NCT04097886

Brief 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. Change in circadian phase was compared between the morning and evening group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
Last Updated

September 20, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

August 29, 2019

Last Update Submit

September 19, 2019

Conditions

Keywords

circadianphase shiftexercise

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline and following completion of exercise intervention (approximately 5 days)

Study Arms (2)

Morning Exercise Group

EXPERIMENTAL

Participants perform moderate exercise in the morning.

Other: Morning Exercise

Evening Exercise Group

EXPERIMENTAL

Participants perform moderate exercise in the evening.

Other: Evening Exercise

Interventions

moderate intensity exercise (70% VO2 max) each morning for 5 days

Morning Exercise Group

moderate intensity exercise (70% VO2 max) each evening for 5 days

Evening Exercise Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18.5-40.0
  • sedentary; \<=2 hrs structured exercise weekly
  • medication free (other than birth control)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Julie Pendergast

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 29, 2019

First Posted

September 20, 2019

Study Start

June 27, 2017

Primary Completion

March 9, 2019

Study Completion

March 9, 2019

Last Updated

September 20, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations