Dose-Response Effect Exercise and Depression

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Depression

Intervention / Treatment
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* Other: high-dose
* Other: Walking attention control
* Other: moderate-dose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high-dose moderate to vigorous physical activity (MVPA)<br>Participants will be asked to perform a high-dose (HD) (i.e., 300 minutes of moderate to vigorous physical activity (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. Participants will be asked to track their activity using Fitbit. | Other: high-dose<br>* 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<br>|
| Experimental: moderate-dose moderate to vigorous physical activity (MVPA)<br>Participants will be asked to perform a moderate-dose (MD) (i.e., 150 minutes of moderate to vigorous physical activity (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. Participants will be asked to track their activity using Fitbit. | Other: moderate-dose<br>* 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<br>|
| Experimental: walking attention control<br>Participants will be provided sleep education material and will be asked to perform 15 minutes of leisure walking three times per week. This exercise intensity does not meet the recommended volume of exercise necessary for health benefits. Instructing participants to walk will reduce the likelihood that participants will undertake a more vigorous exercise routine. Participants will be asked to track their sleep each night using Fitbit. | Other: Walking attention control<br>* The attention control group will be asked to wear the Fitbit activity tracker to monitor their sleep each night for 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain-derived Neurotrophic Factor (BDNF) assay | 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 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitbit for heart rate | Heart rate (bpm.) will be collected through Fitabase from the Fitbit as the participants exercise and/ or walk. | 1 year | 
| Fitbit for physical activity data | Duration of weekly physical activity (min.) data will be collected from the Fitbit activity trackers. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, exercise, BDNF, Brain-derived Neurotrophic Factor, Major Depressive Disorder, MDD