Examining the Circadian Timing Effects of the Hypotensive Response to Exercise

NCT ID: NCT07049783

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-22
• Study Completion Date: 2026-09-30

Brief 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. 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.

Conditions

Young Adults; Hypertension; Post-Exercise Hypotension; Circadian Rhythm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Morning

Exercise 10 hours after dim-light melatonin onset

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

A single standardized, in-lab, 30-minute monitored treadmill exercise session

Afternoon

Exercise 15 hours after dim-light melatonin onset

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

A single standardized, in-lab, 30-minute monitored treadmill exercise session

Evening

Exercise 20 hours after dim-light melatonin onset

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

A single standardized, in-lab, 30-minute monitored treadmill exercise session

Interventions

Exercise

A single standardized, in-lab, 30-minute monitored treadmill exercise session

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Freda Patterson

OTHER

Sponsor Role: lead

Responsible Party

Freda Patterson

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Delaware

Newark, Delaware, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Freda Patterson, PhD

Role: CONTACT

fredap@udel.edu

302-831-6588

Thomas Keiser

Role: CONTACT

tkeiser@udel.edu

302-831-6588

Facility Contacts

Thomas Keiser

Role: primary

tkeiser@udel.edu

302-831-6588

Other Identifiers

2324519-1

Identifier Type: -

Identifier Source: org_study_id