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临床试验/NCT06166095
NCT06166095已完成不适用

Dose-Response Effect of Exercise on Depression and Brain-Derived Neurotrophic Factor (BDNF) in Sedentary Young Adults

University of Central Florida1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Brain-derived Neurotrophic Factor (BDNF) assay

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: high-dose (Other)

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.

干预措施: moderate-dose (Other)

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.

干预措施: Walking attention control (Other)

结局指标

主要结局

Brain-derived Neurotrophic Factor (BDNF) assay

时间窗: 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

次要结局

  • Fitbit for heart rate(1 year)
  • Fitbit for physical activity data(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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