Student Exercise and Sleep Timing Study - Part 2 (SiESTa 2)

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Sleep; Mood
• Intervention / Treatment: Behavioral: Morning Exercise

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 610-304-1363; Email: cc2250@kines.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Sleep Lab
      • Contact: Research Coordinator; Phone Number: 6103041363; Email: cc2250@kines.rutgers.edu
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • College Avenue Gym
      • Contact: Assistant Director of Operations; Phone Number: 848-932-8063; Email: samantha.plum@rutgers.edu
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Cook/Douglass Rec Center
      • Contact: Assistant Director of Operations; Phone Number: 848-932-8063; Email: samantha.plum@rutgers.edu
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Fitness Center
      • Contact: Assistant Director of Operations; Phone Number: 848-932-8063; Email: samantha.plum@rutgers.edu
    • Piscataway, New Jersey, United States, 08854
      • Recruiting
      • Livingston Rec Center
      • Contact: Assistant Director of Operations; Phone Number: 848-932-8063; Email: samantha.plum@rutgers.edu
    • Piscataway, New Jersey, United States, 08854
      • Recruiting
      • Werblin Rec Center
      • Contact: Assistant Director of Operations; Phone Number: 848-932-8063; Email: samantha.plum@rutgers.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Normal Exercise; This arm has no intervention. Participants will continue to exercise at their normal evening time (6pm-11pm).
Experimental: Morning Exercise; Participants will change their exercise times to the morning (6am-11am).	Behavioral: Morning Exercise; Exercise is changed from normal (6pm-11pm) exercise to morning (6am-11am) exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mood	Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves mood (positive affect, depression, anxiety, anger). This will be measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) short form questionnaires for anger, anxiety, depression, and positive affect. Each subsection has a separate score, with higher scores indicating higher levels of anger (scores range from 5-25), anxiety (scores range from 8-40), depression (scores range from 8-40), or positive affect (scores range from 15-75) for each subsection.	2 weeks
Stress	Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning improves stress levels. This will be measured using the Perceived Stress Scale published in the Journal of Health and Social Behavior in 1983. Higher scores indicate higher stress levels with scores ranging from 0 to 56.	2 weeks
Productivity	Determine if, compared to a control condition (maintaining usual schedule), shifting exercise from evening to morning increases productivity. This will be measured using a 5-item questionnaire with a 4-answer scale of poor to excellent (1-4, respectively). The items ask about overall productivity, class attendance, time management, memory, and ability to maintain attention. Higher scores indicate greater productivity with scores ranging from 5 to 20.	2 weeks

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Andrea Spaeth, PhD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 16, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 18, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Exercise
• Other Study ID Numbers: Pro2024000249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The only IDP sharing that may occur is to other vetted researchers, it will not be made available to all researchers.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No