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临床试验/NCT06142890
NCT06142890已完成不适用

Evaluating the Efficacy of Ceiling Fans for Limiting Heat Strain in Elderly Adults During Bed Rest in an Extreme Heat Event

University of Ottawa2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年12月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Core temperature (peak)

研究概览

简要总结

With the increasing regularity and intensity of hot weather and heat waves, there is an urgent need to develop heat-alleviation strategies able to provide targeted protection for heat-vulnerable older adults. While air-conditioning provides the most effective protection from extreme heat, it is inaccessible for many individuals. Air-conditioning is also energy intensive, which can strain the electrical grid and, depending on the source of electricity generation, contribute to green house gas emissions. For these reasons, recent guidance has recommended the use of electric fans as a sustainable cooling alternative. While fans may increase sweat evaporation and heat loss in healthy, young adults, evidence supporting their use in older adults is scarce. Further, studies show that when environmental temperature exceeds skin temperature, fans are not effective and can even exacerbate hyperthermia in older adults. While older adults only account for ~13% of the population, they account for ~40% off all hospitalizations. In the context of sustainable cooling interventions, this is of particular importance given that many hospitals and long-term care homes do not have air-conditioning and rely on ceiling fans to enhance sweat evaporation while participants are bed-resting. While recent biophysical modelling has suggested that pedestal fans likely provide a clinically meaningful cooling effect (proposed to be ≥0.3°C) in temperatures below ~34°C in older adults, the efficacy of ceiling fans in mitigating heat strain in these conditions is currently unknown.

To address these knowledge gaps, this randomized crossover trial will evaluate body core temperature, cardiovascular strain, orthostatic intolerance, dehydration, and thermal comfort in adults aged 65-85 years exposed for 8-hours to conditions experienced during indoor overheating occurring during a heat wave in a temperate continental climate (31°C, 45% relative humidity). Each participant will complete two randomized exposures that will differ only in the airflow generated by a ceiling fan: no airflow (control) or standard airflow. Participants will remain in a supine position for the duration of the 8-hour exposure period, except for during hour 7 when they will complete a series of cardiovascular autonomic response tests.

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 masked to the order of the arms until exposure (i.e., participants will not know the fan conditions before entering the environmental chamber). Data will be blinded prior to analysis (including during statistical analysis).

入排标准

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

入选标准

  • Male or female adults.
  • Aged 65-85 years.
  • Non-smoking.
  • English or French speaking.
  • Ability to provide informed consent.

排除标准

  • Physical restriction (e.g., due to disease: intermittent claudication, renal impairment, active proliferative retinopathy, unstable cardiac or pulmonary disease, disabling stroke, severe arthritis, etc.).
  • Use of or changes in medication judged by the patient or investigators to make participation in this study inadvisable (e.g., medications increasing risk of heat-related illness; beta blockers, anticholinergics, etc.)
  • Cardiac abnormalities identified via 12-lead ECG during an incremental exercise test to volitional fatigue (performed for all participants).
  • Peak aerobic capacity (VO2peak), as measured during an incremental exercise test to volitional fatigue, exceeding the 50th percentile of age- and sex-specific normative values published by the American College of Sports Medicine (ACSM).

结局指标

主要结局

Core temperature (peak)

时间窗: End of heat exposure (hour 8)

Peak rectal temperature (15 min average) during exposure. Rectal temperature is measured continuously throughout each simulated heat wave.

次要结局

  • Heart rate (end-exposure)(End of heat exposure (hour 8))
  • Systolic Response to Standing From Supine(During heat exposure (hour 7))
  • Diastolic blood pressure(End of heat exposure (hour 8))
  • Whole-body sweat rate(End of heat exposure (hour 8))
  • Fluid loss(End of heat exposure (hour 8))
  • Change in plasma volume(End of heat exposure (hour 8))
  • Core temperature (AUC)(End of heat exposure (hour 8))
  • Core temperature (end-exposure)(End of heat exposure (hour 8))
  • Heart rate (peak)(End of heat exposure (hour 8))
  • Heart rate (AUC)(End of heat exposure (hour 8))
  • Cardiac Response to Standing From Supine (30:15 Ratio)(During heat exposure (hour 7))
  • Systolic blood pressure(End of heat exposure (hour 8))
  • Rate pressure product (end-exposure)(End of heat exposure (hour 8))
  • Heart rate variability: SDNN (end-exposure)(During heat exposure (hour 7))
  • Heart rate variability: RMSSD (end-exposure)(During heat exposure (hour 7))
  • Thermal comfort scale (end-exposure)(End of heat exposure (hour 8))
  • Fluid consumption(End of heat exposure (hour 8))
  • Orthostatic intolerance symptoms assessment(During heat exposure (hour 7))

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 of Ottawa

研究点 (2)

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