Aerobic Exercise for Post-Exercise Hypotension

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Delaware

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for healthy young adults who are either not very active or exercise recreationally. They shouldn't have a history of heart problems, high blood pressure, metabolic or kidney diseases, respiratory issues, and must not be on any heart medications. Pregnant or breastfeeding individuals, tobacco users, those with certain musculoskeletal issues preventing cycling exercise, and people outside the BMI range of 18.5 to 35 are also excluded.

Inclusion Criteria

I am not very active or only exercise occasionally.

I am a healthy man or woman.

Exclusion Criteria

Current pregnancy or breastfeeding

You have an injury or condition that would make it hard for you to do cycling exercise.

I am currently taking erythromycin or ketoconazole.

Treatment Details

Interventions

• Moderate Intensity Aerobic Exercise (Behavioural Intervention)

Trial Overview The study tests how moderate aerobic exercise like stationary biking affects heart function and blood vessels in the legs by measuring changes before and after exercising. It looks at whether these changes result from decreased stiffness in large arteries or increased leg blood flow. Participants will take antihistamines during one visit and placebo pills during another to see the difference.

Participant Groups

Group I: Antihistamine Experimental Treatment 1 Intervention

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 II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

Harry Jiannan Wang

University of Delaware

Chief Executive Officer since 2023

PhD in Business Administration from Pennsylvania State University

Dr. Kenneth Gene Yancey

University of Delaware

Chief Medical Officer

MD from Harvard Medical School