Aerobic Exercise for Night Shift Circadian Misalignment
This study is looking at whether aerobic exercise can help people who work night shifts avoid health problems that happen when their body's natural sleep-wake cycle (circadian rhythm) is out of sync. Researchers want to see if exercise can protect the body from these issues. You might be able to join if you are between 18 and 40 years old, have a Body Mass Index (BMI) between 18.5 and less than 40, and are not very active physically. The study will measure your blood pressure and how your body handles a meal to see if exercise helps. The current status of this study is unclear, and it plans to enroll 16 participants.
- Study design
- This is an interventional study that plans to enroll 16 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will have a 5-day stay with simulated daytime work and nighttime sleep, followed by 3 days of simulated night shift work with daytime sleep. Food will be provided on specific days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood pressure and mixed meal tolerance will be measured at Days 2 and 5.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07668622
Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment
Not Yet Recruiting
NAAges 18–40InterventionalUniversity of Colorado, DenverInvestigator-initiated
~16 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:Exercise
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
24-hour ambulatory BP
Measured over Days 2 and 5
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesColorado1
Study leadership
- Seth Creasy, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
Exclusion
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.
Diastolic blood pressure \>100 mmHG, systolic blood pressure \>160 mmHG, or resting heart rate \>100 bpm as measured in duplicate on the screening visit after 5 minutes of rest in a seated position.
Diabetes (fasting glucose \>/=126 mg/dL or Hemoglobin A1C \>/=6.5%) as measured during the screening visit.
Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range as measured during the screening visit) or history of uncontrolled thyroid disorder. History of thyroid disease or current thyroid disease treated with a stable medication regimen for at least 6 months is acceptable.
Triglycerides \>400 mg/dL as measured on the screening visit.
LDL cholesterol \>200 mg/dL as measured on the screening visit.
Abnormal resting electrocardiogram (ECG) as measured on the screening visit: serious arrhythmias, including multifocal PVC's, frequent PVC's (defined as 10 or more per min), ventricular tachycardia (defined as runs of 3 or more successive PVC's), or sustained atrial tachyarrhythmia; 2nd or 3rd degree A-V block, QTc interval \> 480 msec or other significant conduction defects.
Presence or history of any metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to participate in exercise: CVD, peripheral vascular disease, cerebrovascular disease, significant cardiac arrhythmias or cardiac valve disease, diabetes, uncontrolled hyper- or hypothyroidism, uncontrolled hypertension, cancer (within the last 5 years, except skin cancer or other cancers considered cured with excellent prognosis), HIV infection, significant renal, musculoskeletal, neurologic, hematologic, or psychiatric disease.
Significant gastrointestinal disorders including: chronic malabsorptive conditions, peptic ulcer disease, Crohn's disease, Ulcerative Colitis, chronic diarrhea, or active gallbladder disease.
Significant pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
Symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism (e.g., appetite suppressants, lithium, stimulants, anti-psychotics, tricyclic antidepressants).
Regular use of systemic steroids (other than Oral Contraceptive Pills).
Regular use of obesity pharmacotherapeutic agents within the last 6 months.
Current alcohol or substance abuse.
Nicotine use (past 6 months).
Current severe depression or history of severe depression within the previous year, based on DSM-IV-TR criteria for Major Depressive Episode. Score \> 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) will require further assessment by the Study MD to determine if it is appropriate for the subject to participate
History of other significant psychiatric illness (e.g., psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to the study conditions.
Weight loss \>5% in past 3 months.
Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.
Primary sleep disorders including but not limited to insomnia, obstructive sleep apnea, periodic limb movements in sleep, restless leg syndrome.
Night-time shiftwork, rotating work, or other circadian disruptions and disorders (e.g., diagnosed delayed sleep-wake phase disorder).
Self-reported long (\>9.25h) or short sleep (\<7h) that would make adhering the exercise conditions difficult.
Regular use of prescription or over-the-counter medications known to affect sleep (e.g., benzodiazepines, doxepin, zolpidem, trazodone, diphenhydramine HCl, etc.).
Regular use of melatonin (\>/=2 days per week).
High consumption of caffeine (\>500 mg/d) or unwilling to abstain from caffeine consumption during run-in and in-patient protocol.
Planned travel \>1 time zone away 4 weeks prior to study start or at any time during study protocol.
What this trial measures
- 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 5
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.