Dose-Response Effect Exercise and Depression

NCT06166095 | Completed

• 1 other identifier: STUDY00005112
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Fitbit for heart rate

  1 year

• Fitbit for physical activity data

  1 year

Study Arms (3)

high-dose moderate to vigorous physical activity (MVPA)

EXPERIMENTAL

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

moderate-dose moderate to vigorous physical activity (MVPA)

EXPERIMENTAL

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

walking attention control

EXPERIMENTAL

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

Interventions

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

high-dose moderate to vigorous physical activity (MVPA)

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.

walking attention control

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

moderate-dose moderate to vigorous physical activity (MVPA)

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead
• American College of Sports Medicine: collaborator

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Depression; Motor Activity; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• A'Naja Newsome, PhD

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: December 12, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)