Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

Wake Forest University (WFU)

Status: Withdrawn

Conditions: ACL Injury

Treatments: Dietary Supplement: Protein (PROT); Other: Control (CONT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03614351

IRB00046590

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Physical Therapy plus Protein Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Protein (PROT)

Physical Therapy Control

Active Comparator group

Description:

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.

Treatment:

Other: Control (CONT)