Exercise for Women Veterans With Histories of Sexual Violence

Overseen By Michelle M Pebole, PhD MA

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurological disorder, Seizure, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking antidepressants, you must have a stable regimen, and if you are in psychotherapy, you should continue it throughout the trial.

What data supports the effectiveness of the treatment Trauma-Informed Exercise Intervention for women veterans with histories of sexual violence?

Research shows that exercise can improve mental health, including reducing PTSD symptoms, as seen in studies with older veterans. Exercise also offers benefits like better physical performance and psychological outlook, which are important for survivors of sexual violence. ^{1 2 3 4 5}

Is trauma-informed exercise safe for women veterans with histories of sexual violence?

A study on a 12-week exercise program for women veterans with PTSD found it to be safe and feasible, suggesting that trauma-informed exercise is generally safe for this population. ^{1 3 5 6 7}

How is the Trauma-Informed Exercise Intervention treatment unique for women veterans with histories of sexual violence?

The Trauma-Informed Exercise Intervention is unique because it incorporates women-specific trauma-informed principles into exercise programs, focusing on the specific needs and experiences of women survivors of sexual violence. This approach aims to address both mental and physical health outcomes by creating a supportive and understanding environment tailored to the trauma-affected population. ^{1 3 6 7 8}

What is the purpose of this trial?

Exposure to sexual violence disproportionally impacts women Veterans and can have profound negative impacts on daily functioning. Current treatments for sexual violence focus on psychiatric symptoms and ignore frequently co-occurring physical and psychosocial concerns. Exercise can improve trauma-related physical, mental, and psychosocial health conditions and may help women who have experienced sexual violence. Yet, women Veterans experience many barriers to participating in exercise and prefer interventions that are tailored to their preferences. This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence. Treatment development will be informed by women Veterans with histories of sexual violence and their providers. Feasibility and acceptability will be tested, and outcomes will be explored to inform future research. This intervention is urgently needed to address gaps in integrative care and persistent trauma-related health concerns among women Veterans with histories of sexual violence.

Research Team

Michelle M Pebole, PhD MA

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Eligibility Criteria

This trial is for women Veterans aged 21-65 who have experienced sexual violence, do not currently exercise regularly, and face some daily functional difficulties. They must have a safe private space for virtual exercise but cannot join if they have severe substance use disorders, significant neurological or systemic illnesses, recent seizures, uncontrolled diabetes, end-stage liver disease or dialysis needs.

Inclusion Criteria

I am a veteran and identify as a woman.

Has a history of sexual violence at any point in their lifetime

Safe and private location to engage in the virtual exercise program

Exclusion Criteria

Significant cognitive impairment

I have a serious illness that affects my brain function.

I have severe liver disease or am on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Stakeholder interviews with women veterans and healthcare providers to guide intervention development

3 months

Treatment

12-week online physical activity program including aerobic and strength training

12 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up assessments at 12 and 24 weeks

Treatment Details

Interventions

• Trauma-Informed Exercise Intervention

Trial Overview The study is developing and testing an exercise program tailored to the needs of women Veterans with histories of sexual violence. It aims to address both physical and psychosocial health issues resulting from trauma. The intervention's feasibility and acceptability will be evaluated.

Participant Groups

Group I: Exercise Experimental Treatment 1 Intervention

Exercise intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

The Warrior Wellness pilot study aims to assess the feasibility and effectiveness of a 12-week exercise program for older veterans (aged 60 and above) with PTSD, focusing on improving PTSD symptoms and cardiovascular endurance.

This study will provide insights into how regular exercise can impact the health of older veterans with PTSD, potentially leading to better treatment options and improved quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Hall, KS., Morey, MC., Beckham, JC., et al.[2020]

A pilot trial involving 54 veterans aged 60 and older with PTSD showed that supervised exercise training is safe and well-accepted, with high adherence rates of 82% and minimal attrition of 14%.

Participants experienced clinically significant improvements in PTSD symptoms and related conditions after 12 weeks of exercise, suggesting that exercise could be an effective intervention for older adults with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. Hall, KS., Morey, MC., Bosworth, HB., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Perceived Barriers and Benefits of Exercise Among Women Survivors of Sexual Violence by Physical Activity Level and Posttraumatic Stress Disorder Status. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Perceived Barriers and Benefits of Exercise Among Men with Histories of Sexual Violence: Impact of PTSD and Physical Activity Status. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of exercise training for older veterans with PTSD. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Insights Following Implementation of an Exercise Intervention in Older Veterans with PTSD. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Exercise for PTSD in Women Veterans: A Proof-of-Concept Study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Trauma-informed exercise for women survivors of sexual violence. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Physical activity promotion in women with PTSD: What we need for progress. [2022]