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

NCT06629337 | Completed FDA Device

• 1 other identifier: 141-2324-EXP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prehypertension (elevated Blood Pressure) or Hypertension

Outcome Measures

Primary Outcomes (1)

• Post-exercise hypotension before and after the histamine blockade

  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

Study Arms (2)

Experimental: BFR exercise with histamine blockade

EXPERIMENTAL

Genetic: H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)

Sham Comparator: BFR exercise without histamine blockade

SHAM COMPARATOR

Genetic: H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)

Interventions

H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC) GENETIC

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

Experimental: BFR exercise with histamine blockade; Sham Comparator: BFR exercise without histamine blockade

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• hypertension
• muscular skeletal disorder

Sponsors & Collaborators

• California Baptist University: lead

Study Sites (1)

California Baptist University

Riverside, California, 92504, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension

Interventions

fexofenadine; Famotidine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: October 8, 2024
• Study Start: April 1, 2024
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-09

Locations

US (1)