The IMPACT Study: A Randomized Controlled Trial of Individualized Management Post Ventral Hernia Repair (VHR) Utilizing Abdominal Core Therapy for Enhanced Recovery and Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Abdominal Hernia Surgery Quality of Life Questionnaire
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) intervention targeting Abdominal Core Health components in patients recovering from ventral hernia repair. The study focuses on patients aged 18-75 diagnosed with a ventral transverse hernia between 4 cm and 10 cm, scheduled for elective Ventral Hernia Repair (VHR).
The main questions it aims to answer are:
- Will tailored PT significantly improve abdominal core strength, biomechanical stability, and functional mobility compared to usual care at 3-months post-surgery?
- Will tailored PT lead to higher patient-reported quality of life and satisfaction scores, with a lower incidence of post-operative complications such as bowel obstruction and pelvic floor dysfunction over a 1-year follow-up?
- Will tailored PT result in decreased healthcare utilization, leading to overall cost savings or neutrality compared to usual care over the first year after VHR?
Researchers will compare the tailored physical therapy group to a usual care group to see if the tailored intervention leads to significant improvements in clinical efficacy, patient outcomes, and cost-effectiveness.
Participants will:
- Be randomly assigned to either the Usual Care Group or the PT Group.
- If in the Usual Care Group, receive standard post-operative instructions for 12 weeks, including guidance on binder use, safe lifting, and gradual return to activities.
- If in the PT Group, receive foundational post-operative instructions for the first 2 weeks (similar to usual care). Undergo 6 structured and individualized PT sessions over 10 weeks if in the PT Group, with progression based on Oswestry Disability Index (ODI) and Pelvic Floor Distress Inventory-20 (PFDI-20) scores, including Symptom Modulation, Movement Control, Functional Optimization, or Impairment-Based interventions.
Participants undergo data collection at 2 weeks, 12 weeks, and 1 year post-operation, including imaging, functional mobility tests, pain scales, patient-reported outcomes, physical measurements, and tracking of complications and healthcare utilization. Participate in semi-structured interviews after the 12-week assessment to provide qualitative insights into their experiences and perceived barriers/facilitators.
详细描述
The overarching goal of this project is to evaluate the efficacy, safety, and cost-effectiveness of a tailored physical therapy (PT) targeting Abdominal Core Health (ACH) components in patients recovering from ventral hernia repair (VHR). Specifically, we aim to:
Evaluate the clinical efficacy of tailored PT in improving abdominal core strength, biomechanical stability, and functional mobility. Hypothesis: Participants receiving the personalized PT intervention will demonstrate significant improvements in core strength, biomechanical parameters, and functional performance, compared to usual care at 3-months post-surgery. Objectives: 1.1. Measure changes in ultrasound-assessed abdominal muscle thickness (rectus abdominis, oblique and transversus abdominis muscles) and infra-sternal angle from baseline to 3-months post-surgery in both groups. 1.2. Quantify improvements in functional mobility via the 6-minute walk test and 30-second sit-to-stand test at 3-months post-surgery for all participants. 1.3. Compare incidence and severity of movement-related pain using validated pain scales between groups at 3-months.
Assess the impact of the tailored PT program on patient-reported outcomes and clinical complication rates. Hypothesis: Participants undergoing the tailored PT will report higher quality of life and satisfaction scores, with a lower incidence of post-operative complications such as bowel obstruction and pelvic floor dysfunction over a 1-year follow-up. Objectives: 2.1. Collect and compare patient-reported quality of life metrics and satisfaction with recovery scores at 3-months and 1-year post-surgery. 2.2. Track and compare the incidence of common post-VHR complications between groups over a 1-year follow-up period through medical record review and semi-structured interviews.
Elucidate mechanisms underlying post-VHR recovery and validate sensitive clinical measures for individualized treatment. Hypothesis: Changes in core biomechanics will positively associate with improvements in functional mobility and symptom reduction. Furthermore, quantitative measures will serve as reliable tools for monitoring recovery progress and guiding individualized treatment. Objectives: 3.1. Conduct correlation analyses between changes in biomechanical measures (Aim 1) and improvements in functional mobility and patient-reported outcomes (Aim 2) to identify key recovery pathways. 3.2. Evaluate the reliability and responsiveness of novel and existing quantitative measures (e.g., infra-sternal angle, abdominal circumference, pressure pain thresholds) as indicators of recovery progress and predictors of long-term outcomes.
Determine the cost-effectiveness of the personalized PT intervention compared to usual care. Hypothesis: The tailored PT will result in decreased healthcare utilization-fewer rehospitalizations, complications, and medication use over the first year after VHR-leading to overall cost savings or neutrality, supporting its integration into standard post-VHR care. Objectives: 4.1. Quantify and compare healthcare resource utilization (e.g., rehospitalizations, emergency department visits, specialist consultations, medication use) between groups over a 1-year follow-up. 4.2. Perform a comprehensive cost-effectiveness analysis from a healthcare system perspective, integrating direct and indirect costs with patient outcomes, to calculate the incremental cost-utility ratio of the intervention. 4.3. Conduct a qualitative assessment of patient and provider perceptions regarding the barriers and facilitators to intervention adherence and adoption, informing future implementation strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be aged 18-
- •Diagnosed clinically or via objective testing by a surgeon with a ventral transverse hernia >4 cm and <10 cm.
- •Scheduled for elective surgical correction of a non-recurrent, primary or incisional ventral hernia.
- •Independent functional status.
排除标准
- •Individuals currently receiving or who have received PT within the last 30 days.
- •Individuals currently using an assistive device for ambulation.
- •Individuals diagnosed with a neurologic disorder will be excluded.
- •History of or plan for Botox injection or muscle release related to the hernia.
- •Pregnancy
研究组 & 干预措施
PT Group
Initial Protocol (Post-Randomization): Participants will receive foundational instructions like usual care, including:
Binder Use: Guidance on abdominal binder use.
Lifting Precautions: Instruction on safe lifting techniques to protect the healing abdominal wall.
Gradual Return to Activities: Advice on progressively re-engaging in daily activities.
Tailored Physical Therapy Sessions (6 Sessions): Following the initial phase, participants will undergo 6 structured PT sessions. The progression and focus of these sessions will be individualized based on the participant's Oswestry Disability Index (ODI) score and Pelvic Floor Distress Inventory-20 (PFDI-20) score.
干预措施: PT Group (Other)
Usual Care
Protocol: Participants in this group will receive standard post-operative care instructions, which include:
Binder Use: Guidance on the appropriate use of an abdominal binder.
Lifting Precautions: Instruction on safe lifting techniques to protect the healing abdominal wall.
Gradual Return to Activities: Advice on progressively re-engaging in daily activities.
Follow-up: Participants will continue with usual care (no PT intervention) after the initial 12 weeks until the final assessment at Testing Session 2 (12 weeks post-operatively).
干预措施: Usual Care (Other)
结局指标
主要结局
Abdominal Hernia Surgery Quality of Life Questionnaire
时间窗: 2, 12, and 52 weeks.
a validated patient-reported outcome measure assessing the impact of abdominal wall hernias and their repair on various aspects of quality of life. Scores are typically summed 0-100 with higher scores better.
Abdominal Hernia Surgery Quality of Life Questionnaire
时间窗: 2, 12, and 52 weeks.
a validated patient-reported outcome measure assessing the impact of abdominal wall hernias and their repair on various aspects of quality of life. Scores are typically summed 0-100 with higher scores better.
次要结局
- Bowel Obstruction Occurrence Rate(52 weeks.)
- Incidence of Spine/Pelvic Floor Diagnosis(52 weeks.)
- Pain Intensity (SF-MPQ-2)(2, 12, and 52 weeks.)
- Pain Intensity (NPRS)(2, 12, and 52 weeks.)
- PROMIS Pain Interference(2, 12, and 52 weeks.)
- 30-Second Sit-to-Stand Test(2, 12, and 52 weeks.)
- 6-Minute Walk Test (6MWT)(2, 12, and 52 weeks.)
- Infra-sternal Angle(2, 12, and 52 weeks.)
- Abdominal Circumference(2, 12, and 52 weeks.)
- Abdominal Muscle Hypertrophy(2, 12, and 52 weeks.)
- Pressure Pain Threshold(2, 12, and 52 weeks.)
- Two-Point Discrimination(2, 12, and 52 weeks.)
- Bowel Obstruction Occurrence Rate(52 weeks.)
- Incidence of Spine/Pelvic Floor Diagnosis(52 weeks.)
- Pain Intensity (SF-MPQ-2)(2, 12, and 52 weeks.)
- Pain Intensity (NPRS)(2, 12, and 52 weeks.)
- PROMIS Pain Interference(2, 12, and 52 weeks.)
- 30-Second Sit-to-Stand Test(2, 12, and 52 weeks.)
- 6-Minute Walk Test (6MWT)(2, 12, and 52 weeks.)
- Infra-sternal Angle(2, 12, and 52 weeks.)
- Abdominal Circumference(2, 12, and 52 weeks.)
- Abdominal Muscle Hypertrophy(2, 12, and 52 weeks.)
- Pressure Pain Threshold(2, 12, and 52 weeks.)
- Two-Point Discrimination(2, 12, and 52 weeks.)