Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06166095
Other study ID # STUDY00005112
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date December 1, 2024

Study information

Verified date May 2024
Source University of Central Florida
Contact Amoy Fraser, PhD, CCRP, PMP
Phone 4072668742
Email amoy.fraser@ucf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 48
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.
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

Locations

Country Name City State
United States University of Central Florida Orlando Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Central Florida American College of Sports Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Fitbit for heart rate Heart rate (bpm.) will be collected through Fitabase from the Fitbit as the participants exercise and/ or walk. 1 year
Secondary Fitbit for physical activity data Duration of weekly physical activity (min.) data will be collected from the Fitbit activity trackers. 1 year
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05777044 - The Effect of Hatha Yoga on Mental Health N/A
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting NCT04977232 - Adjunctive Game Intervention for Anhedonia in MDD Patients N/A
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Completed NCT04512768 - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT04617015 - Defining and Treating Depression-related Asthma Early Phase 1
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed NCT04476446 - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives Phase 3
Recruiting NCT02783430 - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease Phase 2/Phase 3
Recruiting NCT05563805 - Exploring Virtual Reality Adventure Training Exergaming N/A
Completed NCT04598165 - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support N/A
Completed NCT03457714 - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting NCT05956912 - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed NCT05588622 - Meru Health Program for Cancer Patients With Depression and Anxiety N/A
Recruiting NCT05234476 - Behavioral Activation Plus Savoring for University Students N/A
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Enrolling by invitation NCT03276585 - Night in Japan Home Sleep Monitoring Study
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A