Circadian Timing - ExerciseNCT04097886
Timed Exercise Study
A study testing Morning Exercise and Evening Exercise in people with Circadian Timing - Exercise, run by Julie Pendergast at 1 site in United States.
Trial summary
The purpose of this study was to investigate the effect of timed exercise on human circadian rhythms. Subjects were randomized to 5 days of morning or evening treadmill exercise. A measure of internal circadian timing, or phase, was measured at baseline and following the exercise intervention. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Circadian Timing - Exercise
- What is being tested?
- Morning Exercise and Evening Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 9 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.5-40.0
- sedentary; <=2 hrs structured exercise weekly
- medication free (other than birth control)
Who cannot join
- diagnosed conditions that would contraindicate safe participation in physical activity
- diagnosed psychiatric conditions
- night or rotating shift work 1-year prior to study
- travel across time zones within previous 4 weeks
- having children <2 years of age
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Timed Exercise on Human Circadian Rhythms
The purpose of this study was to investigate the effect of timed exercise on human circadian rhythms. Subjects were randomized to 5 days of morning or evening treadmill exercise. A measure of internal circadian timing, or phase, was measured at baseline and following the exercise intervention. Change in circadian phase was compared between the morning and evening group.
Read the detailed description
This study investigated the effect of morning versus evening exercise on internal circadian timing, or phase. Young, sedentary subjects were recruited for this study. Baseline measures included anthropometric, body composition, cardiorespiratory fitness, chronotype, and circadian phase. Subjects were randomized to 5 consecutive days of morning or evening exercise. Thirty minutes of exercise was performed at the designated time and intensity was maintained at a heart rate corresponding with 70% peak VO2. The measure of circadian phase was salivary dim light melatonin onset, indicated by the time when saliva melatonin concentration exceeded 4pg/ml. Post-exercise circadian phase was measured the evening following the last day of exercise. Changes in circadian phase were compared between morning and evening groups.
- Conditions
- Circadian Timing - Exercise
- Being tested
- Morning Exercise, Evening Exercise
- Keywords
- circadian, phase shift, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morning ExerciseOther
moderate intensity exercise (70% VO2 max) each morning for 5 days
Evening ExerciseOther
moderate intensity exercise (70% VO2 max) each evening for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Morning Exercise Group | Experimental | Participants perform moderate exercise in the morning. Receives: Other: Morning Exercise |
| Evening Exercise Group | Experimental | Participants perform moderate exercise in the evening. Receives: Other: Evening Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in onset (time) of melatonin secretion
Difference in onset (time at which salivary melatonin exceeds threshhold; 4pg/mL) from baseline to completion of exercise intervention.
Measured: baseline and following completion of exercise intervention (approximately 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start27 Jun 2017
- Primary completion9 Mar 2019
- Study completion9 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Circadian Timing - ExerciseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Pendergast
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julie Pendergast, University of Kentucky
- Investigators
- Julie Pendergast, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097886
- Sponsor's protocol ID
- 45342
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thomas JM, Kern PA, Bush HM, McQuerry KJ, Black WS, Clasey JL, Pendergast JS. Circadian rhythm phase shifts caused by timed exercise vary with chronotype. JCI Insight. 2020 Feb 13;5(3):e134270. doi: 10.1172/jci.insight.134270.
PubMed 31895695
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Timed Exercise on Human Circadian Rhythms
- ClinicalTrials.gov ID
- NCT04097886
- Acronym / sponsor ID
- 45342
- Conditions
- Circadian Timing - Exercise
- Keywords
- circadian, phase shift, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Julie PendergastUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 9 Mar 2019 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 20 Sep 2019 (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.
The purpose of this study was to investigate the effect of timed exercise on human circadian rhythms. Subjects were randomized to 5 days of morning or evening treadmill exercise. A measure of internal circadian timing, or phase, was measured at baseline and following the exercise intervention. Change in circadian phase was compared between the morning and evening group.
Detailed description
This study investigated the effect of morning versus evening exercise on internal circadian timing, or phase. Young, sedentary subjects were recruited for this study. Baseline measures included anthropometric, body composition, cardiorespiratory fitness, chronotype, and circadian phase. Subjects were randomized to 5 consecutive days of morning or evening exercise. Thirty minutes of exercise was performed at the designated time and intensity was maintained at a heart rate corresponding with 70% peak VO2. The measure of circadian phase was salivary dim light melatonin onset, indicated by the time when saliva melatonin concentration exceeded 4pg/ml. Post-exercise circadian phase was measured the evening following the last day of exercise. Changes in circadian phase were compared between morning and evening groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morning Exercise Group | Experimental | Other: Morning ExerciseParticipants perform moderate exercise in the morning. |
| Evening Exercise Group | Experimental | Other: Evening ExerciseParticipants perform moderate exercise in the evening. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18.5-40.0
- sedentary; <=2 hrs structured exercise weekly
- medication free (other than birth control)
Key exclusion criteria (6 listed)
- diagnosed conditions that would contraindicate safe participation in physical activity
- diagnosed psychiatric conditions
- night or rotating shift work 1-year prior to study
- travel across time zones within previous 4 weeks
- having children <2 years of age
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 |
|---|---|---|
| Morning Exercisemoderate intensity exercise (70% VO2 max) each morning for 5 days | Other | Morning Exercise Group |
| Evening Exercisemoderate intensity exercise (70% VO2 max) each evening for 5 days | Other | Evening Exercise Group |
Primary outcome
Change in onset (time) of melatonin secretion
Time frame: baseline and following completion of exercise intervention (approximately 5 days)
Difference in onset (time at which salivary melatonin exceeds threshhold; 4pg/mL) from baseline to completion of exercise intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Derived from this study: PubMed 31895695Thomas JM, Kern PA, Bush HM, McQuerry KJ, Black WS, Clasey JL, Pendergast JS. Circadian rhythm phase shifts caused by timed exercise vary with chronotype. JCI Insight. 2020 Feb 13;5(3):e134270. doi: 10.1172/jci.insight.134270.
- Individual participant dataSharing planned: No
Related trials for Circadian Timing - Exercise
Not yet recruiting
Chrono-restricted Diet and Physical Activity as a New Preventive Strategy for Sarcopenia in Postmenopausal Women With Obesity and Type 2 Diabetes
Obesity, Sarcopenia
Recruiting
The Acute T-Rex (Timing of Resistance Exercise) Study
Diabetes Mellitus, Type 2, Insulin Resistance
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. This study is not recruiting at the moment.
Julie Pendergast principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morning Exercise and Evening Exercise in people with Circadian Timing - Exercise, run by Julie Pendergast 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 20 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in onset (time) of melatonin secretion (time frame: baseline and following completion of exercise intervention (approximately 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04097886, which also lists 1 linked publication.
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 20 Sep 2019.