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临床试验/NCT06420752
NCT06420752招募中2 期

Passive Stretching and Dietary Nitrate Rescue Functional Capacity in Peripheral Arterial Disease

University of Wisconsin, La Crosse2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年5月20日最近更新:
适应症

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
64
试验地点
2
主要终点
Functional capacity

研究概览

简要总结

Peripheral artery disease (PAD) leads to higher mortality rates and strains healthcare systems due to increased costs. It causes leg pain during walking due to reduced blood flow. Nitric oxide (NO) deficiency contributes to vascular issues in PAD, with few effective treatments available. Passive calf muscle stretching boosts NO levels, vascular health, and walking ability in PAD patients. However, the inflammatory processes underlying these improvements are unclear. This study aims to track inflammatory markers and cardiovascular changes during 12 weeks of passive stretching. Additionally, combining stretching with dietary nitrate could further enhance walking capacity by reducing reactive oxygen species. The study will monitor inflammation, vascular function, and oxidative capacity to understand the effects on functional ability in PAD patients. This research is crucial for improving physical function and addressing exercise intolerance in PAD.

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
Double (Participant, Investigator)

盲法说明

Double blind placebo controlled.

入排标准

年龄范围
40 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ankle-brachial index of 0.90 or less Stable condition for at least 3 months

排除标准

  • Habitual exercise or cardiovascular rehabilitation program during the past 3 months Critical limb ischemia, amputation, or leg pain at rest Major surgery or lower extremity revascularization in the last 3 months Heart Failure Kidney disease Beet allergy Crohn's Current smoker

结局指标

主要结局

Functional capacity

时间窗: 12-14 weeks

6-minute walking distance will be assessed prior to an at various time points during the 12-week study

次要结局

  • Vascular function(12-14 weeks)
  • Inflammatory markers(12-14 weeks)

研究者

发起方
University of Wisconsin, La Crosse
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Caldwell

Assistant Professor

University of Wisconsin, La Crosse

研究点 (2)

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