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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 Georgia1 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Pittsburg Sleep Quality Index (PSQI)

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
否

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

研究组 & 干预措施

High Intensity Interval Training (HIIT)

Experimental

High-intensity interval training will be performed three times a week for a total of six weeks.

干预措施: High Intensity Interval Training (HIIT) (Behavioral)

Waitlist Control

Sham Comparator

Waitlist participants were tested on the outcomes at the same time points as the treatment group (i.e., HIIT). Following completion of the waitlist treatment, participants will be eligible to receive a supervised exercise program (no data will be collected). The waitlist participants formed a no-treatment control group.

干预措施: Waitlist (Other)

结局指标

主要结局

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.

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.

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 (1)

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