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

NCT07145099 | Not Yet Recruiting DMC

• 1 other identifier: iRiSIDPending
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventral Hernia; Ventral Incisional Hernia; Post Operative Pain

Keywords

Physical Therapy; Rehabilitation; Economic Impact

Outcome Measures

Primary Outcomes (1)

• Abdominal Hernia Surgery Quality of Life Questionnaire

  a validated patient-reported outcome measure assessing the impact of abdominal wall hernias and their repair on various aspects of quality of life. Scores are typically summed 0-100 with higher scores better.

  2, 12, and 52 weeks.

Secondary Outcomes (12)

• Bowel Obstruction Occurrence Rate

  52 weeks.

• Incidence of Spine/Pelvic Floor Diagnosis

  52 weeks.

• Pain Intensity (SF-MPQ-2)

  2, 12, and 52 weeks.

• Pain Intensity (NPRS)

  2, 12, and 52 weeks.

• PROMIS Pain Interference

  2, 12, and 52 weeks.

Other Outcomes (2)

• Complications & Healthcare Utilization

  52 weeks

• Economic Analysis

  52 weeks

Study Arms (2)

PT Group

EXPERIMENTAL

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.

Other: PT Group

Usual Care

ACTIVE COMPARATOR

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).

Other: Usual Care

Interventions

PT Group OTHER

Exercise, Manual Therapy, and education

PT Group

Usual Care OTHER

Education

Usual Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be aged 18-75.
• Diagnosed clinically or via objective testing by a surgeon with a ventral transverse hernia \>4 cm and \<10 cm.
• Scheduled for elective surgical correction of a non-recurrent, primary or incisional ventral hernia.
• Independent functional status.

You may not qualify if:

• Individuals currently receiving or who have received PT within the last 30 days.
• Individuals currently using an assistive device for ambulation.
• Individuals diagnosed with a neurologic disorder will be excluded.
• History of or plan for Botox injection or muscle release related to the hernia.
• Pregnancy

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107-5084, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Pain, Postoperative

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Christopher Keating

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Keating, PhD

CONTACT

2155041647; christopher.keating@jefferson.edu

Sami Tannouri, MD

CONTACT

215-955-6864; Sami.Tannouri@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 28, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available upon the end of the study.
• Access Criteria: Email

Locations

US (1)