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临床试验/NCT03900832
NCT03900832已完成早期 1 期

Effects of Heating on Exercise Pressor Reflex in Peripheral Artery Disease: Exercise Ability

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2019年5月15日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
33
试验地点
2
主要终点
Heart Rate in beats per minute

研究概览

简要总结

The study objectives of this projects are to examine the hypothesis that the sympathetic and blood pressure responses to exercise will be attenuated during and after heat exposure in patients with peripheral artery disease, via altering the sensitivity of the muscle afferent receptors.

详细描述

Peripheral arterial disease (PAD) affects 8-12 million Americans and its cardinal symptom is leg pain during exercise, termed "intermittent claudication". The diagnosis of PAD involves measuring the ankle-brachial index (ABI, i.e. the systolic pressure in the ankle divided by the systolic pressure in the arm); values below 0.9 are indicative of large vessel obstruction. Intermittent claudication is the most common symptom of this disease and it regularly occurs during exercise/physical activity but is relieved promptly by rest. Previous studies suggest that as the exercise pressor reflex is activated in patients with PAD, BP and heart rate (HR) are exaggerated. The BP rises during walking in the PAD patients were significantly greater than that seen in healthy control subjects. A recent human study from our group further indicates that an early BP response occurred during plantar flexion exercise before claudication was noted by the subjects, which may suggest that the accentuated BP response was due to an augmented muscle mechanoreflex in PAD. Moreover, another recent study from our group also showed that PAD patients have augmented renal vasoconstriction during plantar flexion exercise.

It has been shown that exercise has benefits for patients with PAD. However, exercise becomes limited due to the pain and fatigue associated with the disease. Moreover, the augmented pressor response to exercise in PAD may increase the risk for the end organ damage (e.g. brain and/or heart). Thus, finding alternate/complimentary interventions that modulate the cardiovascular system and autonomic nervous system, and can be tolerated by the patients, would be beneficial.

One possible intervention is heat exposure, since acute bouts of exercise and acute heat exposure have similar acute effects on both the autonomic and cardiovascular systems. For example, both exercise and heat exposure increase body temperature, increase HR, increase cardiac output (CO), increase left ventricular ejection fraction (EF), and enhance myocardial function. In the peripheral circulation, both exercise and heat exposure increase limb blood flow , muscle blood flow, and skin blood flow. Moreover, recent studies suggest that whole body exposure improves the endothelium function in PAD patients (e.g. activates endothelial progenitor cells CD34+).

However, the effect of heat treatment on the ability of walking of PAD patients has not been examined. Moreover, it is unknown if heating can normalize/decrease the accentuated the pressor responses to exercise in PAD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

盲法说明

Subjects will be aware if they are being heated or not, but data analysis process is blinded.

入排标准

年龄范围
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All subjects
  • Capable of giving informed consent
  • Any race or ethnicity
  • Men and women age 21- 85 years (inclusive)
  • Fluent in written and spoken English
  • Patients with peripheral arterial disease (PAD)
  • Diagnosed with PAD (i.e., ankle-brachial index below 0.9)
  • Fontaine stage II or less - no pain while resting
  • Satisfactory history and physical exam
  • Healthy subjects
  • Satisfactory history and physical examination
  • Free of acute medical conditions

排除标准

  • For patients with PAD and Healthy subjects
  • Age < 21 years
  • Pregnant or nursing women
  • Decisional impairment
  • Prisoners
  • For patients with PAD
  • History of CAD with symptoms of unstable angina or myocardial infarction (<6 months)
  • History of epilepsy or seizure disorders
  • For healthy subjects
  • Any other chronic diseases (heart, lung, neuromuscular disease or diabetes)

结局指标

主要结局

Heart Rate in beats per minute

时间窗: Recorded continuously during the 3-4 hour study visit

Electrocardiogram (ECG) patches attached to a Cardiocap will monitor heart rat

Blood pressure in mmHg

时间窗: Recorded continuously during the 3-4 hour study visit

Cuffs placed on a finger and arm will monitor blood pressure.

Walking time in minutes

时间窗: Recording walking time to fatigue (up to 22 minutes maximum) during of every 3-4 hour study visit.

Walking time on treadmill using Gardner protocol

次要结局

  • Near infrared spectroscopy (NIRS) in arbitrary units(Recorded continuously during the 3-4 hour study visit)
  • Internal Temperature in degrees C(Recorded continuously during the 3-4 hour study visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jian Cui

Associate Professor of Medicine

Milton S. Hershey Medical Center

研究点 (2)

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