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临床试验/NCT04077645
NCT04077645已完成不适用

Examining the Association of Sun Salutations and Aerobic Exercise With Cognition Among Adults With Psychosocial Stress

University of Illinois at Urbana-Champaign2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2019年9月1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
71
试验地点
2
主要终点
N-back Task (Working Memory)

研究概览

简要总结

The purpose of this acute randomized control study is to assess the feasibility of a low-to-moderate intensity Yoga intervention (i.e. sun salutations), and examine its effect on cognitive functioning, compared to engaging in aerobic activity or seated rest. Participants will include individuals who are currently experiencing symptoms of psychosocial stress or general anxiety.

详细描述

Eligible participants will be randomized to one of three groups: 1. Sun salutations (Yoga), 2. Aerobic exercise (walking on a treadmill), 3. Seated rest (watching educational videos). Each activity will be 30 minutes in duration. Immediately before and after the 30 minute intervention, participants will undergo psychosocial and cognitive assessments. Prior to the intervention, participant's physical activity will be tracked for one week, via a consumer grade accelerometer.

Baseline and post-intervention testing will include a cognitive battery, psychosocial questionnaires, flexibility testing and physiological measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Anyone between the ages of 18-45 years
  • Anyone with a score of 3 or higher on the Generalized Anxiety Disorder symptom checklist of the Diagnostic and Statistical Manual
  • That is, anyone meeting 3 or more symptoms, on more days of the week than not, for the past 6 months:
  • Restlessness, feeling keyed up or on edge.
  • Being easily fatigued.
  • Difficulty concentrating or mind going blank.
  • Irritability.
  • Muscle tension.
  • Sleep disturbance (difficulty falling or staying asleep, or restless, unsatisfying sleep).
  • Ability to exercise at moderate to vigorous activity levels (defined as 50%-75% of the adjusted age-predicted maximum heart rate)
  • Access to a smartphone and willingness to allow research staff to install a mobile activity tracker application (and space to allow for installation)
  • Willingness to be randomized into one of three groups

排除标准

  • Anyone who is physically active (≥30 minutes, 2 or more times/week, for the last 3 months) and/or a regular practitioner of Yoga or mind-body activities (≥30 minutes, 2 or more times/week, for the last 3 months).
  • Anyone with serious chronic medical conditions that would preclude them from participating without a physician present, or anyone with a risk of seizure, or anyone having psychiatric and/or neurological disorders.
  • Anyone who does not consent to wearing the Fitbit, or does not have a smartphone that allows us to download an app on their phone.
  • Pregnant women.
  • Anyone incapable of performing the following movements at a moderate intensity- sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up.
  • Anyone with blood pressure of 200/105 or more, and anyone who scores 1 or more on the Physical Activity Readiness Questionnaire
  • Anyone refusing or unwilling to be randomized into either of the conditions.

结局指标

主要结局

N-back Task (Working Memory)

时间窗: Change from baseline performance on the n-back at 30 minutes

This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 1-back task, participants have to decide whether the stimulus matches the stimulus presented 1 earlier. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. Reaction time and accuracy of the response are recorded.

N-back Task (Working Memory)

时间窗: Change from baseline performance on the n-back at 30 minutes

This is a computerized task measuring the working memory domain of cognition. The task had 3 conditions, namely, 0-back, 1-back and 2-back. Participants are presented with a series of stimuli one after the other. They have to decide whether the stimulus currently presented is the same as the stimulus presented "n" items before. For the 1-back task, participants have to decide whether the stimulus matches the stimulus presented 1 earlier. For the 2- back task, they have to decide whether the stimulus matches the stimulus presented 2 earlier. Reaction time and accuracy of the response are recorded.

次要结局

  • Visual Analog Scale for Stress(Change from baseline performance at 30 minutes)
  • Perceived Mental Fatigue(Change from baseline performance at 30 minutes)
  • Focus of Attention(Day 1)
  • Feeling Scale(Change from baseline performance at 30 minutes)
  • Heart Rate(Change from baseline performance at 30 minutes)
  • Rating of Perceived Exertion(Day 1)
  • Rating of Enjoyment and Intervention(Day 1)
  • Rating of Technology Ease of Use and Usability(Day 1)
  • Trail Making Test A and B (Global Cognition)(Change from baseline performance at 30 minutes)
  • Trail Making Test A and B (Global Cognition)(Change from baseline performance at 30 minutes)
  • Digit Symbol Substitution Test (Processing Speed)(Change from baseline performance at 30 minutes)
  • State Trait Anxiety Questionnaire(Change from baseline performance at 30 minutes)
  • Visual Analog Scale for Stress(Change from baseline performance at 30 minutes)
  • Perceived Mental Fatigue(Change from baseline performance at 30 minutes)
  • Focus of Attention(Day 1)
  • Feeling Scale(Change from baseline performance at 30 minutes)
  • Heart Rate(Change from baseline performance at 30 minutes)
  • Rating of Perceived Exertion(Day 1)
  • Rating of Enjoyment and Intervention(Day 1)
  • Rating of Technology Ease of Use and Usability(Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sean Mullen, PhD

Associate Professor

University of Illinois at Urbana-Champaign

研究点 (2)

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