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临床试验/NCT05097352
NCT05097352已完成不适用

Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

University of Georgia2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年1月24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
41
试验地点
2
主要终点
Heart Rate Variability

研究概览

简要总结

This study aims to test whether sleep improvements, following 6 weeks of high-intensity interval training exercise among adult women exposed to a traumatic event, are mediated by improvements in heart rate variability or decreased anxiety and hyperarousal symptoms.

详细描述

A total of 60 women with below-average sleep quality and physical activity levels who also screen positive for PTSD on the Post-traumatic Diagnostic Scale (PDS-5) will be randomized to either six weeks of exercise training or a waitlist control. Twenty minutes of high intensity interval training will be performed three times per week for six-weeks. Heart rate variability will be measured at rest, during, and following a cognitive task. Psychometric measures supported by strong validity evidence will assess self-reported anxiety and PTSD symptoms, and sleep quality.

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
None

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • self-reported exposure to a traumatic event
  • persistent (> 1 month) PTSD-related symptoms adequate to screen positive for PTSD or self-reported history of a prior PTSD diagnosed by a health care professional.
  • poor sleep quality (Pittsburgh Sleep Quality Index >5)
  • failure to meet recommended level of aerobic or resistance training during leisure time. Physical activity for U.S. adults (<150-mins of moderate or 75-mins of vigorous physical activity [or a combination] per week and/or < 2 days a week of resistance training targeting the major muscle groups).
  • able to safely perform high-intensity exercise
  • aged 18-39 years
  • non-smoker
  • willing to avoid alcohol and vigorous physical activity 24 hours before visiting the lab
  • willing to avoid caffeine for 12 hours before visiting the lab

排除标准

  • Pregnant, lactating, or plans to become pregnant over the next 2 months.
  • Individuals who started taking medication for anxiety or depression-related symptoms within the last month.
  • Individuals currently taking beta-blockers or other medications/substances (marijuana and other illegal drugs) that impact heart rate.
  • History of reproductive disorders (e.g., premenstrual dysphoric disorder or polycystic ovary syndrome), cardiovascular (e.g., cardiac arrhythmia), or pulmonary disorders (e.g., asthma).
  • Pain intensity of 8 or greater in the thigh or foot in the past month
  • Probable alcohol use disorder

结局指标

主要结局

Heart Rate Variability

时间窗: Change from Baseline to Week 7

High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.

The Posttraumatic Diagnostic Scale-5 (PDS-5)

时间窗: Change from Baseline to Week 7

The PDS-5 consists 24-item scale and will assess PTSD symptoms based on the diagnostic criteria for the DMS-5. The full PDS-5 assesses trauma history, symptom onset, and index of trauma. The total score ranges from 0-80.

State Trait Anxiety Inventory (STAI-Y2)

时间窗: Change from Baseline to Week 7

The STAI-Y2 Trait subscale consists of 20-item and will assess anxiety. The total score ranges from 20-80; higher scores indicate greater trait anxiety.

Pittsburg Sleep Quality Index (PSQI)

时间窗: Change from Baseline to week 7

The PSQI consists of 19 items. Scores range from 0-21, higher scores indicate poorer sleep quality. A global score ≥5 indicates poor sleep quality.

次要结局

未报告次要终点

研究者

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

Patrick O'Connor

Professor

University of Georgia

研究点 (2)

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