Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Colorado, Denver
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-40 years
Body Mass Index 18.5-<40kg/m²
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
BehavioralParticipants 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.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: ExerciseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
24-hour ambulatory BP
: 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.
Time frame
Days 2 and 52
Mixed Meal Tolerance Test
On 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.
Time frame
Days 2 and 5Sponsors and contacts
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Source ClinicalTrials.gov
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