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临床试验/NCT04284397
NCT04284397招募中早期 1 期

Identification of Critical Thermal Environments for Aged Adults

Penn State University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2020年12月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
190
试验地点
1
主要终点
Temperature and humidity limits for maintaining stable core temperature

研究概览

简要总结

This study evaluates critical environmental limits (temperature and humidity) above which older adults are unable to effectively thermoregulate. Participants will exercise in a series of different environmental conditions to identify combinations of temperature and humidity above which age-related physiological changes cause uncompensable heat stress, resulting in increased risk of heat illness.

详细描述

The earth's climate is warming well above historical averages, and there is an increased frequency, duration, and severity of heat waves. At the same time, the world's population is rapidly aging. Aging is associated with reductions in thermoregulatory capacity due to reductions in sweating and skin blood flow. For this reason, people ≥65 years exhibit exponentially larger increases in morbidity and mortality during heat waves than younger individuals, with the large majority of excess deaths during heat waves occurring in the elderly.

Compounding the physiological effects of primary aging, co-morbidities and common classes of drugs taken by older adults can further compromise their thermoregulatory function. One such class of medications is cyclooxygenase inhibitors, including aspirin (ASA) and other platelet inhibitors. Provocative data published by our lab indicate that platelet inhibitors including ASA increase the rate of heat storage during passive heat stress by ~25%. Following current clinical guidelines, nearly 40% of US adults over the age of 50 engage in an aspirin therapy regiment for the primary or secondary prevention of cardiovascular disease.

Although there is compelling evidence that aging is associated with decreased heat dissipation and elevated risk of heat illness in hot ambient conditions, the significant question remains: In what specific environments does this age disparity begin to occur? The goal of the current study is to identify and model ambient conditions that are unsafe for older adults. A second aim of the study is to determine the effects of the commonly used platelet inhibitor, acetylsalicylic acid (ASA), on age-specific critical environmental limits.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Adults aged 18 and older (those 40+ years of age must be cleared by collaborating physician)
  • All premenopausal women will be eumenorrheic (by survey)
  • Asymptomatic and no signs/symptoms of disease according to the American College of Sports Medicine 10th edition Guidelines for Exercise Testing and Prescription

排除标准

  • Medications that affect thermoregulatory or cardiovascular responses to exercise
  • Any contraindications to low intensity physical activity on the Physical Activity Readiness Questionnaire
  • Any mobility restrictions that interfere with low intensity physical activity
  • Pregnant or planning to become pregnant in the next 12 months
  • Prior diagnosis of cancer, cardiovascular disease, diabetes, or metabolic syndrome
  • Illegal/recreational drug use
  • History of Chron's disease, diverticulitis, or similar gastrointestinal disease
  • Abnormal resting or exercise electrocardiogram (ECG)

研究组 & 干预措施

Critical Environmental Limits

Experimental

Subjects will perform exercise at ~200-300W with ambient temperature or humidity increasing every 5 min throughout the trial until core temperature begins to rise.

干预措施: Control (Other)

Aspirin Supplementation

Experimental

After a minimum of 7 days of daily, low-dose aspirin ingestion, older subjects will repeat critical environmental limits trials. As before, subjects will perform exercise at ~200-300W with ambient temperature or humidity increasing every 5 min throughout the trial until core temperature begins to rise.

干预措施: Low dose ASA (Drug)

结局指标

主要结局

Temperature and humidity limits for maintaining stable core temperature

时间窗: Through study completion, an average of 1 year.

Core temperature will be measured throughout exercise. The point at which heat stress becomes uncompensable will be determined for each environmental and exercise condition by assessing the combination of temperature and humidity at which core temperature begins to rise.

次要结局

  • Skin temperature(Continuous throughout visit until completion of exercise; an average of 2 hours.)
  • Core temperature(Continuous throughout visit until completion of exercise; an average of 2 hours.)
  • Sweat rate(Immediately before and immediately after exercise.)

研究者

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

W. Larry Kenney

Professor

Penn State University

研究点 (1)

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