Investigating the Associations Between Physical Activity, Knee Joint Loading and Joint Health Following Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Ratio of urine concentration of c-telopeptide of type II collagen to serum concentration of c-propeptide of type II procollagen
研究概览
简要总结
The purpose of this study is to investigate the association between time spent in moderate to vigorous physical activity and markers of cartilage metabolism in the years following anterior cruciate ligament reconstruction.
详细描述
Participants attend the laboratory on two or three occasions and wear accelerometers for the 10 days in between the first and second laboratory session. The first laboratory session involves urine sample collection, the completion of questionnaires, blood sample collection, acquisition of cross-sectional images of the thigh and calf, and a whole-body composition scan. The researchers will use the accelerometers at the wrist to measure time spent in moderate to vigorous physical activity, and the accelerometers at the ankle as an analogue for knee joint loading. The second laboratory session will consist of a 30-minute run on an instrumented treadmill (measures force of each step taken) whilst wearing non-invasive reflective markers, electromyography devices, and an accelerometer at the ankle. Participants are also invited to undergo optional repeated blood sampling to measure levels of markers of cartilage production and breakdown during rest and in response to a 30-minute run. If participants volunteer for the optional repeated blood sampling, they will be asked to attend a third laboratory session where blood samples will be taken at 24 hours after the run in the second laboratory session.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-39 years old (i.e., ≥18 and <40 years old)
- •Had an anterior cruciate ligament injury and reconstruction 1-7 years ago (i.e., ≥1 and ≤7 years ago)
- •Can have sustained damage to meniscus or cartilage, or sustained bone bruising when injured anterior cruciate ligament
- •Can participate regardless of the type of reconstruction surgery and if undergone meniscectomy
- •Completed anterior cruciate ligament reconstruction rehabilitation and either a surgeon, doctor or physiotherapist has provided clearance to participate in physical activity
- •Be able to attend the University of Bath within 2 hours of waking
排除标准
- •Had another significant knee injury either before, at the same time, or after the anterior cruciate ligament injury (e.g., if they injured another ligament in their knee or had a fracture or dislocation)
- •Injured the anterior cruciate ligament in both knees (bilateral ACL injury)
- •Have/are experiencing a musculoskeletal, cardiovascular, respiratory, immune, metabolic or neurological disease or disorder
- •Under 18 or over 39 (i.e., ≥40) years of age
- •Body Mass Index ≥40 kg/m²
- •Positive responses to the Physical Activity Readiness Questionnaire (aside from any involved knee joint issues)
结局指标
主要结局
Ratio of urine concentration of c-telopeptide of type II collagen to serum concentration of c-propeptide of type II procollagen
时间窗: Day 1
Urine concentration of c-telopeptide of type II collagen (uCTX-II) is a marker of cartilage degradation. Serum concentration of c-propeptide of type II procollagen (sCP-II) is a marker of cartilage synthesis. The ratio between these two biomarkers as an indicator of knee joint health has previously been validated.
次要结局
- Step count(Day 3-10)
- Subcutaneous adipose tissue area(Day 1)
- Muscle cross-sectional area(Day 1)
- Lean mass index(Day 1)
- Tampa Scale of Kinesiophobia - 11 score(Day 1)
- English Knee Self-Efficacy Scale score(Day 1)
- Serum concentration of hyaluronic acid(Day 11 and 12)
- Urine concentration of c-telopeptide of type II collagen(Day 1)
- Time spent in moderate to vigorous physical activity(Day 3-10)
- Knee joint reaction force(Day 11)
- Muscle density(Day 1)
- Cumulative knee joint reaction force(Days 3-11)
- Knee Injury and Osteoarthritis Outcome Score(Day 1)
- Time spent in lower body resistance training per week(Day 1)
- Serum concentration of c-propeptide of type II procollagen(Day 1)
- Intra-muscular fat content(Day 1)
- Modified Godin Leisure Time Exercise Questionnaire score(Day 1)
- Serum concentration of chondroitin sulphate 846 epitope(Day 11 and 12)
- Fat mass index(Day 1)
研究者
Karl Morgan
Chief Investigator
University of Bath