The Effect of Plyometric Exercise Intensity on Function & Articular Cartilage Metabolism After ACL Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in International Knee Documentation Committee (IKDC) Subjective Form Score.
研究概览
简要总结
This is a single-center, randomized, double-blind (subject/evaluator)study. Enrolled patients had anterior cruciate ligament (ACL) reconstruction and met criteria for advanced rehabilitation. The study included 8 weeks of advanced rehabilitation consisting of low- or high-intensity plyometric exercise. The objective of the study was to determine the effect of plyometric exercise intensity on knee function and knee cartilage in patients with ACL reconstruction.
详细描述
As part of the study, investigators will insure patients meet the criteria for advanced rehabilitation based on knee motion, pain levels and quadriceps strength.
Participants will be asked to review the informed consent and consent to the study prior to any study procedures. The study will consist of 2 testing sessions and an 8 week intervention (2 visits per week) at the UF&Shands Orthopaedics and Sports Medicine Institute. The testing sessions will include clinical measures of knee impairments, questionnaires, biomechanical analysis and functional performance testing.
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
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •time from injury to ACL reconstruction is no greater than 6 months,
- •pre-injury activity level includes participation in high-demand activities, and
- •meet the criteria for advanced rehabilitation including full active knee extension, active knee flexion within 5 degrees of the contralateral side, pain rating no greater or equal to 1/10 with activities of daily living, and involved side knee extensor strength at least 60% of the contralateral side.
排除标准
- •bilateral knee injury,
- •prior knee ligament injury and/or surgery,
- •concomitant other ligamentous injury > Grade I,
- •meniscal repair performed in conjunction with ACL reconstruction,
- •cartilage repair procedure performed in conjunction with ACL reconstruction,
- •complications during surgery requiring protocol modification, and
- •renal disease.
结局指标
主要结局
Change in International Knee Documentation Committee (IKDC) Subjective Form Score.
时间窗: Baseline (pre-intervention) to 9 weeks (post-intervention)
The IKDC subjective form is a measure of self-reported knee function. It includes items related to symptoms and functional activities. Scores range from 0 to 100 points, and higher scores equal higher function. Responses will be recorded on hard-copy and entered into a spreadsheet to calculate the score. The change will be computed as (post-intervention score minus pre-intervention score).
Change in Urinary Concentrations of the C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
时间窗: Baseline (pre-intervention) to 9 weeks (post-intervention)
CTX-II is a biomarker of Type II collagen degradation. Early morning, second-void urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay and corrected for creatinine concentration, which will also be determined with enzyme-linked immunosorbent assay. Values will be log-transformed. The change in urinary CTX-II concentration will be computed as (post-intervention value minus pre-intervention value).
次要结局
- Change in Vertical Jump Height.(Baseline (pre-intervention) to 9 weeks (post-intervention))
- Change in the Ratio of Urinary CTXII to Serum CPII Concentrations.(Baseline (pre-intervention) to 9 weeks (post-intervention))