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

• 批准号: 10344052
• 负责人: Ajit Mohan Worthen Chaudhari
• 金额: $ 25.91万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 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/10344052
• 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; 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; base; design; disability; effective therapy; evidence base; functional outcomes; improved; improved functioning; 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

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.

项目总结摘要 本研究旨在评估物理疗法(PT)在改善腹股沟疝术后预后方面的潜在作用。 修理。长期目标是开发治疗方法，以改善腹部核心肌肉的功能，并 考虑到腹部核心的相互关联的组成部分，恢复生活质量。我们的中心假设是 接受一种特殊类型的疝修补术--腹式疝修补术的患者将会有明显的改善。 康复后的功能能力和生活质量，解决了失去和获得的机制 腹部核心功能。该项目的基本原理是一种新的概念模型，能够实现创新 结合腹部核心功能的治疗，如腹壁、下背部、 横隔膜和盆底，有助于日常生活活动和生活质量。中心假说 将通过一项标准化术后物理治疗的可行性随机对照试验进行测试 追求三个具体目标：1)建立术后物理治疗的疗效，以改善功能和 患者报告腹股沟疝修补术后的结果；2)建立术后物理检查的可行性 治疗以改善腹股沟修补术患者的功能和临床结果；以及3) 确定基线腹主功能是否影响术后物理治疗的疗效 腹股沟修补术后。这一基于注册表的预期RCT将利用 腹壁核心健康质量协作组，一家全国性的腹股沟和腹股沟疾病患者登记机构 腹壁，以收集关键的临床措施以及为此增加的额外功能措施 学习。将对随机分组的参与者实施标准化的PT方案。在第一个下 目的，功能评估主要使用五次坐立，患者报告的结果使用 PROMIS-身体机能调查。主要时间点包括手术前和手术结束后10周 康复时间：术后30天、6个月和1年。对于第二个目标，我们 努力通过测量来评估基于登记的随机对照试验设计和术后物理治疗的可行性。 保留率和合规率。对于第三个目标，我们将使用我们的新的定量的、连续的腹部核心 主要和中间时间点的功能评估(Quest)，以帮助确定哪些人可能受益 大部分来自术后PT。提出的这项研究是创新的，因为它打破了专业知识和 检查了结构。它利用了不同外科和医学领域的不同和互补的观点 全面推进康复专科建设。这一贡献预计将是重大的，因为它将导致 强大的、决定性的多中心临床试验，以减轻腹股沟腹股沟的医疗和社会负担 美国人口。