Effect of Aerobic Exercise with Blood Flow Restriction on Post-exercise Hypotension in Young Adults: the Role of Histamine Receptors

October 3, 2024 updated by: Jong-Kyung Kim, California Baptist University
It was hypothesized that aerobic exercise with blood flow restriction (BFR) induced post exercise hypotension (PEH), and the reduction in blood pressure (BP) was due to peripheral vasodilation via the histamine receptors. Ten male participants participated in this study. The participants were randomly assigned to walk for 10 minutes at 6.4 k/m, 0% grade with or without BFR after taking histamine receptor blockade. Following exercise, BP was measured at 10 min interval for 60 minutes. Heart rate (HR), stroke volume (SV), cardiac output (CO), mean arterial pressure (MAP), and total peripheral resistance (TPR) were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Riverside, California, United States, 92504
        • California Baptist University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • good health,
  • nonsmokers
  • those not taking medications that could affect cardiovascular function

Exclusion Criteria:

  • hypertension
  • muscular skeletal disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: BFR exercise with histamine blockade
Genetic: H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)
Subjects ingested fexofenadine (540 mg, tablet) at least 50 minutes before and famotidine (40 mg, tablet) 1 hour 50 minutes before the onset of each protocol because these dose of oral fexofenadine and famotidine reaches its peak concentration at around 1 h and 2 h, respectively
Sham Comparator: Sham Comparator: BFR exercise without histamine blockade
Genetic: H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)
Subjects ingested fexofenadine (540 mg, tablet) at least 50 minutes before and famotidine (40 mg, tablet) 1 hour 50 minutes before the onset of each protocol because these dose of oral fexofenadine and famotidine reaches its peak concentration at around 1 h and 2 h, respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-exercise hypotension before and after the histamine blockade
Time Frame: 10 min, 20 min, 30 min, 40 min, 50 min, and 60 min post exercise
Blood pressure change during 60 min (10 min interval) after BFR exercise
10 min, 20 min, 30 min, 40 min, 50 min, and 60 min post exercise

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Baptist University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141-2324-EXP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prehypertension (elevated Blood Pressure) or Hypertension

Clinical Trials on H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)

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