RecruitingACTRN12624000893505

Therapeutic intervention for intimate partner violence survivors with PTSD

Aerobic Exercise as a Therapeutic Intervention for Women Who Have Experienced Intimate Partner Violence (IPV) with Post-traumatic Stress Disorder (PTSD)

Sponsor

Monash University

Enrollment

120 participants

Start Date

May 16, 2024

Study Type

Interventional

Conditions

Intimate Partner Violence Survivors with PTSD PTSD

Summary

In 2014, Australia declared intimate partner violence (IPV) a national emergency reported to affect one in six women. Unfortunately, the prevalence, severity, and frequency of IPV have been exacerbated since the outbreak of COVID-19, with more recent estimates of IPV reported to affect up to 1 in 4 Australian women and is the leading cause of preventable death, disability, and illness among women aged 15-44. Of the many challenges faced by IPV survivors, post-traumatic stress disorder (PTSD) is notable, with an estimated prevalence of up to almost 64% of survivors, irrespective of the type of IPV experienced. Also, 60-92% of women facing physical IPV experience facial/head injuries, including mild traumatic brain injury or non-fatal strangulation events, which can lead to persistent post-concussion symptoms (PPCS). The primary aim of this study is to determine whether aerobic exercise intervention can improve outcomes in IPV survivors with post-traumatic stress disorder (PTSD). Secondary to this is whether this intervention is effective in women who have experienced intimate partner violence brain injury (IPV-BI) experiencing persistent post-concussion symptoms (PPCS). In addition, we hope to identify objective markers in the blood to supplement our knowledge of improvement. Exercise intervention holds promise as a readily available, easy-to-apply, non-pharmacological treatment for PTSD and PPCS and offers a highly accessible option for healthcare providers. This project hopes to address the urgent need for an effective intervention in this underserved population.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria5

Female participants aged between 18-70 years providing informed consent
Self-report history of IPV (> 3 months)
Probable post-traumatic stress disorder as measured by Post traumatic Stress Disorder Checklist PCL-5
Have daily access to a smartphone and internet
Eligible for Medicare

Exclusion Criteria19

Subjects who are not willing or able to exercise due to health or personal reasons (e.g. orthopaedic injury, cervical spine injury, diabetes, known heart disease or musculoskeletal injuries which could make exercise difficult or painful) via Physical Activity Readiness questionnaire used (PAR-Q).
Increased cardiac risk indicated by two or more of the following:
a) Prior diagnosis of, or currently taking medication for cardiovascular (e.g., beta-blockers), metabolic or pulmonary conditions;
b) Family history of myocardial infarction, coronary revascularisation or sudden death before 55 years;
c) Diagnosis of hypertension;
d) Diagnosis of hyperlipidemia;
e) Subjects with peripheral circulatory disorders.
History of prior head injury as defined by:
a) Any head injury within the last 30 days
b) Moderate or severe TBI, defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less
Diagnosis of a neurological (e.g., stroke, multiple sclerosis, epilepsy, brain tumour/cancer, encephalitis, dementia, movement disorder, or spontaneous nystagmus)
History of drug or alcohol dependency or abuse within a year before screening by self-report
Limited English proficiency precluding completion of measures
Significant psychiatric history (e.g. psychiatric hospitalisation, schizophrenia, history of legal trouble for violence)
IPV history < 3 month
No PTSD symptomology at the initial visit (i.e., asymptomatic).
Sustaining another head injury during the research period
New (< 1 month) or non-stable or pharmacological regimen prior to intervention (regiment must be maintained for the duration of intervention)
Exercise-tolerant individuals with a current activity level equal to or greater than the proposed intervention

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Interventions

Women with a history of intimate partner violence will be contacted with consent from previous studies to confirm eligibility for this study. Only participants who meet all inclusion and exclusion criteria will be recruited for the initial visit. During the screening visit, participants will be interviewed in one-on-one sessions and asked to complete questionnaires for data collection and confirmation of the inclusion criteria described below: The Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5): to evaluate PTSD and proceed with admission only for participants who score 30 or higher. Participants will also be asked to perform the Buffalo Concussion Bike Test (BCBT), a graded exertion test for assessing exercise tolerance after a concussion. During this test, participants will cycle on a stationary bike. Every two minutes, the exercise intensity will increase for a maximum of 30 minutes. Every 2 minutes, participants will also indicate their symptom severity using the Visual Analogue Scale (VAS) and perceived exertion on the Borg Ratings of Perceived Exertion (RPE) scale (6-20). Heart rate will be recorded using a Fitbit (Inspire 3) and an electrocardiogram (ECG). This test identifies the heart rate (HR) at which symptom exacerbation occurs (i.e., Heart Rate Threshold [HRt]). Based on the results of the BCBT, participants will be allocated into three possible interventions: Exercise Intolerant Group: Participants who are exercise intolerant will be randomly assigned to one of two groups in a parallel design. One group will receive a 4-week sub-symptom threshold aerobic exercise (STAE) intervention (20 minutes per day), while the other group will receive a placebo-like passive stretching intervention (allocation ratio 1:1). The STAE target HR will be 80% of the HR achieved at symptom exacerbation during the most recent BCBT visit. Exercise Tolerant Group: Participants who are exercise tolerant will be randomly assigned to one of two groups in a parallel design. One group will receive a 4-week standard aerobic exercise intervention, while the other will receive a placebo-like passive stretching intervention (allocation ratio 1:1). Participants will be instructed to complete 20 minutes of aerobic exercise daily at home or in a gym at the prescribed target HR, The prescribed heart rate will be 50-65% of the age-predicted maximum heart rate. Participants assigned to either the STAE intervention or the standard aerobic exercise intervention (AE) have the option to exercise at home or at a gym. They can choose to perform the STAE or AE intervention in any way they prefer, such as walking, jogging, or stationary cycling, but they will be advised to minimize neck motion during exercise. Both interventions consist of a 5-minute warm-up, a minimum of 20 minutes at the designated heart rate, and then a 5-minute cool-down. All participants will be provided with an activity tracker (Fitbit Inspire 3) to monitor their heart rate and adherence to the protocol. Using the Fitabase platform, research staff will have daily access to participants' activity tracker data, including intensity, heart rate, and exercise logs. Participants will also be asked to complete a weekly survey to confirm adherence to the protocol. All participants, regardless of the treatment group, will be reassessed weekly for exercise tolerance. Upon completing the initial 4 weeks, participants in either treatment group will be offered an additional 4 weeks of the intervention, with all processes repeated to assess any changes over an 8-week timeframe. Data from these optional assessments will be analysed together with the data from the first 4 weeks.