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Dose-Response Effect Exercise and Depression

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06166095
Enrollment
48
Registered
2023-12-12
Start date
2023-07-01
Completion date
2024-12-01
Last updated
2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

depression, exercise, BDNF, Brain-derived Neurotrophic Factor, Major Depressive Disorder, MDD

Brief summary

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.

Detailed description

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: 1. high-dose (HD) moderate to vigorous physical activity (MVPA) (n=16) 2. moderate-dose (MD moderate to vigorous physical activity (MVPA) (n=16) 3. a walking (W) attention control (n=16)

Interventions

OTHERWalking attention control

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

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

OTHERmoderate-dose

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

Sponsors

American College of Sports Medicine
CollaboratorOTHER
University of Central Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Brain-derived Neurotrophic Factor (BDNF) assay1 yearA 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

MeasureTime frameDescription
Fitbit for physical activity data1 yearDuration of weekly physical activity (min.) data will be collected from the Fitbit activity trackers.
Fitbit for heart rate1 yearHeart rate (bpm.) will be collected through Fitabase from the Fitbit as the participants exercise and/ or walk.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026