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

NCT05097352 | Completed

• 1 other identifier: PROJECT00004322
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Traumatic Stress Disorder; Post Traumatic Stress Disorder; Trauma and Stressor Related Disorders; Mental Disorders; Exercise

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

High Intensity Interval Training (HIIT)

EXPERIMENTAL

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

Behavioral: High Intensity Interval Training (HIIT)

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.

Other: Waitlist

Interventions

High Intensity Interval Training (HIIT) BEHAVIORAL

Twenty minutes of HIIT will be completed three days a week for six weeks.

High Intensity Interval Training (HIIT)

Waitlist OTHER

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

Waitlist Control

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Georgia: lead

Study Sites (1)

University of Georgia

Athens, Georgia, 30605, United States

Location

Related Publications (1)

• McGranahan MJ, O'Connor PJ. Effect of high-intensity interval training exercise on sleep quality in women with probable post-traumatic stress disorder: A pilot randomized controlled trial. Sleep Med. 2025 May;129:245-256. doi: 10.1016/j.sleep.2025.02.029. Epub 2025 Feb 21.

  PMID: 40056660 DERIVED

MeSH Terms

Conditions

Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Motor Activity

Interventions

High-Intensity Interval Training; Waiting Lists

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Patrick J O'Connor, PhD

  University of Georgia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 28, 2021
• Study Start: January 24, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)