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

NCT05142618 | Active Not Recruiting DMC

• 2 other identifiers: 2021H0336R01DK131207
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

ventral hernia repair; abdominal core health; physical therapy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Five times sit-to-stand time

  From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.

  Baseline before surgery, 10 weeks after surgery

• Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function

  Computer-adaptive patient-reported questionnaire asking questions about physical function.

  Baseline before surgery, 10 weeks after surgery

• Change from Baseline in Quiet unstable sitting test

  Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.

  Baseline before surgery, 10 weeks after surgery

Secondary Outcomes (12)

• Change in Hernia related quality of life survey from baseline

  baseline before surgery, 10 weeks after surgery

• Change in Timed Up-And-Go time from baseline

  baseline before surgery, 10 weeks after surgery

• Change from baseline in International Physical Activity Questionnaire - Short Form

  baseline before surgery, 10 weeks after surgery

• Change from baseline in Tampa Scale of Kinesiophobia - Short Form

  baseline before surgery, 10 weeks after surgery

• Hernia recurrence inventory

  1 year after surgery

Other Outcomes (14)

• Change in Hernia related quality of life survey from baseline

  baseline before surgery, 30 days after surgery

• Change in Timed Up-And-Go time from baseline

  baseline before surgery, 30 days after surgery

• Change from baseline in International Physical Activity Questionnaire - Short Form

  baseline before surgery, 30 days after surgery

Study Arms (2)

Standard Post-operative Instructions

ACTIVE COMPARATOR

Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.

Other: Post-operative Precautions

Supervised Physical Therapy

EXPERIMENTAL

Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program.

Other: Supervised Physical Therapy

Interventions

Supervised Physical Therapy OTHER

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.

Supervised Physical Therapy

Post-operative Precautions OTHER

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.

Standard Post-operative Instructions

Eligibility Criteria

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

You may qualify if:

• Ages 18+
• Diagnosis of ventral hernia
• Scheduled for elective ventral hernia repair
• Independent functional status
• Transverse hernia width of 2cm or greater

You may not qualify if:

• Previously diagnosed movement or balance disorder
• Use of ambulatory assistive device (walker or cane)
• Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional

Sponsors & Collaborators

• Ohio State University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Hernia, Ventral; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 2, 2021
• Study Start: April 19, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)