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.

项目摘要摘要这项研究旨在评估物理疗法（PT）在改善腹侧疝气后的潜在作用维修。长期目标是开发疗法，以改善腹部核心肌肉的功能和考虑到腹部核心相互关联的组件，恢复生活质量。我们的中心假设是接受特定类型的疝气修复，腹性疝修饰的患者将有所改善康复后的功能能力和生活质量，涉及损失和收益的机制腹部核心功能。该项目的理由是一种新颖的概念模型，可以创新编码腹部核心功能作为腹壁的汇总功能的疗法，下背部，隔膜和骨盆底，有助于日常生活和生活质量的活动。中心假设将通过可行性进行标准化后物理治疗的可行性随机对照试验，追求三个具体目的：1）建立术后物理疗法的有效性，以提高功能和腹侧疝修饰后患者报告的结局； 2）确定术后身体的可行性治疗以改善接受腹疝修复的个体的功能和临床结果； 3）确定基线腹部核心功能是否影响术后物理治疗的效率腹性疝修饰后。这种基于注册表的RCT将利用当前的基础架构腹部核心健康质量合作组织，疝气病患者的国家注册表腹壁收集关键的临床措施以及为此添加的其他功能措施学习。标准化的PT协议将用于随机的参与者组。在第一个 AIM，功能主要使用五次坐下来评估，并使用患者报告的结果使用 Promis-Physical功能调查。主时间点包括前OP和OP后10周的结论。康复，在30天，6个月和1年后有额外的时间点。对于第二个目标，我们努力评估基于注册表的RCT设计和术后物理疗法的可行性保留和合规率。对于第三个目标，我们将使用我们的新型定量，连续的腹部核心在初级和中间时间点的功能评估（任务），以帮助确定可能受益的人大多数来自术后PT。提出的研究具有创新性，因为它破坏了专业知识和检查了结构。它利用不同的手术和康复专业以整体方式。预计此贡献将很重要，因为它将导致功能强大的确定性多中心临床试验，以减少腹侧疝的医学和社会伯恩尼亚美国人口。