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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | High-intensity interval training will be performed three times a week for a total of six weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity Interval Training (HIIT) | Behavioral | Twenty minutes of HIIT will be completed three days a week for six weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J O'Connor, PhD | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Georgia | Athens | Georgia | 30605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40056660 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2021 |
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| Waitlist | Other | Waitlist participants will be tested on the outcomes at the same time points as the treatment group. |
|
| Oct 14, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2021 | Oct 14, 2021 | ICF_001.pdf |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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