Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

NCT03614351 | Withdrawn

• 1 other identifier: IRB00046590
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ACL Injury

Keywords

protein; nutritional guidance; ACL surgery

Outcome Measures

Primary Outcomes (4)

• Percentage of individuals that complied with treatment/intervention

  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.

  up to 6 months

• Percentage of frequency individuals successfully used the protein tracking app

  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.

  up to 6 months

• Percentage of physical therapy visits attended by individuals

  Compliance in physical therapy will be recorded.

  up to 6 months

• Percentage counseling sessions attended by individuals

  Compliance in attending nutritional counseling sessions will be recorded.

  up to 6 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Physical Therapy plus Protein Supplement

EXPERIMENTAL

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.

Dietary Supplement: Protein (PROT)

Physical Therapy Control

ACTIVE COMPARATOR

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.

Other: Control (CONT)

Interventions

Protein (PROT) DIETARY_SUPPLEMENT

Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal.

Physical Therapy plus Protein Supplement

Control (CONT) OTHER

Instructed not to alter their diet based on the app, and to continue to eat as they normally would.

Physical Therapy Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

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MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Proteins

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Gary Miller, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Physical therapy staff will be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 3, 2018
• Study Start: October 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: August 2, 2021

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available once the study is completed for a 12-month period.
• Access Criteria: Interested parties should contact the PI- Gary Miller - for access