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.

项目概要摘要 本研究旨在评估物理治疗 (PT) 在改善腹疝术后预后方面的潜在作用 长期目标是开发改善核心腹部肌肉功能和修复的疗法。 考虑到腹部核心的相互关联的组成部分，我们的中心假设是，恢复生活质量。 接受特定类型疝气修复术（腹疝修复术）的患者将得到显着改善 康复后的功能能力和生活质量，解决损失和收益的机制 该项目的基本原理是一种新颖的概念模型，可以实现创新。 将腹部核心功能纳入腹壁、下背部、 隔膜和盆底，有助于日常生活活动和生活质量。 将通过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）确定术后物理治疗的功效，以改善功能和 腹疝修补术后患者报告的结果；2) 确定术后物理治疗的可行性 改善接受腹疝修补术的个体的功能和临床结果的治疗；3) 确定基线腹部核心功能是否影响术后物理治疗的效果 这项基于登记的前瞻性随机对照试验将利用腹疝修复后的现有基础设施。 腹部核心健康质量合作组织，是疝气疾病和以下疾病患者的国家登记处 腹壁，收集关键的临床指标以及为此添加的其他功能指标 在第一个研究中，将向随机分组的参与者实施标准化的 PT 方案。 目标、功能主要使用五次坐站来评估，并且使用患者报告的结果 PROMIS-身体功能调查主要时间点包括术前和术后 10 周结束时。 对于第二个目标，我们在术后 30 天、6 个月和 1 年增加了康复时间点。 力争通过测量来评估基于注册的随机对照试验设计和术后物理治疗的可行性 对于第三个目标，我们将使用我们新颖的定量、连续腹部核心。 在主要和中间时间点进行功能评估（QUeST），以帮助识别可能受益的人 大部分来自术后 PT。这项研究具有创新性，因为它打破了专业知识和技术的孤岛。 它利用了来自不同手术和技术的多样化和互补的观点。 预计这一贡献将是重大的，因为它将导致一个全面的康复专业。 强有力的确定性多中心临床试验，以减少腹疝的医疗和社会负担 美国人口。