Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

Not Applicable

Withdrawn

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
Physical Therapy plus Protein Supplement	Protein (PROT)	Participants will be randomized to the protein supplementation group, PROT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app.
Physical Therapy Control	Control (CONT)	Participants will be randomized to the enhanced-care control group, CONT, and will receive education from a dietary counselor on how to monitor protein intake using a smartphone app.

Primary Outcome Measures

Name	Time	Method
Percentage of individuals that complied with treatment/intervention	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	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	up to 6 months	Compliance in physical therapy will be recorded.
Percentage counseling sessions attended by individuals	up to 6 months	Compliance in attending nutritional counseling sessions will be recorded.

Secondary Outcome Measures

Name	Time	Method
Single Leg Hop Test	baseline and up to 6 month	Functional healing time based on single leg hop test. The distance the participant hopped on one leg will be recorded and measured in centimeters. This will be done three times and an average will be given.
Six Meter Timed Hop Test	baseline and up to 6 month	Functional healing time based six meter timed hop test. The time it took the participant to hop six meters on foot will be measured and recorded.
Change in strength in leg flexion and extension	baseline and up to 6 month	Strength in leg flexion and extension, as measured by Biodex machine
Change in muscle hypertrophy	baseline and up to 6 month	depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.