, or > 20% decrease in ABI following a heel-rise exercise test in patients with a normal ABI at rest (> 0.90), or history of peripheral revascularization.
排除标准
- •absence of PAD, defined by meeting all of the following 3 criteria (ABI at rest > 0.90), < 20% decrease in ABI following a heel-rise exercise test, and no history of peripheral revascularization,
- •non-compressible vessels (ABI > 1.40),
- •rest pain due to PAD (Fontaine stage III; Rutherford Grade II),
- •tissue loss due to PAD (Fontaine stage IV; Rutherford Grade III),
- •use of medications indicated for the treatment of intermittent claudication (cilostazol and pentoxifylline) initiated within three months prior to investigation,
- •peripheral revascularization within one month prior to investigation,
- •active cancer,
- •end stage renal disease defined as stage 5 chronic kidney disease,
- •medical conditions that are contraindicative for exercise according to the American College of Sports Medicine,
- •cognitive dysfunction (mini-mental state examination score < 24), and
- •failure to complete the baseline tests within three weeks.
研究组 & 干预措施
DASH Diet plus Home-Based Exercise
The DASH dietary program consists of a diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy, in which patients record daily servings of fruits and vegetables. The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.
干预措施: DASH Diet plus Home-Based Exercise (Behavioral)
Home-Based Exercise
The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.
干预措施: Home-Based Exercise (Behavioral)
结局指标
主要结局
Physical Function subscale of quality of life from the Medical Outcomes Study Short-Form 36 questionnaire
时间窗: 3 months
The change in the Physical Function subscale from the pre-test value to the post-test value
Peak Walking Time
时间窗: 3 months
The change in the time walked on a treadmill test
次要结局
- calf muscle oxygen saturation(3 months)
- 6-minute walk distance(3 months)
- high-sensitivity C-reactive protein(3 months)