Heat Waves and the Elderly - Cooling Modalities
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
The purpose of this study is to assess how well cooling modalities work in reducing cardiovascular stress of the elderly to heat wave conditions
Eligibility criteria
This trial accepts healthy volunteersQualifiers
65 years of age or older
Free of any significant underlying medical problems based upon a detailed medical history and physical exam
Disqualifiers
Known heart disease
Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc;
Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram.
Current smokers, as well as individuals who regularly smoked within the past 3 years
Trial design
Design model
Crossover
Treatments tested in this trial
Water Spray
Other interventionParticipants will receive water spraying on their body throughout the climate chamber exposure.
Fan
Other interventionParticipants will be exposed to a fan throughout the climate chamber exposure.
Water Spray and Fan
Other interventionParticipants will receive both water spraying and a fan throughout the climate chamber exposure.
Control
Other interventionParticipants will NOT receive either water spray or a fan exposure.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Very hot and dryExperimental treatment 4 interventions
Group B: Hot and humidExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in core body temperature
Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer
Time frame
Body core temperature will be obtained within 60 min before the heat wave exposure after the 3 hour heat wave exposure.2
Change in left ventricular function
Measures of left ventricular function, such as ventricular wall motion and ventricular filling, will be obtained from echocardiography images.
Time frame
Within 60 minutes before each simulated heat wave exposure, around minute 90 of the heat wave exposure, and at the end of the 3 hour heat wave exposureSecondary outcomes
1
Heart rate
Heart rate will be measured from ECG electrodes attached to the participant
Time frame
Prior to and throughout each simulated heat wave exposure; approximately 420 minutes2
Cardiac output
Cardiac output (how much blood is ejected from the heart) will be measured using 3D echocardiography.
Time frame
Within 60 minutes before each simulated heat wave exposure and during each simulated heat wave exposure (up to 3 hours)3
Arterial blood pressure
Arterial blood pressure will be measured using a standard arm blood pressure cuff.
Time frame
Prior to and throughout each simulated heat wave exposure; an average of 480 minutes4
Whole body sweat rate
Whole body sweat rate will be measured by through nude weight of the participant.
Time frame
Within 60 minutes before each simulated heat wave exposure and within 30 minutes after each heat wave exposure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov