NCT06336590

Brief Summary

The purpose of this study is to examine the effects of a morning exercise intervention on sleep (quality and duration), mood (positive affect, anxiety, depression, anger), stress and productivity among undergraduate students (18-23 years) evening-exercisers with poor self-reported sleep quality. Aim 1. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved sleep quality (increased efficiency, decreased fragmentation) and increased sleep duration. Aim 2. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit improved mood (increased positive affect, decreased depression, anxiety and anger). Aim 3. Compared to the control condition, evening-exercisers prescribed morning exercise will exhibit decreased stress and increased productivity.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress72%
Oct 2024Dec 2026

First Submitted

Initial submission to the registry

February 29, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2026

Last Updated

November 21, 2024

Status Verified

November 1, 2024

Enrollment Period

2.1 years

First QC Date

February 29, 2024

Last Update Submit

November 18, 2024

Conditions

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

  • Sleep Quality

    Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves sleep (quality and duration). Sleep quality includes variables such as the actigraph measured sleep period, total sleep time, sleep efficiency, and wake after sleep onset. Sleep quality and duration will be measured using wrist actigraphy, specifically the Phillips Actiwatch Spectrum Plus devices. The Epworth Sleepiness Scale will also be utilized to measure sleep quality, where scores range from 0-24 and higher scores signify more exhaustion and poorer sleep quality.

    2 weeks

Secondary Outcomes (3)

  • Mood

    2 weeks

  • Stress

    2 weeks

  • Productivity

    2 weeks

Study Arms (2)

Normal Exercise

NO INTERVENTION

This arm has no intervention. Participants will continue to exercise at their normal evening time (6pm-11pm).

Morning Exercise

EXPERIMENTAL

Participants will change their exercise times to the morning (6am-11am).

Behavioral: Morning Exercise

Interventions

Exercise is changed from normal (6pm-11pm) exercise to morning (6am-11am) exercise.

Morning Exercise

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy undergraduates (18-23 years)
  • Frequent evening exercisers (6pm-11pm, 3+ times per week)
  • Poor self-reported sleep quality
  • Must be willing to wear wrist actigraph 24/7 except when showering/bathing

You may not qualify if:

  • Sleep/circadian rhythm disorders
  • Medications for sleep
  • Inability to change schedule to exercise in AM
  • Inability to maintain exercise frequency over next 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

College Avenue Gym

New Brunswick, New Jersey, 08901, United States

RECRUITING

Cook/Douglass Rec Center

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Fitness Center

New Brunswick, New Jersey, 08901, United States

RECRUITING

Rutgers Sleep Lab

New Brunswick, New Jersey, 08901, United States

RECRUITING

Livingston Rec Center

Piscataway, New Jersey, 08854, United States

RECRUITING

Werblin Rec Center

Piscataway, New Jersey, 08854, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Andrea Spaeth, PhD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Coordinator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 29, 2024

Study Start

October 21, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 16, 2026

Last Updated

November 21, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

The only IDP sharing that may occur is to other vetted researchers, it will not be made available to all researchers.

Shared Documents
STUDY PROTOCOL
Time Frame
The deidentified data will be sent to vetted researchers who request it after the data collection period is complete. It will only be available for those vetted researchers for 6 years after the data collection period is complete.

Locations