The Effect of Various Strength Training Protocols in ACL Reconstructed Participants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 4
- 主要终点
- Measure Change in Isometric Peak Torque Quadriceps Strength
研究概览
简要总结
The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working.
There will be no charge to the participant for their physical therapy visits as long as they are part of the study
The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires).
The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form.
The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling.
详细描述
The following procedures may be performed.
Training sessions: Participants will be randomly assigned one of two groups. Assignments to which group are determined by random assignment based upon participant's number. One group will receive standard of care and the other will receive standard of care plus blood flow restriction training.
The air bands will then be placed on the participant's thighs and they will be doing a standardized exercise program that will vary depending on the stage of rehabilitation they are in and as determined by the study personnel. Participants will also complete a standardized course of physical therapy. Activities in physical therapy may include ice over the knee, range of motion exercises to maintain hip strength and gait training exercises as needed and as the participant's impairments dictate. The investigator will also provide an educational program at regular intervals on the injury and recovery.
Quadriceps strength: Participants will sit in a seated position and a stabilizing strap will be placed around the thigh. A second strap will be placed around the bottom of their lower leg and attached to the isokinetic dynamometer (a muscle strength testing device) which will control movements and apply force at several different speeds and in a isometric mode.
Motion Analysis: Motion analysis will provide a means for evaluating motion of the participant's hip, knee and ankle joints during walking and jogging on the treadmill. Participants will have reflective markers placed on certain landmarks of their legs and lower back to allow the motion analysis system to record their trunk, hip, knee, and ankle movements. Markers will be applied with sticky tape to the skin and if necessary, athletic tape to limit marker movement during activities. A stationary trial will be collected to help the researcher identify anatomical landmarks. Motion data will be collected for 10 seconds every minute. Participants will perform a series of jumps on both legs and on a single leg. In addition participants will be asked to go up and down step.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, outcomes assessors, and the PI will be blinded as to the participant's group assignment.
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ACL tear and no previous ACL reconstruction on either the involved or other limb
排除标准
- •Previous surgeries or conditions that might affect gait
- •Any current condition other than ACL or meniscus injury which might affect gait
- •Unable to provided informed consent
- •Diabetic or have uncontrolled hypertension
- •Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs.
- •Allergic to Betadine or Xylocaine HCL.
- •Taking warfarin/Coumadin, clopidogrel/Plavix, Rivaroxaban/Xarelto, Dabigatran/Pradaxa that may cause excess bleeding.
- •Any implanted medical device
- •A history of deep vein thrombosis, have a family history of deep vein thrombosis, or varicose veins
- •Spinal fusion
- •Inability able to attend regular physical therapy or study visits
- •Injury occurring more than ten weeks prior to study enrollment
- •Not skeletally mature (growth plates not closed)
结局指标
主要结局
Measure Change in Isometric Peak Torque Quadriceps Strength
时间窗: Baseline, and post-surgery (up to 5 months)
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measure Change in Isokinetic Peak Torque Quadriceps Strength
时间窗: Baseline and post-surgery (up to 5 months)
Assessed with a Biodex Multi-Joint System 4 Isokinetic Dynamometer. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
Measure Change in Rate of Torque Development
时间窗: Baseline and post-surgery (up to 5 months)
Isokinetic Dynamometer will be used. The primary analysis may include the comparison of these observations over multiple time points, with a particular interest in whether there are between-group or within-patient differences.
次要结局
- Measure Change in Quadriceps Muscle Morphology - T1Rho Relaxation Time(Baseline, Post-surgery (up to 5 months))
- Measure Change in Quadriceps Muscle Morphology - Physiological Cross-sectional Area (PCSA)(Baseline, Post-surgery (up to 5 months))
- Measure Change in Knee Biomechanics - Peak Knee Flexion(Baseline and post-surgery (up to 5 months))
- Measure Change in Knee Biomechanics - Knee Extensor Moment (KEM)(Baseline and post-surgery (up to 5 months))
研究者
Brian W. Noehren
Principal Investigator
University of Kentucky