NCT05142618

Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.

Conditions

• Ventral Hernia
• Hernia
• Herniorrhaphy
• Abdominal Wall
• Postoperative Period
• Physical Therapy Modalities

Interventions

Type	Name	Description
OTHER	Supervised Physical Therapy	The twice-per-week 8-week course of supervised physical therapy begins 2 weeks after surgery. It targets abdominal core function through progressive muscle retraining and strengthening, and patient-specific posture and body mechanics education.
OTHER	Post-operative Precautions	This intervention includes standard of care post-operative instructions typically given to patients undergoing ventral hernia repair across the world. These include limiting strenuous physical activity and a lifting restriction of no more than 10 pounds for 6 weeks. Binder use is also encouraged for 4-6 weeks after the operation.

Timeline

• Start date: 2022-04-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2021-12-02
• Last updated: 2024-12-24

Locations

1 site across 1 country: United States