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CompletedNCT06629337Updated Oct 8, 2024

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

An interventional study of H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC) in Prehypertension (elevated Blood Pressure) or Hypertension, sponsored by California Baptist University. Completed at 1 site in United States. Open to male participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by California Baptist University · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Aug 2024, 2 years 1 month ago, and no results have been posted to the registry.
  • Registered 5 months after the study started (first participant enrolled Apr 2024, registered Sep 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Prehypertension (elevated Blood Pressure) or Hypertension
03

In context

Prehypertension

151 studies on the registry are indexed under Prehypertension; 22 are open to participants now.

This study's enrollment of 10 is below the median of 64 across 133 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

California Baptist University is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • hypertension
  • muscular skeletal disorder
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Experimental: BFR exercise with histamine blockade

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

  • Sham comparator
    Sham Comparator: BFR exercise without histamine blockade

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

Interventions

  • GeneticH1 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

06

What researchers measure

Primary outcomes

  1. Post-exercise hypotension before and after the histamine blockade

    Blood pressure change during 60 min (10 min interval) after BFR exercise

    Time frame: 10 min, 20 min, 30 min, 40 min, 50 min, and 60 min post exercise

07

Study locations

1 site
  • California Baptist University
    Riverside, California 92504, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2024 to primary completion in Aug 2024, 4 months.

Of 55 non-industry interventional studies with no phase under Prehypertension, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's 4 months is below that.

Counting every sponsor, half of 60 studies reached it within 20 months; a quarter within 11 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 27, 2024
First posted
Oct 8, 2024
StartActual
Apr 1, 2024
Primary completionActual
Aug 31, 2024
CompletionActual
Aug 31, 2024
Last update
Oct 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06629337
Lead sponsor
California Baptist University
Responsible party
Jong-Kyung Kim (Professor, California Baptist University) — Principal investigator
First posted
Oct 8, 2024
Start date
Apr 1, 2024
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024
Last update
Oct 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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