- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097886
Timed Exercise Study
September 19, 2019 updated by: Julie Pendergast
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI 18.5-40.0
- sedentary; <=2 hrs structured exercise weekly
- medication free (other than birth control)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Morning Exercise Group
Participants perform moderate exercise in the morning.
|
moderate intensity exercise (70% VO2 max) each morning for 5 days
|
Experimental: Evening Exercise Group
Participants perform moderate exercise in the evening.
|
moderate intensity exercise (70% VO2 max) each evening for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline and following completion of exercise intervention (approximately 5 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie Pendergast, University of Kentucky
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2017
Primary Completion (Actual)
March 9, 2019
Study Completion (Actual)
March 9, 2019
Study Registration Dates
First Submitted
August 29, 2019
First Submitted That Met QC Criteria
September 19, 2019
First Posted (Actual)
September 20, 2019
Study Record Updates
Last Update Posted (Actual)
September 20, 2019
Last Update Submitted That Met QC Criteria
September 19, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 45342
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Circadian Timing - Exercise
-
Paracelsus Medical UniversityTechnical University of MunichUnknownExercise | Circadian | TestosteroneGermany
-
Cairo UniversityCompletedDinoprostone TimingEgypt
-
Université de MontréalCanadian Institutes of Health Research (CIHR)Recruiting
-
Pennington Biomedical Research CenterThe Obesity SocietyCompleted
-
Universidad de GranadaCompletedGlucose Metabolism | Aerobic Exercise | Lipid Metabolism | Young Adults | Acute Exercise | Circadian Rhythm Sleep-Wake Disorders, Unspecified Type | Diurnal VariationSpain
-
Brigham and Women's HospitalRecruitingLight Exposure | Meal TimingUnited States
-
University of ArkansasCompletedFetal Exposure Timing UnspecifiedUnited States
-
The University of Tennessee, KnoxvilleUniversity of Tennessee Graduate School of MedicineRecruitingHyperglycemia | Physical Activity | Glucose Intolerance | Exercise | Circadian Rhythm | GDMUnited States
-
Inje UniversityCompletedThe Timing of Bowel Preparation in Outpatient ColonoscopyKorea, Republic of
-
Karadeniz Technical UniversityOnur Yilmaz; Pinar SivrikayaCompletedDental Anxiety | Timing in Dentist-Patient CommunicationTurkey
Clinical Trials on Morning Exercise
-
Rutgers, The State University of New JerseyNoom Inc.RecruitingDiabetes Mellitus, Type 2 | Metabolic SyndromeUnited States
-
University of AarhusNot yet recruiting
-
USDA Grand Forks Human Nutrition Research CenterRecruiting
-
Rutgers, The State University of New JerseyNot yet recruiting
-
University of Missouri-ColumbiaCompleted
-
RenJi HospitalNot yet recruitingST-segment Elevation Myocardial Infarction (STEMI)
-
University of AlbertaDexCom, Inc.CompletedType 1 DiabetesCanada
-
Nottingham Trent UniversityLoughborough UniversityCompleted
-
University of Colorado, DenverNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
The Miriam HospitalActive, not recruitingObesityUnited States