Effects of a High-intensity Interval Training (HIIT) Exercise Intervention on Sleep in Women Exposed to Trauma: A Randomized Controlled Trial
Sponsor study identifier
interventional
41
1 country
1
Study Start
January 24, 2022
Actual (reported)Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 28, 2021
Actual (reported)October 28, 2021
Actual (reported)January 24, 2022
Actual (reported)March 31, 2023
Actual (reported)March 31, 2023
Actual (reported)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
High-intensity interval training will be performed three times a week for a total of six weeks.
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.
Twenty minutes of HIIT will be completed three days a week for six weeks.
Waitlist participants will be tested on the outcomes at the same time points as the treatment group.
University of Georgia
Athens, Georgia, 30605, United States
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.
Patrick J O'Connor, PhD
University of Georgia
41 participants (actual enrollment reported by the registry).
First Submitted
September 28, 2021
First Posted
October 28, 2021
Study Start
January 24, 2022
Actual (reported)Cardiovascular Effects of High Intensity Interval Training in Individuals With Paraplegia
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 31, 2023
Actual (reported)Study Completion
March 31, 2023
Actual (reported)Last Updated
April 18, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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