Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Change From Baseline in Five Times Sit-to-stand Time
研究概览
简要总结
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will perform assessments of several activities of daily living and complete several surveys detailing their pre-surgical abilities, quality of life, and pain. Immediately after their surgical procedure, patients will be randomized in a single-blind manner (investigator) in a 1:1 ratio to supervised physical therapy (8 weeks, twice weekly) or standard post-surgical precautions. Assessments and surveys will be repeated by the blinded investigator at 30 days, 10 weeks, 6 months, and 1 year after surgery.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ventral hernia
- •Scheduled for elective ventral hernia repair
- •Independent functional status
- •Transverse hernia width of 2cm or greater
排除标准
- •Previously diagnosed movement or balance disorder
- •Use of ambulatory assistive device (walker or cane)
- •Not currently undergoing or planning to undergo physical therapy or other skilled exercise intervention supervised by a medical rehabilitation professional
研究组 & 干预措施
Standard Post-operative Instructions
Participants in the control group will be told upon post-operative discharge that they should follow the post-operative instructions.
干预措施: Post-operative Precautions (Other)
Supervised Physical Therapy
Participants in the physical therapy group will be scheduled for visits to the physical therapy clinic beginning two weeks after surgery, and will undergo supervised physical therapy treatments approximately twice per week for eight weeks according to a standardized evidence-based post-operative abdominal core surgery rehabilitation program.
干预措施: Supervised Physical Therapy (Other)
结局指标
主要结局
Change From Baseline in Five Times Sit-to-stand Time
时间窗: Baseline before surgery, 10 weeks after surgery
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible. The test is scored in seconds, where a shorter time represents greater mobility.
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
时间窗: Baseline before surgery, 10 weeks after surgery
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function. The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual. Higher scores indicate greater physical function. This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
Change From Baseline in Quiet Unstable Sitting Test
时间窗: Baseline before surgery, 10 weeks after surgery
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome. The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds. QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population. A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population. A positive change indicates improvement in core stability, with an MCID for change ≥1. The total range of the measure can be as high as 0 and has no explicit negative bound.
次要结局
- Change in Hernia Related Quality of Life Survey From Baseline(baseline before surgery, 10 weeks after surgery)
- Change in Timed Up-And-Go Time From Baseline(baseline before surgery, 10 weeks after surgery)
- Change From Baseline in International Physical Activity Questionnaire - Short Form(baseline before surgery, 10 weeks after surgery)
- Change From Baseline in Tampa Scale of Kinesiophobia - Short Form(baseline before surgery, 10 weeks after surgery)
- Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory(1 year after surgery)
- Change in Hernia Related Quality of Life Survey From Baseline(baseline before surgery, 1 year after surgery)
- Change in Timed Up-And-Go Time From Baseline(baseline before surgery, 1 year after surgery)
- Change From Baseline in International Physical Activity Questionnaire - Long Form(baseline before surgery, 1 year after surgery)
- Change From Baseline in Tampa Scale of Kinesiophobia - Short Form(baseline before surgery, 1 year after surgery)
- Change From Baseline in Five Times Sit-to-stand Time(baseline before surgery, 1 year after surgery)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function(baseline before surgery, 1 year after surgery)
- Change From Baseline in Quiet Unstable Sitting Test(baseline before surgery, 1 year after surgery)
研究者
Ajit Chaudhari
Professor
Ohio State University