Aerobic exercise as a therapeutic intervention for post-traumatic stress disorder in women who have experienced intimate partner violence: study protocol for an open-label randomised controlled trial

BACKGROUND: Women with a history of intimate partner violence (IPV) are at risk for post-traumatic stress disorder (PTSD). The effectiveness of aerobic exercise in reducing PTSD symptom burden has been established in other patient populations; however, its utility in the context of IPV victim-survivors has received little investigation. Therefore, the primary aim of this study is to determine if 4 weeks of daily structured aerobic exercise compared to daily stretching can reduce PTSD symptom burden in women IPV victim-survivors, offering a potential accessible and self-directed treatment avenue. METHODS: The target sample size of 120 women (aged 18-70) with a history of IPV (last instance > 3 months ago) and probable PTSD (via the PTSD Checklist for DSM-5; PCL-5) will be recruited via community advertisement in Melbourne, Australia. The trial will be completed at the Alfred Centre, Monash University. Participants will complete an exercise tolerance test via the Buffalo Concussion Bike Test and then will be randomised into either aerobic exercise or passive stretching. Participants will be instructed to complete 20 min of allocated aerobic exercise or stretching for 4 weeks and given a written diary and a Fitbit smartwatch to track program adherence. The primary outcome, PTSD symptoms via the PCL-5, will be collected at baseline, 1, 2, 3, and 4 weeks (primary endpoint). Secondary outcomes, including additional determinants of health (i.e. sleep, pain, substance use), cognitive testing, concussion-like symptoms in participants with a history of IPV-related brain injury, blood-based biomarkers, and feasibility and adherence to the prescribed program, will also be collected weekly at baseline, 1-, 2-, 3-, and 4-week follow-ups. DISCUSSION: This trial is an open-label randomised controlled trial to compare the effectiveness of a structured aerobic exercise program to passive stretching in women victim-survivors of IPV with probable PTSD. Results from this trial will help guide the development of individualised, financially accessible, and self-directed care plans for women living with PTSD and other persisting mental and physical health impacts of IPV. TRIAL REGISTRATION: ACTRN12624000893505. Trial registered retrospectively. Registered on 22/07/2024. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624000893505.