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Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment

The Impact of Exercise on Cardiometabolic Health During Shiftwork: A Proof of Concept Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07668622
Acronym
SHIFT-EX
Enrollment
16
Registered
2026-06-25
Start date
2026-07-01
Completion date
2028-07-01
Last updated
2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circadian Misalignment, Healthy

Brief summary

This study plans to learn more about whether exercise can help protect the body from health problems that happen when a person's sleep and daily schedule are out of sync with their natural body clock (circadian rhythm).

Detailed description

This study plans to learn more about whether exercise can help protect the body from health problems that happen when a person's sleep and daily schedule are out of sync with their natural body clock (circadian rhythm). Specifically, this study will help us understand whether exercise can help protect the body from health problems that happen when a person's sleep and daily schedule, due to night shift work, are out of sync with their natural body clock.

Interventions

BEHAVIORALExercise

Participants will engage in a 5-day stay that includes simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with daytime sleep. On days 1, 3, and 4, participants will be provided food to eat (Day 1 +/- 1 hour:\~18:00 and \~23:00, Day 3 +/- 1 hour: \~08:30, \~13:00, \~18:00, \~23:00, and \~04:00. Day 4 +/-1 hour: \~18:00, \~23:00, \~04:00, and \~07:00). On days 2 and 5, participants will be provided with a diet to maintain your current weight (30% breakfast, 30% lunch, 30% dinner, 10% snack). On Day 2, participants will be provided a diet to be consumed at the following times: breakfast 08:30, lunch 13:00, dinner 18:00, snack 23:00. On Day 5, participants will follow a night shift schedule and meal timing that will follow the following schedule: breakfast 18:00, lunch 23:00, dinner 04:00, snack 07:00. Participants will engage in a 45-minute bout of moderate intensity aerobic exercise at 2.5 h after waking on days 3, 4, and 5.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Age 18-40 years * Body Mass Index 18.5-\<40kg/m\^2 * Physically inactive: defined as \<150 minutes per week of voluntary exercise at moderate intensity or greater and \<60 min per day of total habitual physical activity (i.e., work related, transportation related) at moderate intensity or greater, over the past 3 months. * No plans to relocate within the next 6 months. * No plans for extended travel (\>2 weeks) within the next 3 months. * Capable and willing to give informed consent, understand

Exclusion criteria

, and adhere to study conditions. * Have a primary care physician (or are willing to establish care with a primary care physician prior to study enrollment) to address medical issues which may arise during screening or study procedures. * No contraindications to exercise or limitations on ability to be physically active. * Ability to adhere to sleeping, eating, and exercise protocol * Willing and able to wear activity/sleep monitor for 7 consecutive days. * For Females: * Not currently pregnant or lactating. * Not pregnant within the past 6 months. * Not planning to become pregnant in the next 6 months * Regularly timed menstrual cycles to facilitate measurement of EE in the early follicular phase.

Design outcomes

Primary

MeasureTime frameDescription
24-hour ambulatory BPDays 2 and 5: During your WRIC visits on day 2 and day 5, a blood pressure cuff will be placed on your non-dominant arm to measure blood pressure every 30 minutes during the day and every 60 minutes at night.
Mixed Meal Tolerance TestDays 2 and 5On days 2 and 5, approximately 1 hour after waking up, you will have your blood drawn via an IV in your arm and will be given a liquid shake to consume. Over the course of 2 hours, regular, frequent blood samples will be collected through the IV over the duration of this test.

Countries

United States

Contacts

CONTACTJustin Lorentzen, BHS
justin.lorentzen@cuanschutz.edu303-724-3685
PRINCIPAL_INVESTIGATORSeth Creasy, PhD

University of Colorado, Denver

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026