Examining the Circadian Timing Effects of the Hypotensive Response to Exercise (XTIME)

August 12, 2025 updated by: Freda Patterson

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Freda Patterson, PhD
  • Phone Number: 302-831-6588
  • Email: fredap@udel.edu

Study Contact Backup

Study Locations

  • United States
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • University of Delaware
        • Contact:
        • Principal Investigator:
          • Freda Patterson, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18-39 Years old
  • Resting blood pressure greater than or equal to 120/80 mmHg or less than 140/90 mmHg

Exclusion Criteria:

  • 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)
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Morning
Exercise 10 hours after dim-light melatonin onset
Behavioral: Exercise
A single standardized, in-lab, 30-minute monitored treadmill exercise session
Experimental: Afternoon
Exercise 15 hours after dim-light melatonin onset
Behavioral: Exercise
A single standardized, in-lab, 30-minute monitored treadmill exercise session
Experimental: Evening
Exercise 20 hours after dim-light melatonin onset
Behavioral: Exercise
A single standardized, in-lab, 30-minute monitored treadmill exercise session

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average daytime systolic blood pressure
Time Frame: 24-hours
Change in average daytime systolic blood pressure (post-exercise - pre-exercise)
24-hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Freda Patterson

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2324519-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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