Determinants of Changes in Arterial Load Following Exercise

NCT05820243 | Unknown

• 1 other identifier: 1783804
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Exercise Hypotension

Keywords

arterial stiffness; wave reflections; pulsatile load

Outcome Measures

Primary Outcomes (3)

• Change in lower limb arterial stiffness

  Arterial stiffness of the leg will be assessed via measurement of femoral-pedis pulse wave velocity.

  120 minutes post-exercise

• Change in leg vascular conductance

  Vascular conductance, an index of peripheral vasodilation, will be determined by measuring femoral blood flow via ultrasound and dividing by mean arterial pressure.

  120 minutes post-exercise

• Change in left ventricular pulsatile load

  Doppler echocardiography and arterial tonometry will be used to establish left ventricular pressure-flow relations. Wave separation analysis will subsequently be performed to determine the magnitude and timing of reflected pulse waves.

  120 post-exercise

Secondary Outcomes (1)

• Change in left ventricular diastolic function

  120 minutes post-exercise

Study Arms (2)

Antihistamine

EXPERIMENTAL

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.

Other: Moderate Intensity Aerobic Exercise

Placebo

PLACEBO COMPARATOR

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.

Other: Moderate Intensity Aerobic Exercise

Interventions

Moderate Intensity Aerobic Exercise 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).

Antihistamine; Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy men and women
• sedentary or recreationally active

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

Department of Kinesiology and Applied Physiology, University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Conditions

Post-Exercise Hypotension

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

David Edwards, PhD

CONTACT

302-831-3363; dge@udel.edu

Jordan Patik, PhD

CONTACT

5128206387; jpatik@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Antihistamine and placebo treatments will be provided in opaque gel capsules by a member of the research team not involved in data collection or analysis.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 19, 2023
• Study Start: May 12, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Locations

US (1)