HealthySHIFT-EXNCT07668622
Aerobic Exercise as a Countermeasure for Night Shift Associated Circadian Misalignment
A study testing Exercise in people with Healthy and Circadian Misalignment, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Healthy, Circadian Misalignment
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Justin Lorentzen, BHS, 303-724-3685, justin.lorentzen@cuanschutz.edu
Seth Creasy, PhD
About this study
Official title: The Impact of Exercise on Cardiometabolic Health During Shiftwork: A Proof of Concept Study
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).
Read the 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.
- Conditions
- Healthy, Circadian Misalignment
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in this arm will engage in simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with day time sleep. |
| Exercise | Experimental | Participants in this arm will engage in simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with day time sleep. In addition, participants will engage in a 45-minute bout of moderate intensity exercise at 2.5 hours after waking on days 3, 4, and 5. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 2 and 5
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.
Measured: Days 2 and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Creasy, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668622
- Sponsor's protocol ID
- 26-0127
- Acronym
- SHIFT-EX
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Exercise on Cardiometabolic Health During Shiftwork: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT07668622
- Acronym / sponsor ID
- SHIFT-EX / 26-0127
- Conditions
- Healthy, Circadian Misalignment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in this arm will engage in simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with day time sleep. |
| Exercise | Experimental | Behavioral: ExerciseParticipants in this arm will engage in simulated daytime work, with nighttime sleep, followed by 3 days of simulated night shift work, with day time sleep. In addition, participants will engage in a 45-minute bout of moderate intensity exercise at 2.5 hours after waking on days 3, 4, and 5. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseParticipants 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. | Behavioural | Exercise |
Primary outcome
24-hour ambulatory BP
Time frame: Days 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 Test
Time frame: Days 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seth Creasy, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Healthy and Circadian Misalignment, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Lorentzen, BHS (303-724-3685, justin.lorentzen@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour ambulatory BP (time frame: Days 2 and 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.