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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07145099
Status
Not Yet Recruiting

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Conditions

  • Post Operative Pain
  • Ventral Hernia
  • Ventral Incisional Hernia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • PT Group — OTHER
    Exercise, Manual Therapy, and education
  • Usual Care — OTHER
    Education

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Sep 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PT Group
    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.
  • Active Comparator: Usual Care
    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).

Primary Outcome Measure

Abdominal Hernia Surgery Quality of Life Questionnaire [ Time Frame: 2, 12, and 52 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-5084-

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By research site
Thomas Jefferson University· Philadelphia, PA

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