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Dose-Response Effect Exercise and Depression

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University of Central Florida

Status

Completed

Conditions

Depression

Treatments

Other: Walking attention control
Other: moderate-dose
Other: high-dose

Study type

Interventional

Funder types

Other

Identifiers

NCT06166095
STUDY00005112

Details and patient eligibility

About

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.

Full 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)

Enrollment

48 patients

Sex

All

Ages

18 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 3 patient groups

high-dose moderate to vigorous physical activity (MVPA)
Experimental group
Description:
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.
Treatment:
Other: high-dose
moderate-dose moderate to vigorous physical activity (MVPA)
Experimental group
Description:
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.
Treatment:
Other: moderate-dose
walking attention control
Experimental group
Description:
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.
Treatment:
Other: Walking attention control

Trial contacts and locations

1

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Central trial contact

Erica Martin, B.S.; Amoy Fraser, PhD, CCRP, PMP

Data sourced from clinicaltrials.gov

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