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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new exercise program specifically designed for women Veterans who have experienced sexual violence. The goal is to determine if this tailored exercise can improve both physical and mental health, addressing often-overlooked issues like trauma. Women Veterans who have faced sexual violence, are not currently meeting exercise guidelines, and find daily life challenging might be suitable candidates for this trial. The study will assess the practicality and effectiveness of the exercise program, aiming to fill a gap in care for these women. As an unphased trial, it offers participants the opportunity to contribute to groundbreaking research that could lead to improved care for women Veterans.

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 prior data suggests that this exercise intervention is safe for women Veterans?

Research has shown that exercise can be safe and beneficial for women who have experienced sexual violence. Studies suggest that physical activity may enhance both mental and physical health for these women. This exercise program is specifically designed to meet the needs and preferences of women Veterans who have faced sexual violence.

Specific data on negative side effects from this type of exercise is lacking. However, exercise is generally safe and often recommended for better health. The program is designed to be sensitive to the experiences of these women, ensuring it feels safer and more comfortable. The goal is to provide a supportive environment where participants can exercise without added stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for women with histories of sexual violence focus on therapy and medication to address trauma and mental health issues. However, the trauma-informed exercise intervention stands out because it integrates physical activity with a deep understanding of trauma, aiming to help women reconnect with their bodies in a safe and supportive way. This approach is unique in that it combines exercise with psychological healing, potentially offering both physical and emotional benefits. Researchers are excited about this intervention because it could provide a holistic alternative to standard treatments, empowering women to take an active role in their recovery.

What evidence suggests that this exercise intervention is effective for women Veterans with histories of sexual violence?

Research has shown that exercise can greatly enhance both mental and physical health for individuals with posttraumatic symptoms. In this trial, participants will engage in a trauma-informed exercise intervention, which considers the specific needs and experiences of trauma survivors. This approach has been particularly beneficial for women who have experienced sexual violence. Studies have found that these exercise programs can lead to improved mental health, such as reduced anxiety and depression, and better physical health. Women veterans have expressed strong interest in these customized exercise programs, indicating their potential effectiveness. Overall, exercise could significantly boost well-being in this group. ^{1 2 4 5 6}

Who Is on the Research Team?

Michelle M Pebole, PhD MA

Principal Investigator

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

Are You a Good Fit for This Trial?

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 a metabolic disease.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06746740

Developing and Testing a Trauma-Informed Exercise ... This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence. Treatment development ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32535635/

Trauma-informed exercise for women survivors of sexual ... Exercise has been shown to positively impact both mental and physical health outcomes in populations experiencing posttraumatic symptoms, yet ...

3. trialx.com trialx.com/clinical-trials/listings/325308/developing-and-testing-a-trauma-informed-exercise-intervention-for-women-veterans-with-histories-of-sexual-violence/

Developing and Testing a Trauma-Informed Exercise ... This proposal will develop and test an exercise intervention tailored specifically to women Veterans who have experienced sexual violence.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1469029225001682

Insights from women veterans on trauma-informed exercise ... Twelve WVs (mean age = 47.7 years; 58.3 % white; 58.3 % lifetime PTSD; 33.3 % lifetime TBI) completed the survey and interview. All WVs were interested in an ...

5. researchgate.net researchgate.net/publication/362396138_Exercise_Preferences_Among_Women_Survivors_of_Sexual_Violence_by_PTSD_and_Physical_Activity_Level_Implications_and_Recommendations_for_Trauma-Informed_Practice

Exercise Preferences Among Women Survivors of Sexual ... Women with PTSD were more likely to prefer at home options, with women instructors, moderate-high intensity, longer sessions, and longer program durations, ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1469029221000807

Physical activity to address multimorbidity among survivors ... Results broadly indicate that levels of physical activity among survivors of SV is unclear. Findings from trials indicate exercise may have a positive impact ...