Young AdultsXTIMENCT07049783
Examining the Circadian Timing Effects of the Hypotensive Response to Exercise
A study testing Exercise in people with Young Adults and Hypertension, run by Freda Patterson at 1 site in United States.
Trial summary
The goal of this study is to learn how exercise timing affects blood pressure in adults with elevated or high blood pressure. Exercise can influence the body's natural 24-hour rhythms, including blood pressure patterns. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Young Adults, Hypertension, Post-Exercise Hypotension
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2025to 1 Oct 2026
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-39 Years old
- Resting blood pressure greater than or equal to 120/80 mmHg or less than 140/90 mmHg
Who cannot join
- Diagnosis or history of chronic or autoimmune disease (i.e., cardiovascular, metabolic, renal, endocrine, cancer)
- Diagnosis or history of sleep disorder (i.e., obstructive sleep apnea, insomnia, restless leg syndrome)
- Alcohol or drug dependence
- Elevated risk for sleep disorders
- Elevated risk for clinical depression
- Normotensive (blood pressure less than 120/80 mmHg) or stage 2+ hypertension (blood pressure greater than or equal to 140/90 mmHg)
Show all 14Show fewer
- Body mass index less than 18.5 or greater than 35 kg/m2
- Self-reported use of sleep medications/supplements (e.g., melatonin)
- Self-reported use of medications influencing vascular physiology (e.g., antihypertensive medications, weight loss medications)
- Highly physically active (greater than or equal to 300 minutes moderate-to-vigorous physical activity per week)
- Currently pregnant or breastfeeding
- Current tobacco use (greater than or equal to 1 cigarette in the past month)
- Nighttime or rotating shift work within the last 3 months
- Contraindications to aerobic exercise
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to learn how exercise timing affects blood pressure in adults with elevated or high blood pressure. Exercise can influence the body's natural 24-hour rhythms, including blood pressure patterns. A single exercise session can lower blood pressure for up to 24 hours, but it is not fully understood how the time-of-day for exercise affects this response. The main question this study aims to answer is:
- When the same participant exercises at different times of day (morning, afternoon, or evening), how does this affect the participant's blood pressure over the next 24 hours?
Read more
Participants will:
- Undergo an in-lab assessment of individual biological rhythm that will indicate the clock-time for an individual's biological night
- Complete 3 supervised treadmill exercise sessions
- 1 in the biological morning (biological night + 10 hours)
- 1 in the biological afternoon (biological night + 15 hours)
- 1 in the biological evening (biological night + 20 hours)
- Complete a 24-hour blood pressure assessment before and after each exercise session
Read the detailed description
This fully counterbalanced, within-subject, randomized crossover trial will examine the time-of-day dependent hypotensive effect of exercise in adults aged 18-39 years with elevated blood pressure or stage 1 hypertension. To examine this, participants will complete an assessment of dim-light melatonin onset (DLMO), the gold standard assessment of individual circadian phase, which will be used to subsequently prescribe three exercise sessions in the morning (10 hours after DLMO), afternoon (15 hours after DLMO), and evening (20 hours after DLMO) with 24-hour blood pressure assessment before and after each exercise sessions.
- Being tested
- Exercise
- Keywords
- Young adults, Hypertension, Post-exercise hypotension, Circadian rhythm
- Medical subject headings
- Hypertension, Post-Exercise Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A single standardized, in-lab, 30-minute monitored treadmill exercise session
| Study group | Role | What they receive |
|---|---|---|
| Morning | Experimental | Exercise 10 hours after dim-light melatonin onset Receives: Behavioral: Exercise |
| Afternoon | Experimental | Exercise 15 hours after dim-light melatonin onset Receives: Behavioral: Exercise |
| Evening | Experimental | Exercise 20 hours after dim-light melatonin onset Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daytime systolic blood pressure
Change in average daytime systolic blood pressure (post-exercise - pre-exercise)
Measured: 24-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start22 Jul 2025
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Young AdultsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freda Patterson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Freda Patterson, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049783
- Sponsor's protocol ID
- 2324519-1
- Acronym
- XTIME
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Circadian Timing Effects of the Hypotensive Response to Exercise
- ClinicalTrials.gov ID
- NCT07049783
- Acronym / sponsor ID
- XTIME / 2324519-1
- Keywords
- Young adults, Hypertension, Post-exercise hypotension, Circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Freda PattersonUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 3 Jul 2025 (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 how exercise timing affects blood pressure in adults with elevated or high blood pressure. Exercise can influence the body's natural 24-hour rhythms, including blood pressure patterns. A single exercise session can lower blood pressure for up to 24 hours, but it is not fully understood how the time-of-day for exercise affects this response. The main question this study aims to answer is:
- When the same participant exercises at different times of day (morning, afternoon, or evening), how does this affect the participant's blood pressure over the next 24 hours?
Participants will:
- Undergo an in-lab assessment of individual biological rhythm that will indicate the clock-time for an individual's biological night
- Complete 3 supervised treadmill exercise sessions
- 1 in the biological morning (biological night + 10 hours)
- 1 in the biological afternoon (biological night + 15 hours)
- 1 in the biological evening (biological night + 20 hours)
- Complete a 24-hour blood pressure assessment before and after each exercise session
Detailed description
This fully counterbalanced, within-subject, randomized crossover trial will examine the time-of-day dependent hypotensive effect of exercise in adults aged 18-39 years with elevated blood pressure or stage 1 hypertension. To examine this, participants will complete an assessment of dim-light melatonin onset (DLMO), the gold standard assessment of individual circadian phase, which will be used to subsequently prescribe three exercise sessions in the morning (10 hours after DLMO), afternoon (15 hours after DLMO), and evening (20 hours after DLMO) with 24-hour blood pressure assessment before and after each exercise sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morning | Experimental | Behavioral: ExerciseExercise 10 hours after dim-light melatonin onset |
| Afternoon | Experimental | Behavioral: ExerciseExercise 15 hours after dim-light melatonin onset |
| Evening | Experimental | Behavioral: ExerciseExercise 20 hours after dim-light melatonin onset |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-39 Years old
- Resting blood pressure greater than or equal to 120/80 mmHg or less than 140/90 mmHg
Key exclusion criteria (14 listed)
- Diagnosis or history of chronic or autoimmune disease (i.e., cardiovascular, metabolic, renal, endocrine, cancer)
- Diagnosis or history of sleep disorder (i.e., obstructive sleep apnea, insomnia, restless leg syndrome)
- Alcohol or drug dependence
- Elevated risk for sleep disorders
- Elevated risk for clinical depression
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 |
|---|---|---|
| ExerciseA single standardized, in-lab, 30-minute monitored treadmill exercise session | Behavioural | Afternoon, Evening, Morning |
Primary outcome
Average daytime systolic blood pressure
Time frame: 24-hours
Change in average daytime systolic blood pressure (post-exercise - pre-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 22 Oct 2026.
- Individual participant dataSharing planned: No
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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 Exercise in people with Young Adults and Hypertension, run by Freda Patterson 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 14 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 22 Oct 2026. 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. 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?
Average daytime systolic blood pressure (time frame: 24-hours). 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 22 Oct 2026.