Recruiting

Observational Study

Sponsor:

University of Delaware

Code:

NCT05820243

Conditions

Post-Exercise Hypotension

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Moderate Intensity Aerobic Exercise

Study Details

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

Study ID

NCT05820243

Start date

May 12, 2023

Status verified date

Nov, 2023

Completion date

Sep, 2024

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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).

Primary outcome measure

  • Change in lower limb arterial stiffness [ Time Frame: 120 minutes post-exercise ]
  • Change in leg vascular conductance [ Time Frame: 120 minutes post-exercise ]
  • Change in left ventricular pulsatile load [ Time Frame: 120 post-exercise ]

Central Contacts and Locations

Central contacts

David Edwards, PhD

302-831-3363dge@udel.edu

Jordan Patik, PhD

5128206387jpatik@udel.edu

Locations

Department of Kinesiology and Applied Physiology, University of Delaware

Recruiting

Newark, Delaware, United States, 19713

Contacts

David Edwards, PhD

dge@udel.edu

Jordan Patik, PhD

jpatik@udel.edu

Principal Investigator:

David Edwards, PhD

More Information

Sponsor

University of Delaware

Last update posted

Nov 28, 2023

Last verified

Nov, 2023

Keywords

  • arterial stiffness
  • wave reflections
  • pulsatile load

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Delaware on 2023-11-28.