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Behavioural Intervention

Physical Therapy for Ventral Hernia Repair (ABVENTURE-P Trial)

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of ventral hernia

Transverse hernia width of 2cm or greater

Must not have

Previously diagnosed movement or balance disorder

Use of ambulatory assistive device (walker or cane)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline before surgery, 30 days after surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at whether physical therapy can help improve outcomes for people who have had surgery to repair a hernia.

Who is the study for?

This trial is for adults over 18 with a ventral hernia that's at least 2cm wide, who can move around on their own and are scheduled for elective hernia repair surgery. It's not for those using walkers or canes, already in physical therapy, or with movement/balance disorders.

What is being tested?

The study is testing if supervised physical therapy helps people recover better after they've had surgery to fix a ventral hernia. Participants will follow post-operative precautions alongside the therapy.

What are the potential side effects?

While the trial itself doesn't involve medication that could cause typical side effects, participants may experience soreness or discomfort from the physical therapy exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a ventral hernia.

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My hernia is wider than 2cm.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a movement or balance disorder.

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I use a walker or cane to help me walk.

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I am not currently in, nor planning to start, physical therapy or similar medical exercise programs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline before surgery, 30 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline before surgery, 30 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline before surgery, 30 days after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Hernia recurrence inventory

Other study objectives

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

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

Change from Baseline in Quiet unstable sitting test

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Supervised Physical TherapyExperimental Treatment1 Intervention

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.

Group II: Standard Post-operative InstructionsActive Control1 Intervention

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

0 / 6Eligibility criteria met