Clinical trial NCT05142618: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Official title: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ventral Hernia
Hernia
Herniorrhaphy
Abdominal Wall
Postoperative Period
Physical Therapy Modalities
Keywords: ventral hernia repair
abdominal core health
physical therapy
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-12-02
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Five times sit-to-stand time
timeFrame: Baseline before surgery, 10 weeks after surgery
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
timeFrame: Baseline before surgery, 10 weeks after surgery
measure: Change from Baseline in Quiet unstable sitting test
timeFrame: Baseline before surgery, 10 weeks after surgery
Secondary outcomes:
measure: Change in Hernia related quality of life survey from baseline
timeFrame: baseline before surgery, 10 weeks after surgery
measure: Change in Timed Up-And-Go time from baseline
timeFrame: baseline before surgery, 10 weeks after surgery
measure: Change from baseline in International Physical Activity Questionnaire - Short Form
timeFrame: baseline before surgery, 10 weeks after surgery
measure: Change from baseline in Tampa Scale of Kinesiophobia - Short Form
timeFrame: baseline before surgery, 10 weeks after surgery
measure: Hernia recurrence inventory
timeFrame: 1 year after surgery
measure: Change in Hernia related quality of life survey from baseline
timeFrame: baseline before surgery, 1 year after surgery
measure: Change in Timed Up-And-Go time from baseline
timeFrame: baseline before surgery, 1 year after surgery
measure: Change from baseline in International Physical Activity Questionnaire - Long Form
timeFrame: baseline before surgery, 1 year after surgery
measure: Change from baseline in Tampa Scale of Kinesiophobia - Short Form
timeFrame: baseline before surgery, 1 year after surgery
measure: Change from Baseline in Five times sit-to-stand time
timeFrame: baseline before surgery, 1 year after surgery
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
timeFrame: baseline before surgery, 1 year after surgery
measure: Change from Baseline in Quiet unstable sitting test
timeFrame: baseline before surgery, 1 year after surgery
Other outcomes:
measure: Change in Hernia related quality of life survey from baseline
timeFrame: baseline before surgery, 30 days after surgery
measure: Change in Timed Up-And-Go time from baseline
timeFrame: baseline before surgery, 30 days after surgery
measure: Change from baseline in International Physical Activity Questionnaire - Short Form
timeFrame: baseline before surgery, 30 days after surgery
measure: Change from baseline in Tampa Scale of Kinesiophobia - Short Form
timeFrame: baseline before surgery, 30 days after surgery
measure: Change from Baseline in Five times sit-to-stand time
timeFrame: baseline before surgery, 30 days after surgery
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
timeFrame: baseline before surgery, 30 days after surgery
measure: Change from Baseline in Quiet unstable sitting test
timeFrame: baseline before surgery, 30 days after surgery
measure: Change in Hernia related quality of life survey from baseline
timeFrame: baseline before surgery, 6 months after surgery
measure: Change in Timed Up-And-Go time from baseline
timeFrame: baseline before surgery, 6 months after surgery
measure: Change from baseline in International Physical Activity Questionnaire - Long Form
timeFrame: baseline before surgery, 6 months after surgery
measure: Change from baseline in Tampa Scale of Kinesiophobia - Short Form
timeFrame: baseline before surgery, 6 months after surgery
measure: Change from Baseline in Five times sit-to-stand time
timeFrame: baseline before surgery, 6 months after surgery
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
timeFrame: baseline before surgery, 6 months after surgery
measure: Change from Baseline in Quiet unstable sitting test
timeFrame: baseline before surgery, 6 months after surgery
Locations:
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
Study officials:
References: