Clinical trial NCT03614351: Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery
Official title: The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: ACL Injury
Keywords: protein
nutritional guidance
ACL surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of individuals that complied with treatment/intervention
timeFrame: up to 6 months
measure: Percentage of frequency individuals successfully used the protein tracking app
timeFrame: up to 6 months
measure: Percentage of physical therapy visits attended by individuals
timeFrame: up to 6 months
measure: Percentage counseling sessions attended by individuals
timeFrame: up to 6 months
Secondary outcomes:
measure: Single Leg Hop Test
timeFrame: baseline and up to 6 month
measure: Six Meter Timed Hop Test
timeFrame: baseline and up to 6 month
measure: Change in strength in leg flexion and extension
timeFrame: baseline and up to 6 month
measure: Change in muscle hypertrophy
timeFrame: baseline and up to 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gary Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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