Determinants of Changes in Arterial Load Following Exercise

NCT ID: NCT05820243

Last Updated: 2023-11-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-12
• Study Completion Date: 2024-09-30

Brief Summary

The goal of this study is to learn about how blood vessel dilation after exercise effects pulse wave reflection and influences the function of the heart in healthy young adults. The main question it aims to answer is: Are post-exercise decreases in reflected pulse waves due to a decrease in the stiffness of large arteries in the leg or an increase in leg blood flow? Participants will exercise on a stationary bicycle at a moderate intensity for 1 hour during two laboratory visits. Participants will take oral antihistamines to block post-exercise dilation at one visit, and they will take placebo pills at the other visit. At both visits, leg blood flow, pulse wave velocity, and heart function will be measured before exercise and for 120-minutes after exercise.

Detailed Description

During exercise, blood vessels increase in size to supply muscles with more blood. After exercise, the muscles that had been used release chemicals called histamines that cause the blood vessels to stay dilated even when the muscles no longer need more blood. It takes around 2 hours for the blood vessels to return to normal. This causes blood pressure to be lower than it usually is at rest. This phenomenon delays the return of pressure waves in arteries that are reflected back to the heart resulting in the heart having to work less hard to pump out blood for about 2 hours after exercise. However, it is unknown why the reflected pressure waves return to the heart later. The aim of this study is to determine if this delay is due to the speed of the reflected waves being slowed by large arteries or dilation of small arteries resulting in the reflections originating further from the heart. By giving antihistamines prior to exercise, post-exercise blood vessel dilation of the small arteries will be largely reduced, thus allowing for the determination of which factor causes the reflected waves to return later. Additionally, it is hypothesized that the reduction in work that the heart must perform results in improved contraction and relaxation of the heart. Thus, an additional aim is to determine how post-exercise blood vessel dilation influence heart function.

To accomplish these aims, blood flow leaving the left ventricle and femoral blood flow will be measured via Doppler ultrasound. Applanation tonometry will be used to record pulse waves at the carotid, radial, femoral, and dorsalis pedis arteries. These pulse waves will be used to estimate central blood pressure and to determine pulse wave velocity of different arterial segments. Measurements will be made at baseline and for 120 minutes after a bout of moderate intensity aerobic exercise.

Conditions

Post-Exercise Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Antihistamine

The oral antihistamine condition will consist of fexofenadine (540mg) and famotidine (40mg). Commercially available pills (3 x 180mg fexofenadine and 2 x 20mg famotidine) will be placed within opaque capsules and administered to the participants upon arrival to the laboratory.

Group Type: EXPERIMENTAL

Moderate Intensity Aerobic Exercise

Intervention Type: OTHER

Participants will complete 1 hour of exercise on a cycle ergometer at the power output that elicits 60% of their peak rate of oxygen consumption (V02peak).

Placebo

The placebo condition will consist of dextrose in an identical number of opaque capsules as the antihistamine treatment. Total dextrose will be \<5g. The capsules will be administered to the participants upon arrival to the laboratory.

Group Type: PLACEBO_COMPARATOR

Moderate Intensity Aerobic Exercise

Intervention Type: OTHER

Participants will complete 1 hour of exercise on a cycle ergometer at the power output that elicits 60% of their peak rate of oxygen consumption (V02peak).

Interventions

Moderate Intensity Aerobic Exercise

Participants will complete 1 hour of exercise on a cycle ergometer at the power output that elicits 60% of their peak rate of oxygen consumption (V02peak).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy men and women
• sedentary or recreationally active

Exclusion Criteria

• history of cardiovascular events or procedures
• stage 2 hypertension (BP: ≥140 systolic or ≥90 diastolic)
• metabolic syndrome
• renal disease
• chronic respiratory disease
• currently prescribed any cardiovascular medication
• current use of erythromycin and/ ketoconazole
• current pregnancy or breastfeeding -hormone replacement therapy-
• tobacco use
• musculoskeletal injury/disorder that would inhibit cycling exercise
• body mass index (BMI) <18.5 or >35kg/m^2
• reduced kidney function (estimated glomerular filtration rate< 90ml/min/1.73 m^2)
• daily use of fexofenadine and/or famotidine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

David Edwards

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Edwards, PhD

Role: CONTACT

dge@udel.edu

302-831-3363

Jordan Patik, PhD

Role: CONTACT

jpatik@udel.edu

5128206387

Facility Contacts

David Edwards, PhD

Role: primary

dge@udel.edu

Jordan Patik, PhD

Role: backup

jpatik@udel.edu

Other Identifiers

1783804

Identifier Type: -

Identifier Source: org_study_id