Recruiting

Exercise Intervention

Sponsor:

VA Office of Research and Development

Code:

NCT06746740

Conditions

Sexual Violence

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

Brief summary:

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.

Conditions

Sexual Violence

Study ID

NCT06746740

Start date

Oct 1, 2025

Status verified date

Oct, 2025

Completion date

Mar 31, 2030

Anticipated

Primary completion date

Mar 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Veteran self-identifies as woman
  • has a history of sexual violence at any point in their lifetime
  • between the ages of 21 an 65
  • currently does not meet physical activity level guidelines
  • reports some functional difficulties that indicate some interference in daily life
  • safe and private location to engage in the virtual exercise program

Exclusion Criteria:

  • does not identify a safe and private location for exercise participation
  • severe drug or alcohol use disorder within the past year
  • clinically significant:

  • neurological disorder
  • systemic illness affecting central nervous system function
  • history of seizure disorder in the past 5 years
  • uncontrolled diabetes
  • end stage liver disease or currently receiving dialysis
  • physical disabilities precluding use of exercise equipment
  • significant cognitive impairment
  • active signs and symptoms of CVD
  • metabolic
  • renal disease
  • if taking antidepressants must have stable regimen
  • if in psychotherapy maintain therapy throughout trial

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise

Exercise intervention

Interventions

Exercise

Adapted with input from phase 1

Primary outcome measure

  • Feasibility - recruitment interest [ Time Frame: through study completion, an average of one year ]
  • feasibility, enrollment rate [ Time Frame: through study completion, an average of one year ]
  • feasibility qualitative via Narrative Evaluation of Intervention Interview [ Time Frame: Through study completion, an average of 3 months. ]
  • acceptability - Veteran adherence [ Time Frame: Through study completion, an average of one year. ]
  • Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change [ Time Frame: assessed at BL, 12 weeks, 24 week follow up ]

Central Contacts and Locations

Central contacts

Michelle M Pebole, PhD MA

(857) 364-4989michelle.pebole@va.gov

Locations

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

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Michelle M Pebole, PhD MA

857-364-4989michelle.pebole@va.gov

Principal Investigator:

Michelle M Pebole, PhD MA

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • women Veterans
  • sexual violence
  • exercise
  • transdiagnostic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-23.