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Completed

NCT Number: NCT06166095

Dose-Response Effect Exercise and Depression

The present study aims to address gaps in the literature by evaluating the objectively measured dose-response relationship between exercise and depression symptoms; examining changes in resting (Brain-derived Neurotrophic Factor) BDNF from baseline to week 10 of an exercise intervention; and assessing varying exercise intensities on enjoyment, affect, and health-related quality of life in sedentary young adult college students.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32816, United States

About this study

This 10-week randomized single-blind controlled trial will consist of an exercise intervention and attention control condition. A two-week familiarity trial period will be followed by 8 weeks of structured exercise. Objectively measured physical activity will be remotely monitored via Fitbit to examine its effect on depressive symptoms in sedentary young adult college students.

Approximately 48 enrolled college students ages 18 - 25 will be recruited for the proposed study and randomized with a 1:1:1 allocation to one of the following conditions:

  • high-dose (HD) moderate to vigorous physical activity (MVPA) (n=16)
  • moderate-dose (MD moderate to vigorous physical activity (MVPA) (n=16)
  • a walking (W) attention control (n=16)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • enrolled UCF college students aged 18 to 25
  • mild to moderate depressive symptoms
  • willing to wear a Fitbit for extended periods of time during the study
  • willing to participate in moderate-to-vigorous PA
  • physically able to participate in exercise safely

Exclusion criteria

  • under 110 lbs
  • history of bad reaction to a past blood draw
  • have been advised by a medical provider to not give/donate blood
  • presence of anemia
  • current cognitive therapy or antidepressant medication
  • diagnosis of a co-occurring condition such as attention deficit hyperactivity disorder (ADHD)
  • diagnosis of a serious mental illness (SMI) such as schizophrenia or bipolar disorder
  • pregnant or nursing
  • current smoker
  • beta-blocker medications

Treatment and study plan

high-dose

Other

Participants will be asked to perform a high-dose (HD) (i.e., 300 minutes of MVPA per week) of structured exercise for 10 weeks. Exercise modality and schedule will be participant- selected and may consist of any combination of aerobic and strength training that elevates the heart rate between 64 - 95 percent of estimated heart rate max

Walking attention control

Other

The attention control group will be asked to wear the Fitbit activity tracker to monitor their sleep each night for 10 weeks.

moderate-dose

Other

Participants will be asked to perform a moderate-dose (MD) (i.e., 150 minutes of MVPA per week) of structured exercise for 10 weeks. Exercise modality and schedule will be participant- selected and may consist of any combination of aerobic and strength training that elevates the heart rate between 64 - 95 percent of estimated heart rate max

Primary outcomes

  1. Brain-derived Neurotrophic Factor (BDNF) assay

    Time frame: 1 year

    A fasted (> 8 hours) blood draw will be performed at baseline and post-treatment to measure resting serum BDNF levels. Serum concentrations of total BDNF will be measured with Human BDNF Human ELISA assay kits for total serum BDNF from ThermoFisher Scientific

Secondary outcomes

  1. Fitbit for heart rate

    Time frame: 1 year

    Heart rate (bpm.) will be collected through Fitabase from the Fitbit as the participants exercise and/ or walk.

  2. Fitbit for physical activity data

    Time frame: 1 year

    Duration of weekly physical activity (min.) data will be collected from the Fitbit activity trackers.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Collaborators

  • American College of Sports Medicine

Registry information

Official study title

Dose-Response Effect of Exercise on Depression and Brain-Derived Neurotrophic Factor (BDNF) in Sedentary Young Adults

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2023
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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