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Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

Primary Purpose

ACL Injury

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Protein (PROT)
Control (CONT)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ACL Injury focused on measuring protein, nutritional guidance, ACL surgery

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Physical Therapy plus Protein Supplement

    Physical Therapy Control

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    Percentage of physical therapy visits attended by individuals
    Compliance in physical therapy will be recorded.
    Percentage counseling sessions attended by individuals
    Compliance in attending nutritional counseling sessions will be recorded.

    Secondary Outcome Measures

    Single Leg Hop Test
    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
    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
    Strength in leg flexion and extension, as measured by Biodex machine
    Change in muscle hypertrophy
    depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.

    Full Information

    First Posted
    July 25, 2018
    Last Updated
    July 29, 2021
    Sponsor
    Wake Forest University Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03614351
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    lack of funding to pay for a coordinator and interventionist,
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    ACL Injury
    Keywords
    protein, nutritional guidance, ACL surgery

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Masking Description
    Physical therapy staff will be blinded.
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical Therapy plus Protein Supplement
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Physical Therapy Control
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Protein (PROT)
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control (CONT)
    Intervention Description
    Instructed not to alter their diet based on the app, and to continue to eat as they normally would.
    Primary Outcome Measure Information:
    Title
    Percentage of individuals that complied with treatment/intervention
    Description
    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.
    Time Frame
    up to 6 months
    Title
    Percentage of frequency individuals successfully used the protein tracking app
    Description
    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.
    Time Frame
    up to 6 months
    Title
    Percentage of physical therapy visits attended by individuals
    Description
    Compliance in physical therapy will be recorded.
    Time Frame
    up to 6 months
    Title
    Percentage counseling sessions attended by individuals
    Description
    Compliance in attending nutritional counseling sessions will be recorded.
    Time Frame
    up to 6 months
    Secondary Outcome Measure Information:
    Title
    Single Leg Hop Test
    Description
    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.
    Time Frame
    baseline and up to 6 month
    Title
    Six Meter Timed Hop Test
    Description
    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.
    Time Frame
    baseline and up to 6 month
    Title
    Change in strength in leg flexion and extension
    Description
    Strength in leg flexion and extension, as measured by Biodex machine
    Time Frame
    baseline and up to 6 month
    Title
    Change in muscle hypertrophy
    Description
    depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.
    Time Frame
    baseline and up to 6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gary Miller, Ph.D.
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The IPD will be available for health history, surgery type, clinical outcomes, and length of time in study.
    IPD Sharing Time Frame
    The data will be available once the study is completed for a 12-month period.
    IPD Sharing Access Criteria
    Interested parties should contact the PI- Gary Miller - for access
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    Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

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