Clinical trial NCT06166095: Dose-Response Effect Exercise and Depression
Official title: Dose-Response Effect of Exercise on Depression and Brain-Derived Neurotrophic Factor (BDNF) in Sedentary Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: depression
exercise
BDNF
Brain-derived Neurotrophic Factor
Major Depressive Disorder
MDD
Lead sponsor: University of Central Florida
Sponsor class: OTHER
Collaborators: name: American College of Sports Medicine
First posted: 2023-12-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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)

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

Primary outcomes:
measure: Brain-derived Neurotrophic Factor (BDNF) assay
timeFrame: 1 year
Secondary outcomes:
measure: Fitbit for heart rate
timeFrame: 1 year
measure: Fitbit for physical activity data
timeFrame: 1 year
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: A'Naja Newsome, PhD
role: PRINCIPAL_INVESTIGATOR
References: