Examining the Circadian Timing Effects of the Hypotensive Response to Exercise

NCT07049783 | Recruiting

• 1 other identifier: 2324519-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Young adults; Hypertension; Post-exercise hypotension; Circadian rhythm

Outcome Measures

Primary Outcomes (1)

• Average daytime systolic blood pressure

  Change in average daytime systolic blood pressure (post-exercise - pre-exercise)

  24-hours

Study Arms (3)

Morning

EXPERIMENTAL

Exercise 10 hours after dim-light melatonin onset

Behavioral: Exercise

Afternoon

EXPERIMENTAL

Exercise 15 hours after dim-light melatonin onset

Behavioral: Exercise

Evening

EXPERIMENTAL

Exercise 20 hours after dim-light melatonin onset

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Afternoon; Evening; Morning

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Freda Patterson: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Post-Exercise Hypotension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Freda Patterson, PhD

CONTACT

302-831-6588; fredap@udel.edu

Thomas Keiser

CONTACT

302-831-6588; tkeiser@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)