The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Peak Walking Time
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 Non-Ischemic Exercise (NICE) program to improve exercise and vascular outcome measures in patients with peripheral artery disease (PAD).
详细描述
Specific Aims. The investigator proposes to test our central hypothesis that the NICE intervention performed without inducing leg ischemia and its' damaging sequela will be a superior exercise paradigm to increase peak walking time and HRQoL more than the Standard ischemic and painful exercise paradigm via greater improvement in microvascular mechanisms. This clinically relevant hypothesis will be tested through the following aims:
Aim 1 (Exercise Outcomes) To compare the changes in ambulation and HRQoL in PAD patients randomized to either the NICE slow walking program or to the Standard program of ischemic and painful exercise.
Aim 2a (Vascular Outcomes) To compare the changes in local microvascular function of the lower extremities, inflammation and oxidative stress in patients following the NICE program, and following the Standard ischemic and painful program.
Aim 2b (Exploratory Aim) To explore whether the changes in local microvascular function and systemic vascular biomarkers are associated with the changes in peak walking time following the NICE and Standard programs, and whether the association is stronger following the NICE program.
Methods. This is a 3-month, patient-oriented, translational, comparative effectiveness randomized controlled trial. One-hundred patients will be randomized into either the NICE program (N=50) or the Standard exercise program (N=50). All patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.
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 assessed by the Walking Impairment Questionnaire,
- •ambulatory leg pain in either one or both legs consistent with intermittent claudication confirmed during a screening graded treadmill test using the Gardner-Skinner protocol,
- •an ABI <= 0.90 at rest or > 20% decrease in ankle systolic blood pressure in either one or both legs immediately following the treadmill exercise test.
- •age >= 40 years.
排除标准
- •absence of PAD (ABI > 0.90 at rest and ankle systolic blood pressure < 20% decrease after exercise,
- •inability to obtain an ABI measure due to non-compressible vessels (ABI > 1.40),
- •asymptomatic PAD (Fontaine Stage I) determined from the medical history and verified during the graded treadmill test,
- •rest pain due to PAD (Fontaine stage III)
- •tissue loss due to PAD (Fontaine stage IV)
- •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, or peripheral revascularization performed during the study,
- •exercise tolerance limited by any disease process other than PAD,
- •active cancer,
- •kidney failure defined as stage 5 chronic kidney disease,
- •a calf skin fold measurement > 25 mm, because of potential interference with the light path of the NIRS probe from penetrating the subcutaneous tissue,
- •pulse arterial oxygen saturation of the index finger < 95% because of potential deleterious effect on calf muscle StO2 from poor pulmonary gas exchange, and
- •failure to complete the baseline run-in phase within three weeks.
研究组 & 干预措施
Non-Ischemic Exercise (NICE) exercise program
Patients will perform supervised treadmill walking for 3 months. Patients randomized to the NICE program will walk intermittently at a slow speed of approximately 1.4 mph for only 2-3 minute bouts that do not elicit claudication pain.
干预措施: Exercise (Behavioral)
Standard exercise program
Patients will perform supervised treadmill walking for 3 months. Patients randomized to the Standard program will walk intermittently at a speed of approximately two mph to near maximal claudication pain.
干预措施: Exercise (Behavioral)
结局指标
主要结局
Peak Walking Time
时间窗: 3 months
The change in peak walking time from the pre-test value to the post-test value (seconds)
Calf Muscle Oxygen Saturation
时间窗: 3 months
The change in calf muscle oxygen saturation value during exercise from the pre-test value to the post-test value (% saturation)
次要结局
- plasma C-Reactive Protein(3 months)
- 6-Minute Walk Distance(3 months)