Heat Waves and the Elderly With COPD

Aging Clinical Trial

Official title:

Heat Waves and the Elderly With COPD: Reducing Thermal and Cardiovascular Consequences

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06295523
• Other study ID #: STU_2019_1759_COPD
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Whitley Atkins, PhD
• Phone: 214-345-4729
• Email: whitleyatkins[@]texashealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

Description:

Heat waves are the leading cause of death among natural disasters in the United States.

Elderly individuals are disproportionately more likely to become ill or die during heat waves. While the elderly have a reduced ability to regulate their body temperature,8-10 hospitalizations and deaths in this population during heat waves are primarily due to cardiovascular and/or respiratory complications, not solely hyperthermia. While previous research has primarily focused on the thermal and cardiovascular consequences of healthy aging, very little research has focused on the physiological responses to heat exposure in older individuals with chronic disease, such as chronic obstructive pulmonary disease (COPD). Notably, epidemiological data suggests that pulmonary complications are a leading cause of heat wave-related hospitalizations in older adults with a diagnosis of COPD, yet nothing is known regarding the physiological mechanisms by which those with COPD are most susceptible to heat waves. To fill this important gap, the investigators will identify the physiological responses that occur in this population, relative to healthy age-matched individuals, during two unique heat wave simulations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 years old or older

• Diagnosis of COPD

Exclusion Criteria:

• 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

• Participant with a body mass index =31 kg/m2

Related Conditions & MeSH terms

• Aging
• COPD
• Hyperthermia

Intervention

Other:
• Water Spray
Participants will receive water spraying on their body throughout the climate chamber exposure.
• Control
Participants will NOT receive water spraying on their body throughout the climate exposure.

Locations

Country	Name	City	State
United States	Texas Health Presbyterian Hospital Dallas	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core body temperature	Core body temperature will be measure from gastrointestinal temperature via an ingestible telemetric pill	Prior to and throughout each simulated heat wave exposure, an average of 480 minutes
Primary	Forced expiratory volume (FEV1)	FEV1 will be assessed via spirometry	Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
Primary	Forced vital capacity (FVC)	FVC will be assessed via spirometry	Prior to, during, and after each simulated heat wave exposure, approximately 10 min each
Primary	FEV1/FVC ratio	The ratio of forced expiratory volume and forced vital capacity will be assessed via spirometry	Prior to, during, and after each simulated heat wave exposure, approximately 10 min each