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临床试验/NCT05274009
NCT05274009尚未招募不适用

Evaluating the Efficacy of Cooling Centres for Limiting Heat Strain in Elderly Adults During Extreme Heat Events

University of Ottawa2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
2
主要终点
Core temperature (AUC)

研究概览

简要总结

With the increasing incidence and severity of extreme heat events accompanying climate change, there is an urgent need for sustainable cooling strategies to protect heat-vulnerable older adults, who are at increased risk of adverse health events during heat stress. Health agencies including the World Health Organization, the United States Centers for Disease Control and Prevention, and Health Canada currently recommend visiting a cooling centre or other air-conditioned location for 1-3 hours per day during extreme heat events to mitigate hyperthermia and strain on the cardiovascular system and therefore the risk adverse health events. However, our recent trial shows that while brief air-conditioning exposure is effective for reducing body temperature and cardiovascular burden in healthy older adults, the physiological impacts of cooling abate quickly following return to the heat. The purpose of this project is therefore to assess whether shorter but more frequent air-conditioning exposure provides more effective cooling than current recommendations (a single 1-3-hour cooling bout) in older adults with or without common chronic health conditions associated with increased vulnerability to extreme heat. This will be accomplished by evaluating physiological strain in older adults with and without diabetes and/or hypertension exposed for 8 hours to conditions reflective of extreme heat events in temperate, continental climates (35°C, 60% relative humidity). Participants will complete 3 separate simulated heat event exposures: i) a control trial (no cooling throughout the 8-hour heat event); ii) a recommended cooling trial (3 hours of heat exposure followed by 2 hours cooling); and iii) a hybrid cooling trial (2 hours of heat exposure followed by 1 hour cooling, another 2 hours heat exposure followed by 1 hour cooling, and a final 2-hour heat exposure).

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be informed of the study interventions before providing informed consent but will be blinded to the specific trial condition at each of the 3 laboratory visits (control, recommended cooling, hybrid cooling). Data will be blinded prior to analysis.

入排标准

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

入选标准

  • Adult aged 60-85 years
  • Male or female
  • Body mass index < 35 kg/m2
  • For participants with type 2 diabetes: at least one year lapsed since diagnosis and hemoglobin A1c 6.0-10.5%.
  • For participants with hypertension: at least one year lapsed since diagnosis or average resting blood pressure >140 systolic or >90 diastolic

排除标准

  • Currently smoking or quit <5 years ago
  • Moderate or serious medical conditions (other than Type 2 diabetes or high blood pressure), particularly those known to influence physiological responses to heat exposure (e.g., diagnosed heart disease, neurological disorders)
  • Heat adapted due to repeated exposure to hot environments (use sauna, recent travel to hot climates, other)
  • For participants with type 2 diabetes: "Brittle" diabetes: unpredictable hypo- & hyperglycemia. Severe cardiovascular autonomic or peripheral neuropathy (guidelines.diabetes.ca/cpg)

结局指标

主要结局

Core temperature (AUC)

时间窗: 8-hour heat exposure

Rectal temperature will be measured continuously throughout each exposure and the area under the curve will be calculated.

Core temperature (peak)

时间窗: 8-hour heat exposure

Peak rectal temperature measured during the 8-hour heat exposure.

次要结局

  • Heart rate temperature (peak)(8-hour heat exposure)
  • Mean skin temperature(Before and continuously throughout each 8 hour exposure)
  • Body fluid loss(Every hour during the 8-hour heat exposure)
  • Stand test: Systolic response to standing(Prior to and following the 8-hour heat exposure)
  • Heart rate (AUC)(8-hour heat exposure)
  • Arterial blood pressures(Every hour during the 8-hour heat exposure)
  • SDNN(Every hour during the 8-hour heat exposure)
  • RMSSD(Every hour during the 8-hour heat exposure)
  • Rate pressure product(Every hour during the 8-hour heat exposure)
  • Stand test: 30:15 ratio(Prior to and following the 8-hour heat exposure)
  • Baroreflex sensitivity(Prior to and following the 8-hour heat exposure)
  • Change in plasma volume(Prior to and following the 8-hour heat exposure)

研究者

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

Glen P. Kenny

Full Professor, University Research Chair

University of Ottawa

研究点 (2)

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