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

Ventral Hernia Clinical Trial

— ABVENTURE-P  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05142618
• Other study ID #: 2021H0336
• Secondary ID: R01DK131207
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: Stephanie Di Stasi, PT, PhD
• Phone: 614-293-4220
• Email: abventuretrial[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 30, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Ages 18+

• Diagnosis of ventral hernia

• Scheduled for elective ventral hernia repair

• Independent functional status

• Transverse hernia width of 2cm or greater

Exclusion Criteria

• 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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Hernia related quality of life survey from baseline	Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.	baseline before surgery, 30 days after surgery
Other	Change in Timed Up-And-Go time from baseline	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.	baseline before surgery, 30 days after surgery
Other	Change from baseline in International Physical Activity Questionnaire - Short Form	Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.	baseline before surgery, 30 days after surgery
Other	Change from baseline in Tampa Scale of Kinesiophobia - Short Form	Self-reported questions on how fear affects desire and ability to perform physical activities.	baseline before surgery, 30 days after surgery
Other	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, 30 days after surgery
Other	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, 30 days after surgery
Other	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, 30 days after surgery
Other	Change in Hernia related quality of life survey from baseline	Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.	baseline before surgery, 6 months after surgery
Other	Change in Timed Up-And-Go time from baseline	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.	baseline before surgery, 6 months after surgery
Other	Change from baseline in International Physical Activity Questionnaire - Long Form	Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.	baseline before surgery, 6 months after surgery
Other	Change from baseline in Tampa Scale of Kinesiophobia - Short Form	Self-reported questions on how fear affects desire and ability to perform physical activities.	baseline before surgery, 6 months after surgery
Other	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, 6 months after surgery
Other	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, 6 months after surgery
Other	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, 6 months after surgery
Primary	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
Primary	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
Primary	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	Change in Hernia related quality of life survey from baseline	Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.	baseline before surgery, 10 weeks after surgery
Secondary	Change in Timed Up-And-Go time from baseline	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.	baseline before surgery, 10 weeks after surgery
Secondary	Change from baseline in International Physical Activity Questionnaire - Short Form	Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.	baseline before surgery, 10 weeks after surgery
Secondary	Change from baseline in Tampa Scale of Kinesiophobia - Short Form	Self-reported questions on how fear affects desire and ability to perform physical activities.	baseline before surgery, 10 weeks after surgery
Secondary	Hernia recurrence inventory	Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.	1 year after surgery
Secondary	Change in Hernia related quality of life survey from baseline	Patient-reported questionnaire asking questions about abdominal wall function including activities of daily living, independent mobility, and mental health.	baseline before surgery, 1 year after surgery
Secondary	Change in Timed Up-And-Go time from baseline	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.	baseline before surgery, 1 year after surgery
Secondary	Change from baseline in International Physical Activity Questionnaire - Long Form	Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.	baseline before surgery, 1 year after surgery
Secondary	Change from baseline in Tampa Scale of Kinesiophobia - Short Form	Self-reported questions on how fear affects desire and ability to perform physical activities.	baseline before surgery, 1 year after surgery
Secondary	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, 1 year after surgery
Secondary	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, 1 year after surgery
Secondary	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, 1 year after surgery