The IMPACT Study: Personalized Physical Therapy for Better Recovery and a Stronger Core After Hernia Surgery
Public ClinicalTrials.gov record NCT07145099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07145099
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2027
- Last update posted
- Sep 9, 2025
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107-5084 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07145099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07145099 live on ClinicalTrials.gov.