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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG069005-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to assess the cardiovascular responses of the elderly to heat wave conditions
Heat waves are lethal and cause a disproportionate number of deaths in the elderly relative to any other age group. It is important to note that such deaths are primarily cardiovascular, not hyperthermia itself, in origin. Nevertheless, we know relatively little about the effects of aging on cardiovascular function during actual heat wave-like conditions. The central hypothesis of this work is that the elderly exhibit greater cardiovascular stress during heat wave conditions. Aim 1 will test the hypothesis that recognized impairments in thermoregulatory capacity in the elderly will culminate in heightened cardiovascular stress during prolonged exposure to heat wave conditions. Comprehensive cardiovascular and thermal responses in the elderly, relative to younger adults, will be evaluated during exposure to two prolonged heat wave conditions: hot and humid (replicating the 1995 Chicago heat wave) and very hot and dry (replicating the 2018 Los Angeles heat wave). The expected outcome from this body of work will re-shape our understanding of the consequences of aging on cardiovascular function during heat waves
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Younger participants: Hot/Dry then Hot/Humid | Other | Individuals aged 18-39 years who completed the hot/dry trial first and the hot/humid trial second. |
|
| Older participants: Hot/Dry then Hot/Humid | Other | Individuals aged 65 years or older who completed the hot/dry trial first and the hot/humid trial second. |
|
| Younger participants: Hot/Humid then Hot/Dry | Other | Individuals aged 18-39 years who completed the hot/humid trial first and the hot/dry trial second. |
|
| Older participants: Hot/Humid then Hot/Dry | Other | Individuals aged 65 years or older who completed the hot/humid trial first and the hot/dry trial second. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hot and Humid Trial | Other | Individuals will be exposed to a simulated heat wave (hot and humid) condition. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Core Body Temperature | Core body temperature will be measured via a telemetric pill or rectal temperature probe. | Prior to and after the 3-hour simulated heat wave exposure. |
| Change in Peak Mitral Annular Systolic Velocity (S') | Change in peak mitral annular systolic velocity was measured by tissue doppler imaging. | Prior to, during, and after each simulated heat wave exposure; approximately 20 min each |
| Measure | Description | Time Frame |
|---|---|---|
| Ending Skin Temperature | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | At the end of the 3-hour simulated heat wave exposure. |
| Ending Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Exercise and Environmental Medicine | Dallas | Texas | 75231 | United States |
18 participants were either screened out or withdrew before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Younger Participants: Hot and Humid First, Then Hot and Dry | Individuals aged 18-39 years that had the hot/humid trial first and the hot/dry trial second. |
| FG001 | Younger Participants: Hot and Dry First, Then Hot and Humid | Individuals aged 18-39 years that had the hot/dry trial first and the hot/humid trial second. |
| FG002 | Older Participants: Hot and Humid First, Then Hot and Dry | Individuals aged 65 years or older that had the hot/humid trial first and the hot/dry trial second. |
| FG003 | Older Participants: Hot and Dry First, Then Hot and Humid | Individuals aged 65 years or older that had the hot/dry trial first and the hot/humid trial second. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (3 Hours) |
| |||||||||||||
| Washout (1 Week) |
| |||||||||||||
| Second Intervention (3 Hours) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Younger Participants: Hot and Humid First, Then Hot and Dry | Individuals aged 18-39 years that had the hot/humid trial first and the hot/dry trial second. |
| BG001 | Younger Participants: Hot and Dry First, Then Hot and Humid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Core Body Temperature | Core body temperature will be measured via a telemetric pill or rectal temperature probe. | Posted | Mean | Standard Deviation | degrees Celsius (°C) | Prior to and after the 3-hour simulated heat wave exposure. |
|
Adverse event data were collected from the first consent visit to the final experimental visit of the participant. This generally encompassed a 4-week time period for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Younger Participants: Hot and Dry | Individuals aged 18-39 years | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Craig Crandall | Institute for Exercise and Environmental Medicine | 214-345-4623 | craigcrandall@texashealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2024 | Jun 25, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
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| ID | Term |
|---|---|
| D006358 | Hot Temperature |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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| Hot and Dry Trial | Other | Individuals will be exposed to a simulated heat wave (hot and dry) condition. |
|
Heart rate will be measured via ECG electrodes attached to the participant
| At the end of the 3-hour simulated heat wave exposure. |
| Ending Mean Arterial Pressure | Arterial blood pressure will be measured using a standard arm blood pressure cuff. | At the end of the 3-hour simulated heat wave exposure. |
| Change in Cardiac Output | Cardiac output (how much blood is ejected from the heart per minute) was measured using echocardiography. | Prior to and after the 3-hour simulated heat wave exposure. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
Individuals aged 18-39 years that had the hot/dry trial first and the hot/humid trial second.
| BG002 | Older Participants: Hot and Humid First, Then Hot and Dry | Individuals aged 65 years or older that had the hot/humid trial first and the hot/dry trial second. |
| BG003 | Older Participants: Hot and Dry First, Then Hot and Humid | Individuals aged 65 years or older that had the hot/dry trial first and the hot/humid trial second. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Individuals aged 18-39 years.
| OG003 | Older Participants: Hot and Humid | Individuals aged 65 years or older. |
|
|
| Primary | Change in Peak Mitral Annular Systolic Velocity (S') | Change in peak mitral annular systolic velocity was measured by tissue doppler imaging. | Posted | Mean | Standard Deviation | cm/s | Prior to, during, and after each simulated heat wave exposure; approximately 20 min each |
|
|
|
| Secondary | Ending Skin Temperature | Skin temperature will be measured from small temperature sensitive electrodes attached to the participant's skin. | It should be noted that only 17 older participants for the hot/dry trial and 19 participants for the hot/humid trial were analyzed due to missing data/equipment issues. | Posted | Mean | Standard Deviation | degrees Celsius (°C) | At the end of the 3-hour simulated heat wave exposure. |
|
|
|
| Secondary | Ending Heart Rate | Heart rate will be measured via ECG electrodes attached to the participant | Posted | Mean | Standard Deviation | beats per minute (bpm) | At the end of the 3-hour simulated heat wave exposure. |
|
|
|
| Secondary | Ending Mean Arterial Pressure | Arterial blood pressure will be measured using a standard arm blood pressure cuff. | It should be noted that only 19 participants were analyzed in the Hot/Humid arm because of missing data/equipment issues. | Posted | Mean | Standard Deviation | mmHg | At the end of the 3-hour simulated heat wave exposure. |
|
|
|
| Secondary | Change in Cardiac Output | Cardiac output (how much blood is ejected from the heart per minute) was measured using echocardiography. | It should be known that only 16 participants in the hot/dry trials (younger and older) and the hot/humid trial (younger) and only 14 participants in the hot/humid trial (older) were analyzed due to missing data/equipment malfunction. | Posted | Mean | Standard Deviation | L/min | Prior to and after the 3-hour simulated heat wave exposure. |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Older Participants: Hot and Dry | Individuals aged 65 years or older | 0 | 21 | 0 | 21 | 0 | 21 |
| EG002 | Younger Participants: Hot and Humid | Individuals aged 18-39 years | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Older Participants: Hot and Humid | Individuals aged 65 years or older | 0 | 20 | 0 | 20 | 0 | 20 |
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| D014947 | Wounds and Injuries |
| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |