πŸ›οΈ Verified NIH Record β€’ Updated 2025-09-02

The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery (NCT07145099)

The IMPACT Study: A Randomized Controlled Trial of Individualized Management Post Ventral Hernia Repair (VHR) Utilizing Abdominal Core Therapy for Enhanced Recovery and Health Outcomes

🟑 Not Yet Recruiting Observational / Diagnostic πŸ“‹ Clinical Research Protocol Sponsor: Thomas Jefferson University

🩺 Plain-English Summary (8th-Grade Level)

The goal of this clinical trial is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) intervention targeting Abdominal Core Health components in patients recovering from ventral hernia repair. The study focuses on patients aged 18-75 diagnosed with a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective Ventral Hernia Repair (VHR). The main questions it aims to answer are: * Will tailored PT significantly improve abdominal core strength, biomechanical stability, and functional mobility compared to usual care at 3-months post-surgery? * Will tailored PT lead to higher patient-reported quality of life and satisfaction scores, with a lower incidence of post-operative complications such as bowel obstruction and pelvic floor dysfunction over a 1-year follow-up? * Will tailored PT result in decreased healthcare utilization, leading to overall cost savings or neutrality compared to usual care over the first year after VHR? Researchers will compare the tailored physical therapy group to a usual care group to see if the tailored intervention leads to significant improvements in clinical efficacy, patient outcomes, and cost-effectiveness. Participants will: * Be randomly assigned to either the Usual Care Group or the PT Group. * If in the Usual Care Group, receive standard post-operative instructions for 12 weeks, including guidance on binder use, safe lifting, and gradual return to activities. * If in the PT Group, receive foundational post-operative instructions for the first 2 weeks (similar to usual care). Undergo 6 structured and individualized PT sessions over 10 weeks if in the PT Group, with progression based on Oswestry Disability Index (ODI) and Pelvic Floor Distress Inventory-20 (PFDI-20) scores, including Symptom Modulation, Movement Control, Functional Optimization, or Impairment-Based interventions. Participants undergo data collection at 2 weeks, 12 weeks, and 1 year post-operation, including imaging, functional mobility tests, pain scales, patient-reported outcomes, physical measurements, and tracking of complications and healthcare utilization. Participate in semi-structured interviews after the 12-week assessment to provide qualitative insights into their experiences and perceived barriers/facilitators.

Who can join: Review the eligibility criteria below.

Location: Thomas Jefferson University β€” Philadelphia, Pennsylvania

Age range: 18 Years to 75 Years

πŸ§ͺ Interventions in This Study

  • PT Group (OTHER)
  • Usual Care (OTHER)

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (1 Sites)

  • Thomas Jefferson University β€” Philadelphia, Pennsylvania

πŸ“ž Contact the Study Coordinator

Phone: (215) 504-1647

Email: christopher.keating@jefferson.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Ventral Hernia clinical trials

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—