Physical Therapy for Ventral Hernia

(IMPACT Trial)

Overseen By Sami Tannouri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Neurologic disorder, Pregnancy, others

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

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether personalized physical therapy aids recovery after ventral hernia repair surgery. It examines if a customized exercise plan improves core strength, stability, and mobility more effectively than standard care. Researchers will also assess whether this approach enhances patient satisfaction and health a year post-surgery, while potentially reducing medical costs. Individuals with a ventral hernia between 4 cm and 10 cm who are planning surgery may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery and overall well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this physical therapy intervention is safe for patients recovering from ventral hernia repair?

Research has shown that personalized physical therapy (PT) is generally safe and well-tolerated by patients recovering from surgeries such as ventral hernia repair. Studies have found that physical therapy can enhance strength and movement without causing significant harm. In past trials, patients did not report any major problems related to PT sessions. Instead, they often experienced better recovery and an improved quality of life.

The personalized PT program in this trial resembles those used in previous studies, which demonstrated positive safety results. This suggests that the treatment is a safe option for individuals seeking to enhance their recovery after hernia surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how personalized physical therapy could enhance recovery after ventral hernia surgery. Unlike the standard care, which involves general post-operative guidance, this approach tailors physical therapy sessions based on individual assessments like the Oswestry Disability Index (ODI) and Pelvic Floor Distress Inventory-20 (PFDI-20) scores. This personalized approach aims to optimize healing by addressing each participant's unique needs, potentially leading to more effective and quicker recoveries.

What evidence suggests that this physical therapy is effective for ventral hernia recovery?

Research has shown that personalized physical therapy (PT), which participants in this trial may receive, can aid recovery after ventral hernia surgery. Studies have found that customized PT strengthens abdominal muscles and improves movement, both crucial for healing. Early results suggest that patients with regular PT sessions experience better well-being and fewer complications, such as bowel blockages. PT may also reduce doctor visits, potentially saving money. While more research is needed, initial evidence supports PT as a promising recovery option after this type of surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Christopher Keating

Principal Investigator

Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 who have a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective repair surgery. Participants must be able to follow the study's procedures and attend physical therapy if assigned.

Inclusion Criteria

I am between 18 and 75 years old.

I can take care of myself without help.

I am scheduled for surgery to fix a new hernia in my abdomen.

Exclusion Criteria

I am currently in physical therapy or finished it within the last 30 days.

I use a device to help me walk.

I do not have a diagnosed neurological disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Protocol

Participants receive foundational post-operative instructions similar to usual care, including guidance on abdominal binder use and safe lifting techniques

2 weeks

1 visit (in-person)

Tailored Physical Therapy

Participants undergo 6 structured and individualized PT sessions over 10 weeks, with progression based on ODI and PFDI-20 scores

10 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging, functional mobility tests, and patient-reported outcomes

52 weeks

3 visits (in-person) at 2, 12, and 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Physical Therapy

Trial Overview The study compares tailored physical therapy (PT) with usual post-operative care in patients recovering from ventral hernia repair. It aims to see if PT improves core strength, stability, mobility, quality of life, reduces complications and healthcare costs over a year.

How Is the Trial Designed?

Group I: PT Group Experimental Treatment 1 Intervention

Initial Protocol (Post-Randomization): Participants will receive foundational instructions like usual care, including: Binder Use: Guidance on abdominal binder use. Lifting Precautions: Instruction on safe lifting techniques to protect the healing abdominal wall. Gradual Return to Activities: Advice on progressively re-engaging in daily activities. Tailored Physical Therapy Sessions (6 Sessions): Following the initial phase, participants will undergo 6 structured PT sessions. The progression and focus of these sessions will be individualized based on the participant's Oswestry Disability Index (ODI) score and Pelvic Floor Distress Inventory-20 (PFDI-20) score.

Group II: Usual Care Active Control 1 Intervention

Protocol: Participants in this group will receive standard post-operative care instructions, which include: Binder Use: Guidance on the appropriate use of an abdominal binder. Lifting Precautions: Instruction on safe lifting techniques to protect the healing abdominal wall. Gradual Return to Activities: Advice on progressively re-engaging in daily activities. Follow-up: Participants will continue with usual care (no PT intervention) after the initial 12 weeks until the final assessment at Testing Session 2 (12 weeks post-operatively).

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07145099

The IMPACT Study: Personalized Physical Therapy for ... The study focuses on patients aged 18-75 diagnosed with a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective Ventral ...

2. reporter.nih.gov reporter.nih.gov/project-details/10675560

Pilot Trial of Abdominal Core Rehabilitation To Improve ... PROJECT SUMMARY ABSTRACT This study aims to evaluate the potential role of physical therapy (PT) in improving outcomes after ventral hernia repair.

3. withpower.com withpower.com/trial/phase-hernia-ventral-2026-c1a53

Physical Therapy for Ventral Hernia (IMPACT Trial) The goal of this clinical trial is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) intervention targeting ...

4. foundation4pt.org foundation4pt.org/bridging-research-and-real-world-practice-stephanie-di-stasi-on-pragmatic-trials-and-hernia-care/

Stephanie Di Stasi on Pragmatic Trials and Hernia Care Di Stasi's ventral hernia disease research aims to integrate physical therapy into postoperative care in a more structured way. Her goal is to ...

5. link.springer.com link.springer.com/article/10.1007/s00464-025-12224-z

Is there a link between physical function testing and ventral ... In conclusion, while this study did not demonstrate a significant relationship between physical function tests and ventral hernia size, it ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10374060/

ABVENTURE-P pilot trial of physical therapy versus standard ... ABVENTURE-P pilot trial of physical therapy versus standard of care following ventral hernia repair: Protocol for a randomized controlled trial

7. springermedicine.com springermedicine.com/physical-therapy/is-there-a-link-between-physical-function-testing-and-ventral-he/51504186

Is there a link between physical function testing and ventral ... Clinical assessments of physical function are widely used to evaluate candidacy and predict outcomes for various procedures.