DepressionNCT06166095
Dose-Response Effect Exercise and Depression
A study testing high-dose and moderate-dose in people with Depression, run by University of Central Florida at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Depression
- What is being tested?
- high-dose and moderate-dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- diagnosis of a serious mental illness (SMI) such as schizophrenia or bipolar disorder
- pregnant or nursing
- current smoker
- beta-blocker medications
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Dose-Response Effect of Exercise on Depression and Brain-Derived Neurotrophic Factor (BDNF) in Sedentary Young Adults
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.
Read the 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:
- high-dose (HD) moderate to vigorous physical activity (MVPA) (n=16)
- moderate-dose (MD moderate to vigorous physical activity (MVPA) (n=16)
- a walking (W) attention control (n=16)
- Conditions
- Depression
- Being tested
- high-dose, Walking attention control, moderate-dose
- Keywords
- depression, exercise, BDNF, Brain-derived Neurotrophic Factor, Major Depressive Disorder, MDD
- Medical subject headings
- Depression, Motor Activity, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-doseOther
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 controlOther
The attention control group will be asked to wear the Fitbit activity tracker to monitor their sleep each night for 10 weeks.
moderate-doseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Walking attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Fitbit for heart rate
Heart rate (bpm.) will be collected through Fitabase from the Fitbit as the participants exercise and/ or walk.
Measured: 1 year
Fitbit for physical activity data
Duration of weekly physical activity (min.) data will be collected from the Fitbit activity trackers.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jul 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Sports Medicine
- Responsible party
- Sponsor
- Investigators
- A'Naja Newsome, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166095
- Sponsor's protocol ID
- STUDY00005112
- Status last verified
- Mar 2025
- First submitted
- 28 Sep 2023
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal information that is collected as part of this research will not be used or distributed for future research studies, even if all identifiers are removed.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Effect of Exercise on Depression and Brain-Derived Neurotrophic Factor (BDNF) in Sedentary Young Adults
- ClinicalTrials.gov ID
- NCT06166095
- Acronym / sponsor ID
- STUDY00005112
- Conditions
- Depression
- Keywords
- depression, exercise, BDNF, Brain-derived Neurotrophic Factor, Major Depressive Disorder, MDD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- American College of Sports Medicine
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- high-dose (HD) moderate to vigorous physical activity (MVPA) (n=16)
- moderate-dose (MD moderate to vigorous physical activity (MVPA) (n=16)
- a walking (W) attention control (n=16)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high-dose moderate to vigorous physical activity (MVPA) | Experimental | Other: high-doseParticipants 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. |
| moderate-dose moderate to vigorous physical activity (MVPA) | Experimental | Other: moderate-doseParticipants 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. |
| walking attention control | Experimental | Other: Walking attention controlParticipants 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-doseParticipants 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 | Other | high-dose moderate to vigorous physical activity (MVPA) |
| Walking attention controlThe attention control group will be asked to wear the Fitbit activity tracker to monitor their sleep each night for 10 weeks. | Other | walking attention control |
| moderate-doseParticipants 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 | Other | moderate-dose moderate to vigorous physical activity (MVPA) |
Primary outcome
Brain-derived Neurotrophic Factor (BDNF) assay
Time frame: 1 year
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
2 secondary outcomes
Fitbit for heart rate
Time frame: 1 year
Fitbit for physical activity data
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. Personal information that is collected as part of this research will not be used or distributed for future research studies, even if all identifiers are removed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A'Naja Newsome, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-dose and moderate-dose in people with Depression, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain-derived Neurotrophic Factor (BDNF) assay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.