NCT04538144

Brief Summary

The purpose of this study is to assess the cardiovascular responses of the elderly to heat wave conditions

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 7, 2025

Completed
Last Updated

October 23, 2025

Status Verified

October 1, 2025

Enrollment Period

2.1 years

First QC Date

August 28, 2020

Results QC Date

June 25, 2025

Last Update Submit

October 21, 2025

Conditions

Keywords

agingheat wavecardiovascular

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (4)

  • Ending Skin Temperature

    At the end of the 3-hour simulated heat wave exposure.

  • Ending Heart Rate

    At the end of the 3-hour simulated heat wave exposure.

  • Ending Mean Arterial Pressure

    At the end of the 3-hour simulated heat wave exposure.

  • Change in Cardiac Output

    Prior to and after the 3-hour simulated heat wave exposure.

Study Arms (4)

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.

Other: Hot and Humid TrialOther: Hot and Dry Trial

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.

Other: Hot and Humid TrialOther: Hot and Dry Trial

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.

Other: Hot and Humid TrialOther: Hot and Dry Trial

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.

Other: Hot and Humid TrialOther: Hot and Dry Trial

Interventions

Individuals will be exposed to a simulated heat wave (hot and humid) condition.

Older participants: Hot/Dry then Hot/HumidOlder participants: Hot/Humid then Hot/DryYounger participants: Hot/Dry then Hot/HumidYounger participants: Hot/Humid then Hot/Dry

Individuals will be exposed to a simulated heat wave (hot and dry) condition.

Older participants: Hot/Dry then Hot/HumidOlder participants: Hot/Humid then Hot/DryYounger participants: Hot/Dry then Hot/HumidYounger participants: Hot/Humid then Hot/Dry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male and female individuals
  • years or 65+ years of age
  • Free of any underlying moderate to serious medical conditions

You may not qualify if:

  • Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, uncontrolled hypertension, and uncontrolled hypercholesterolemia.
  • Taking of any medications (such as beta blockers and non-dihydropyridine calcium channel blockers) that have known influences on either cardiac function or sweating responses.
  • Abnormalities detected on routine screening.
  • Individuals who participate in a structured aerobic exercise training program at moderate to high intensities.
  • Current smokers, as well as individuals who regularly smoked within the past 3 years.
  • Body mass index of greater than 30 kg/m\^2
  • Pregnant individuals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Hyperthermia

Interventions

Hot Temperature

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Results Point of Contact

Title
Dr. Craig Crandall
Organization
Institute for Exercise and Environmental Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

January 19, 2021

Primary Completion

February 20, 2023

Study Completion

February 20, 2023

Last Updated

October 23, 2025

Results First Posted

August 7, 2025

Record last verified: 2025-10

Locations