Effects of HMB Supplementation on Muscle Mass Following ACL Reconstructive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer
研究概览
简要总结
The anterior cruciate ligament (ACL) is a primary stabilizer of the knee, and thus when ACL injury occurs participation in physical activity is compromised. Reconstructive surgery is often necessary to repair the damage which is then followed by a regimen of physical therapy in order to regain full activity. Nutritional intervention after the surgery could help the patient maintain muscle mass during recovery, thus allowing for a quicker return to normal activity.
详细描述
Beta-hydroxy-beta-methylbutyrate (HMB) is a nutritional supplement shown to improve muscle mass with exercise, and also in muscle loss conditions caused by a decrease in physical activity. Participants will be recruited who will undergo reconstructive surgery for a complete ACL tear and will then enter a standard physical therapy program during a six week recovery period. Subjects will receive either HMB or a placebo supplement during the recovery period. Muscle mass will be measured two weeks prior to the surgery and again after the recovery period using an InBody 720 body composition analyzer. Additionally, the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered as a measure of recovery and activity level during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Complete anterior cruciate ligament (ACL) tear
- •Will benefit from ACL reconstructive surgery
- •Are able to participate in the physical therapy program
- •No previous major knee injuries or surgeries
- •No health conditions affecting muscle mass
排除标准
- •Incomplete ACL tear
- •Have multiple or bilateral ligament tears
- •Are unable to participate in the physical therapy program
- •Have had previous major knee injuries or surgeries
- •Have health conditions affecting muscle mass
研究组 & 干预措施
HMB
3 g HMB/day
干预措施: HMB (Dietary Supplement)
Placebo
Placebo administered similar to the active comparator
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Skeletal Muscle Mass by impedance measurement using the InBody 720 body composition analyzer
时间窗: Six Weeks
Measurement of muscle mass will indicate if the active comparator has preserved or increased muscle mass during the post-surgical recovery period.
次要结局
未报告次要终点