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ABVENTURE-P: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair

ABVENTURE-P：腹部核心康复试点试验，以改善腹疝修复后的结果

基本信息

批准号：
10675560
负责人：
Ajit Mohan Worthen Chaudhari
金额：
$ 26.67万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-30 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10675560
关键词：
Abdomen Activities of Daily Living Address Affect Anterior Back Clinical Clinical Trials Conduct Clinical Trials Data Development Disease Enrollment Exercise Foundations Functional disorder Funding Goals Health Hernia Human Hygiene Individual Infrastructure Innovative Therapy Intervention Measurable Measures Medical Mission Modeling Multi-Institutional Clinical Trial National Institute of Diabetes and Digestive and Kidney Diseases Operative Surgical Procedures Outcome Participant Patient Outcomes Assessments Patient Self-Report Patient-Focused Outcomes Patients Pelvic floor structure Performance Personal Satisfaction Persons Physical Function Physical Rehabilitation Physical therapy Population Postoperative Period Prevention Protocols documentation Public Health Quality of life Randomized Randomized, Controlled Trials Registries Rehabilitation therapy Replacement Arthroplasty Reporting Research Respiration Respiratory Diaphragm Role Standardization Structure Surveys Testing Time Treatment Efficacy United States United States National Institutes of Health Variant Ventral Hernia Vertebral column Work abdominal wall design disability effective therapy evidence base functional improvement improved improved outcome innovation intervention effect medical specialties novel patient oriented patient registry pilot trial post-operative rehabilitation primary endpoint prospective recruit repaired retention rate standard of care therapy development treatment center treatment group

项目摘要

PROJECT SUMMARY ABSTRACT This study aims to evaluate the potential role of physical therapy (PT) in improving outcomes after ventral hernia repair. The long-term goal is to develop therapies to improve function of the abdominal core musculature and to regain quality of life considering the abdominal core’s inter-related components. Our central hypothesis is that patients undergoing a specific type of hernia repair, ventral hernia repair, will have measurably improved functional capacity and quality of life following rehabilitation that addresses the mechanism of both loss and gain of abdominal core function. The rationale for this project is a novel conceptual model that enables innovative therapies incorporating abdominal core function as the summative functions of the abdominal wall, lower back, diaphragm, and pelvic floor, which contribute to activities of daily living and quality of life. The central hypothesis will be tested with a feasibility randomized controlled trial of standardized post-operative physical therapy that pursues three specific aims: 1) establish the efficacy of post-operative physical therapy to improve function and patient-reported outcomes after ventral hernia repair; 2) establish the feasibility of post-operative physical therapy to improve functional and clinical outcomes in individuals undergoing ventral hernia repair; and 3) determine whether baseline abdominal core function influences the efficacy of post-operative physical therapy after ventral hernia repair. This prospective registry-based RCT will leverage current infrastructure within the Abdominal Core Health Quality Collaborative, a national registry of patients with hernia disease and diseases of the abdominal wall, to collect key clinical measures along with additional measures of function added for this study. A standardized PT protocol will be administered to a randomized group of participants. Under the first aim, function is primarily assessed using the Five Times Sit-to-Stand, and patient-reported outcomes using the PROMIS-Physical Function survey. Primary timepoints include pre-op and 10 weeks post-op at the conclusion of rehabilitation, with additional timepoints at 30 days, 6 months and 1-year post-op. For the second aim, we strive to assess the feasibility of the registry-based RCT design and postoperative physical therapy by measuring retention and compliance rates. For the third aim, we will use our novel quantitative, continuous abdominal core function assessment (QUeST) at primary and intermediate timepoints to help identify those who may benefit most from postoperative PT. The research proposed is innovative because it breaks down silos of expertise and structures examined. It leverages diverse and complementary perspectives from different surgical and rehabilitation specialties in a holistic manner. This contribution is expected to be significant as it will lead to a well-powered definitive multi-center clinical trial to reduce the medical and societal burden of ventral hernia on the US population.