The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Percentage of individuals that complied with treatment/intervention
研究概览
简要总结
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Protein supplementation could be useful to improve clinical outcomes.
详细描述
Protein supplementation may promote increases in strength and hypertrophy in the context of resistance training (RT) and reduce markers of inflammation, while sufficient levels of protein are necessary for healing certain wounds and maintenance of muscle mass in a protein depleted state. Despite this, no studies have investigated the role of protein provision in the context of physical therapy (PT) or musculoskeletal rehabilitation, including following surgical interventions. Survey data of Americans in the highest protein consuming age range (19-30 year old consuming 91 g/kg body weight/day), show they have an adequate protein intake to maintain nitrogen balance at baseline (85 g/kg). However, if patients under consume protein, as apparent in older adults (mean intake of 66 g/kg) these individuals will require more during times of tissue healing or could benefit with more in attempting to build back their strength through RT or PT. Thus, protein supplementation could be useful to improve clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Physical therapy staff will be blinded.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with a complete ACL tear and received a hamstring autograft ACL repair surgery (within 8 months of injury) and plan to complete physical therapy and follow up treatment with WFBH at D1 outpatient rehabilitation
- •Subjects must have a smartphone capable of running the nutrition tracking app (My Fitness Pal)
排除标准
- •Subjects must not have other ligamentous involvement, or complications during the surgical procedure.
- •They must not have had a concurrent meniscal repair (debridement is acceptable).
- •They must not have post-operative limitations that interfere with rehabilitation.
- •Patients determined by the referring surgeon to be poor candidates for the study for any medical (including history of eating disorder, phenylketonuria, maple syrup urine disease, food allergies, lactose intolerance, kidney or liver disease) or other reasons that deem them inappropriate to complete the intervention (driving distance from facility, work schedule that prohibits therapy treatments, dietary restrictions) will be excluded.
- •Females who are pregnant will not be permitted in the study.
结局指标
主要结局
Percentage of individuals that complied with treatment/intervention
时间窗: up to 6 months
Compliance among treatment group in meeting 2 g/kg protein goal as measured by protein tracking app and in protein supplements provided will be measured.
Percentage of frequency individuals successfully used the protein tracking app
时间窗: up to 6 months
Compliance in usage of protein tracking app will be recorded. The number of days they logged in and recorded their intake vs. total potential days to provide % value of diet protein compliance.
Percentage of physical therapy visits attended by individuals
时间窗: up to 6 months
Compliance in physical therapy will be recorded.
Percentage counseling sessions attended by individuals
时间窗: up to 6 months
Compliance in attending nutritional counseling sessions will be recorded.
次要结局
- Single Leg Hop Test(baseline and up to 6 month)
- Six Meter Timed Hop Test(baseline and up to 6 month)
- Change in strength in leg flexion and extension(baseline and up to 6 month)
- Change in muscle hypertrophy(baseline and up to 6 month)