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

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.

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

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.

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