Dose-Response Effect Exercise and Depression

NCT ID: NCT06166095

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-01

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)

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

high-dose

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

moderate-dose

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Walking attention control

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American College of Sports Medicine

OTHER

Sponsor Role: collaborator

University of Central Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

A'Naja Newsome, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

University of Central Florida

Orlando, Florida, United States

Countries

United States

Other Identifiers

STUDY00005112

Identifier Type: -

Identifier Source: org_study_id