Post-Exercise HypotensionNCT05820243
Determinants of Changes in Arterial Load Following Exercise
A study testing Moderate Intensity Aerobic Exercise in people with Post-Exercise Hypotension, run by University of Delaware at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Exercise Hypotension
- What is being tested?
- Moderate Intensity Aerobic Exercise
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to Sep 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
- sedentary or recreationally active
Who cannot join
- history of cardiovascular events or procedures
- stage 2 hypertension (BP: ≥140 systolic or ≥90 diastolic)
- metabolic syndrome
- renal disease
- chronic respiratory disease
- currently prescribed any cardiovascular medication
Show all 13Show fewer
- current use of erythromycin and/ ketoconazole
- current pregnancy or breastfeeding -hormone replacement therapy-
- tobacco use
- musculoskeletal injury/disorder that would inhibit cycling exercise
- body mass index (BMI) <18.5 or >35kg/m^2
- reduced kidney function (estimated glomerular filtration rate< 90ml/min/1.73 m^2)
- daily use of fexofenadine and/or famotidine
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Department of Kinesiology and Applied Physiology, University of Delaware
Newark, Delaware, 19713
David Edwards, PhD, dge@udel.edu
Jordan Patik, PhD, jpatik@udel.edu
About this study
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.
Read the detailed description
During exercise, blood vessels increase in size to supply muscles with more blood. After exercise, the muscles that had been used release chemicals called histamines that cause the blood vessels to stay dilated even when the muscles no longer need more blood. It takes around 2 hours for the blood vessels to return to normal. This causes blood pressure to be lower than it usually is at rest. This phenomenon delays the return of pressure waves in arteries that are reflected back to the heart resulting in the heart having to work less hard to pump out blood for about 2 hours after exercise. However, it is unknown why the reflected pressure waves return to the heart later. The aim of this study is to determine if this delay is due to the speed of the reflected waves being slowed by large arteries or dilation of small arteries resulting in the reflections originating further from the heart. By giving antihistamines prior to exercise, post-exercise blood vessel dilation of the small arteries will be largely reduced, thus allowing for the determination of which factor causes the reflected waves to return later. Additionally, it is hypothesized that the reduction in work that the heart must perform results in improved contraction and relaxation of the heart. Thus, an additional aim is to determine how post-exercise blood vessel dilation influence heart function.
To accomplish these aims, blood flow leaving the left ventricle and femoral blood flow will be measured via Doppler ultrasound. Applanation tonometry will be used to record pulse waves at the carotid, radial, femoral, and dorsalis pedis arteries. These pulse waves will be used to estimate central blood pressure and to determine pulse wave velocity of different arterial segments. Measurements will be made at baseline and for 120 minutes after a bout of moderate intensity aerobic exercise.
- Conditions
- Post-Exercise Hypotension
- Being tested
- Moderate Intensity Aerobic Exercise
- Keywords
- arterial stiffness, wave reflections, pulsatile load
- Medical subject headings
- Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate Intensity Aerobic ExerciseOther
Participants will complete 1 hour of exercise on a cycle ergometer at the power output that elicits 60% of their peak rate of oxygen consumption (V02peak).
| Study group | Role | What they receive |
|---|---|---|
| Antihistamine | Experimental | 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. Receives: Other: Moderate Intensity Aerobic Exercise |
| Placebo | Placebo comparator | 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. Receives: Other: Moderate Intensity Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb arterial stiffness
Arterial stiffness of the leg will be assessed via measurement of femoral-pedis pulse wave velocity.
Measured: 120 minutes post-exercise
Change in leg vascular conductance
Vascular conductance, an index of peripheral vasodilation, will be determined by measuring femoral blood flow via ultrasound and dividing by mean arterial pressure.
Measured: 120 minutes post-exercise
Change in left ventricular pulsatile load
Doppler echocardiography and arterial tonometry will be used to establish left ventricular pressure-flow relations. Wave separation analysis will subsequently be performed to determine the magnitude and timing of reflected pulse waves.
Measured: 120 post-exercise
Secondary outcomes (1)
Change in left ventricular diastolic function
Echocardiographic measures of left ventricular diastolic function will be recorded, including mitral annulus tissue velocity and mitral in-flow velocity
Measured: 120 minutes post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start12 May 2023
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Exercise HypotensionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Edwards, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820243
- Sponsor's protocol ID
- 1783804
- Status last verified
- Nov 2023
- First submitted
- 16 Mar 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Changes in Arterial Load Following Exercise
- ClinicalTrials.gov ID
- NCT05820243
- Acronym / sponsor ID
- 1783804
- Conditions
- Post-Exercise Hypotension
- Keywords
- arterial stiffness, wave reflections, pulsatile load
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 12 May 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Apr 2023 (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.
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.
Detailed description
During exercise, blood vessels increase in size to supply muscles with more blood. After exercise, the muscles that had been used release chemicals called histamines that cause the blood vessels to stay dilated even when the muscles no longer need more blood. It takes around 2 hours for the blood vessels to return to normal. This causes blood pressure to be lower than it usually is at rest. This phenomenon delays the return of pressure waves in arteries that are reflected back to the heart resulting in the heart having to work less hard to pump out blood for about 2 hours after exercise. However, it is unknown why the reflected pressure waves return to the heart later. The aim of this study is to determine if this delay is due to the speed of the reflected waves being slowed by large arteries or dilation of small arteries resulting in the reflections originating further from the heart. By giving antihistamines prior to exercise, post-exercise blood vessel dilation of the small arteries will be largely reduced, thus allowing for the determination of which factor causes the reflected waves to return later. Additionally, it is hypothesized that the reduction in work that the heart must perform results in improved contraction and relaxation of the heart. Thus, an additional aim is to determine how post-exercise blood vessel dilation influence heart function.
To accomplish these aims, blood flow leaving the left ventricle and femoral blood flow will be measured via Doppler ultrasound. Applanation tonometry will be used to record pulse waves at the carotid, radial, femoral, and dorsalis pedis arteries. These pulse waves will be used to estimate central blood pressure and to determine pulse wave velocity of different arterial segments. Measurements will be made at baseline and for 120 minutes after a bout of moderate intensity aerobic exercise.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antihistamine | Experimental | Other: Moderate Intensity Aerobic ExerciseThe 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. |
| Placebo | Placebo comparator | Other: Moderate Intensity Aerobic ExerciseThe 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 may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy men and women
- sedentary or recreationally active
Key exclusion criteria (13 listed)
- history of cardiovascular events or procedures
- stage 2 hypertension (BP: ≥140 systolic or ≥90 diastolic)
- metabolic syndrome
- renal disease
- chronic respiratory disease
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 |
|---|---|---|
| Moderate Intensity Aerobic ExerciseParticipants will complete 1 hour of exercise on a cycle ergometer at the power output that elicits 60% of their peak rate of oxygen consumption (V02peak). | Other | Antihistamine, Placebo |
Primary outcome
Change in lower limb arterial stiffness
Time frame: 120 minutes post-exercise
Arterial stiffness of the leg will be assessed via measurement of femoral-pedis pulse wave velocity.
Change in leg vascular conductance
Time frame: 120 minutes post-exercise
Vascular conductance, an index of peripheral vasodilation, will be determined by measuring femoral blood flow via ultrasound and dividing by mean arterial pressure.
Change in left ventricular pulsatile load
Time frame: 120 post-exercise
Doppler echocardiography and arterial tonometry will be used to establish left ventricular pressure-flow relations. Wave separation analysis will subsequently be performed to determine the magnitude and timing of reflected pulse waves.
1 secondary outcome
Change in left ventricular diastolic function
Time frame: 120 minutes post-exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate Intensity Aerobic Exercise in people with Post-Exercise Hypotension, run by University of Delaware 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 2 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Edwards, PhD (302-831-3363, dge@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower limb arterial stiffness (time frame: 120 minutes post-exercise). The study lists 3 primary outcomes in all. 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 28 Nov 2023.