Prehypertension (elevated Blood Pressure) or HypertensionNCT06629337
Effect of Aerobic Exercise with Blood Flow Restriction on Post-exercise Hypotension in Young Adults: the Role of Histamine Receptors
A study testing H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC) in people with Prehypertension (elevated Blood Pressure) or Hypertension, run by California Baptist University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prehypertension (elevated Blood Pressure) or Hypertension
- What is being tested?
- H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- good health,
- nonsmokers
- those not taking medications that could affect cardiovascular function
Who cannot join
- hypertension
- muscular skeletal disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
California Baptist University
Riverside, California, 92504
About this study
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.
- Being tested
- H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC)
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental: BFR exercise with histamine blockade | Experimental | Not described Receives: Genetic: H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC) |
| Sham Comparator: BFR exercise without histamine blockade | Sham comparator | Not described Receives: Genetic: H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-exercise hypotension before and after the histamine blockade
Blood pressure change during 60 min (10 min interval) after BFR exercise
Measured: 10 min, 20 min, 30 min, 40 min, 50 min, and 60 min post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Apr 2024
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prehypertension (elevated Blood Pressure) or HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong-Kyung Kim, California Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629337
- Sponsor's protocol ID
- 141-2324-EXP
- Status last verified
- Sep 2024
- First submitted
- 27 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise with Blood Flow Restriction on Post-exercise Hypotension in Young Adults: the Role of Histamine Receptors
- ClinicalTrials.gov ID
- NCT06629337
- Acronym / sponsor ID
- 141-2324-EXP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- California Baptist UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- good health,
- nonsmokers
- those not taking medications that could affect cardiovascular function
Key exclusion criteria (2 listed)
- hypertension
- muscular skeletal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Genetic | Experimental: BFR exercise with histamine blockade, Sham Comparator: BFR exercise without histamine blockade |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H1 receptor blockade: 540 mg (Allegra), H2 receptor blockade: 40 mg (Pepcid AC) in people with Prehypertension (elevated Blood Pressure) or Hypertension, run by California Baptist University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.