Determinants of Changes in Arterial Load Following Exercise

Sponsor
University of Delaware (Other)
Overall Status
Recruiting
CT.gov ID
NCT05820243
Collaborator
(none)
25
1
2
17.1
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Moderate Intensity Aerobic Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
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.
Primary Purpose:
Basic Science
Official Title:
Determinants of Changes in Arterial Load Following Exercise
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Other: 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).

Placebo Comparator: 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.

Other: 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).

Outcome Measures

Primary Outcome Measures

  1. Change in lower limb arterial stiffness [120 minutes post-exercise]

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

  2. Change in leg vascular conductance [120 minutes post-exercise]

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

  3. Change in left ventricular pulsatile load [120 post-exercise]

    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.

Secondary Outcome Measures

  1. Change in left ventricular diastolic function [120 minutes post-exercise]

    Echocardiographic measures of left ventricular diastolic function will be recorded, including mitral annulus tissue velocity and mitral in-flow velocity

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Kinesiology and Applied Physiology, University of Delaware Newark Delaware United States 19713

Sponsors and Collaborators

  • University of Delaware

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Edwards, Professor, University of Delaware
ClinicalTrials.gov Identifier:
NCT05820243
Other Study ID Numbers:
  • 1783804
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Edwards, Professor, University of Delaware
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023