Dose-Response Effect Exercise and Depression

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Other: high-dose; Other: moderate-dose; Other: Walking attention control

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)

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amoy Fraser, PhD, CCRP, PMP; Phone Number: 4072668742; Email: amoy.fraser@ucf.edu
• Study Contact Backup: Name: Erica Martin, B.S.; Phone Number: 4072668742; Email: erica.martin@ucf.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • Recruiting
      • University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-dose moderate to vigorous physical activity (MVPA); 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; 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
Experimental: moderate-dose moderate to vigorous physical activity (MVPA); 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; 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
Experimental: walking attention control; 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; The attention control group will be asked to wear the Fitbit activity tracker to monitor their sleep each night for 10 weeks.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Central Florida
• Collaborators: American College of Sports Medicine
• Investigators: Principal Investigator: A'Naja Newsome, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: exercise; depression; MDD; Major Depressive Disorder; BDNF; Brain-derived Neurotrophic Factor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: STUDY00005112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Personal information that is collected as part of this research will not be used or distributed for future research studies, even if all identifiers are removed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No