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临床试验/NCT03934723
NCT03934723Unknown不适用

Do Antidepressant Medications Blunt Responses to Exercise Training in Overweight and Obese Individuals?

California State University, San Marcos2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
2
主要终点
Waist circumference

研究概览

简要总结

Nearly one out of ten US adults over the age of 18 currently takes antidepressant medication, which can also treat other conditions such as anxiety. Combining pharmaceutical treatment with exercise may yield even greater benefits than using drugs alone, and this is commonly prescribed for depression. However, little is known about the drug-exercise interactions and their influence on metabolic health. A common side effect of antidepressant use is weight gain, particularly abdominal (visceral) fat, which is highly detrimental to overall health. Exercise is a well-known counter to abdominal fat accumulation. The aim of the proposed study is to compare the efficacy of 6 weeks of exercise training to reduce abdominal fat in healthy overweight/obese adults either taking or not taking antidepressant medication. Twenty-four inactive overweight/obese, but otherwise healthy, adults will complete 6 weeks of an exercise training intervention consisting of three days of aerobic exercise training per week. Participants will either not be taking antidepressant medication or will have been on their medication for at least 1 year. The primary outcome will be abdominal fat determined by waist circumference and dual x-ray absorptiometry, which is considered one of the optimal methods for assessment of abdominal fat.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be English language speakers
  • Male or females between the ages of 18-
  • All genders and ethnicities.
  • Healthy as assessed by a health history questionnaire (no diagnosed physical diseases or conditions preventing participation in exercise).
  • Individuals on antidepressants will be recruited if they are consuming selective serotonin reuptake inhibitors (SSRIs) and selective serotonin and norepinephrine reuptake inhibitors (SNRIs) only. Participants will send prescription information after consent has been provided as part of the screening process, including the dose and frequency of medication.
  • A body mass index (BMI) of 25 or greater is required for inclusion.

排除标准

  • Inability to complete moderate-vigorous exercise.
  • Taking first generation antidepressant medications or other medications such as monoamine oxidase inhibitors (MAOI).
  • Other medications, such as medications for attention-deficit hyper-activity disorder or metabolism
  • Undiagnosed depression that may be unveiled during the screening process.

研究组 & 干预措施

Control

Active Comparator

This arm will consist of healthy overweight and obese individuals who are physically inactive and do not have clinically diagnosed depression or depression symptoms.

干预措施: Exercise (Behavioral)

Antidpressants

Experimental

This arm will consist of healthy overweight and obese adults who are physically inactive and who are diagnosed with clinical depression and have been taking antidepressant medications for at least 1 year.

干预措施: Exercise (Behavioral)

结局指标

主要结局

Waist circumference

时间窗: Change from baseline after 6 weeks.

Waist circumference is a proxy of VAT

Visceral adipose tissue (VAT)

时间窗: Change from baseline after 6 weeks.

VAT assessed by dual-energy X-ray absorptiometry (DXA)

次要结局

  • Physical activity(Change from baseline after 6 weeks.)
  • Dietary intake(Change from baseline after 6 weeks.)
  • Aerobic fitness(Change from baseline after 6 weeks.)
  • Blood lipid panel(Change from baseline after 6 weeks.)
  • Body mass(Change from baseline after 6 weeks.)
  • Blood pressure(Change from baseline after 6 weeks.)
  • Blood glucose(Change from baseline after 6 weeks.)
  • Fat mass(Change from baseline after 6 weeks.)
  • Lean mass(Change from baseline after 6 weeks.)
  • Depression symptoms(Change from baseline after 6 weeks.)

研究者

发起方
California State University, San Marcos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Schubert

Assistant Professor of Kinesiology

California State University, San Marcos

研究点 (2)

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