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临床试验/NCT04847128
NCT04847128已完成不适用

The Effect of Exercise on Anxiety and Cognition in Students at University: A Randomized Controlled Trial

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
272
试验地点
1
主要终点
Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up

研究概览

简要总结

RATIONALE: Exercise may improve the mood and cognition in young people.

PURPOSE: It has been well-known that physical exercise can generally benefit the mental health. However, most evidences that physical exercise improves psychiatric symptoms come from retrospective or cross-sectional studies. Moreover, the studies on the effect of physical exercise in the young adults' mental health were limited. This randomized-controlled trial aims to determinate the effects of a chronic and aerobic exercise on the mood and cognition of young people.

详细描述

OBJECTIVES: The anxiety and depression symptoms in young people are worth paying attention to, in China and worldwide. Meanwhile, cognitive function is very important for young people's learning and work. This project aims to evaluate the effectiveness of the moderate aerobic exercise to alleviate anxiety and depression in young people.

DESIGN & METHODS: Undergraduate and graduate students aged 18-35 years will be randomly and evenly assigned to exercise and control groups. Subjects assigned to exercise group will receive an running exercise intervention more than 30 minutes and 3 times per week for 8 weeks. The control group will be advised not to engage in physical activities. Outcome measures include the score of the Self-rating Anxiety Scale (SAS), Self-rating Depression Scale (SDS), the response time of Schulte Grid test, and the response time of Stroop Colour-Word Test at baseline and post-intervention in two groups. In addition, these assessments will be followed up at week 20 (3 months after the end of intervention).

研究设计

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

盲法说明

The outcome assessors and statisticians were blinded to group allocations.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Undergraduate and graduate students aged 18 to 35 years.

排除标准

  • Heart disease, hypertension, cardiovascular and respiratory system diseases such as asthma and are unable to tolerate the frequency and strength of exercise requirements.
  • Any neurological or psychiatric disorders.
  • Physical disabilities.
  • Severe dysmenorrhea when they couldn't exercise more than 5 days before or after menstruation.
  • Color blindness.

结局指标

主要结局

Changes in the Self-rating Anxiety Scale (SAS) after intervention and at follow-up

时间窗: Change from baseline to post-intervention at week 8 and follow up (3 months after intervention)

The SAS is organized in 20 items, each with a score from 1 to 4, and a total score from 20 to 80. It will report the anxious mood, physical symptoms, psychomotor behavior and psychological symptoms of participants. Higher scores on the SAS indicate a higher level of anxiety symptoms.

次要结局

  • Changes in the response time of the Stroop Colour-Word Test after intervention and at follow-up(Change from baseline to post-intervention at week 8 and follow up (3 months after intervention))
  • Changes in the response times of Schulte Grid after intervention and at follow-up(Change from baseline to post-intervention at week 8 and follow up (3 months after intervention))
  • Changes in the Self-rating Depression Scale (SDS) after intervention and at follow-up(Change from baseline to post-intervention at week 8 and follow up (3 months after intervention))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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