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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06336590
Other study ID # Pro2024000249
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 10, 2024
Est. completion date December 16, 2026

Study information

Verified date May 2024
Source Rutgers, The State University of New Jersey
Contact Research Coordinator
Phone 610-304-1363
Email cc2250@kines.rutgers.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 62
Est. completion date December 16, 2026
Est. primary completion date December 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 23 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States College Avenue Gym New Brunswick New Jersey
United States Cook/Douglass Rec Center New Brunswick New Jersey
United States Rutgers Fitness Center New Brunswick New Jersey
United States Rutgers Sleep Lab New Brunswick New Jersey
United States Livingston Rec Center Piscataway New Jersey
United States Werblin Rec Center Piscataway New Jersey

Sponsors (1)

Lead Sponsor Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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