Effects of a Short-term Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05097352
• Other study ID #: PROJECT00004322
• Status: Completed
• Phase: N/A
• Start date: January 24, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Disease
• Exercise
• Mental Disorders
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma and Stressor Related Disorders
• Traumatic Stress Disorder
• Wounds and Injuries

Intervention

Behavioral:
• High Intensity Interval Training (HIIT)
Twenty minutes of HIIT will be completed three days a week for six weeks.

Other:
• Waitlist
Waitlist participants will be tested on the outcomes at the same time points as the treatment group.

Locations

Country	Name	City	State
United States	University of Georgia	Athens	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburg Sleep Quality Index (PSQI)	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.	Change from Baseline to week 7
Primary	Heart Rate Variability	High frequency (HF) and low frequency (LF) domains of heart rate variability will be assessed before, during, and following a cognitive task.	Change from Baseline to Week 7
Primary	State Trait Anxiety Inventory (STAI-Y2)	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.	Change from Baseline to Week 7
Primary	The Posttraumatic Diagnostic Scale-5 (PDS-5)	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.	Change from Baseline to Week 7