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

Not Applicable

Active, not recruiting

• Conditions: Abdominal Wall; Ventral Hernia; Hernia; Herniorrhaphy; Physical Therapy Modalities; Postoperative Period
• Interventions: Other: Supervised Physical Therapy; Other: Post-operative Precautions

• Registration Number: NCT05142618
• Lead Sponsor: Ohio State University

Brief 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.

Study Timeline

• Study First Submitted: 2021-11-03
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Study Start: 2022-04-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised Physical Therapy	Supervised Physical Therapy	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.
Standard Post-operative Instructions	Post-operative Precautions	Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function	Baseline before surgery, 10 weeks after surgery	Computer-adaptive patient-reported questionnaire asking questions about physical function.
Change from Baseline in Quiet unstable sitting test	Baseline before surgery, 10 weeks after surgery	Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Change from Baseline in Five times sit-to-stand time	Baseline before surgery, 10 weeks after surgery	From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.

Secondary Outcome Measures

Name	Time	Method
Change in Hernia related quality of life survey from baseline	baseline before surgery, 1 year after surgery	Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.
Change in Timed Up-And-Go time from baseline	baseline before surgery, 1 year after surgery	Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down. Do all of these as quickly as can be done safely.
Change from baseline in International Physical Activity Questionnaire - Short Form	baseline before surgery, 10 weeks after surgery	Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Hernia recurrence inventory	1 year after surgery	Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.
Change from baseline in International Physical Activity Questionnaire - Long Form	baseline before surgery, 1 year after surgery	Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
Change from Baseline in Five times sit-to-stand time	baseline before surgery, 1 year after surgery	From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
Change from Baseline in Quiet unstable sitting test	baseline before surgery, 1 year after surgery	Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
Change from baseline in Tampa Scale of Kinesiophobia - Short Form	baseline before surgery, 1 year after surgery	Self-reported questions on how fear affects desire and ability to perform physical activities.
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function	baseline before surgery, 1 year after surgery	Computer-adaptive patient-reported questionnaire asking questions about physical function.

Trial Locations

Locations (1)

Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States