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Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03614351
Recruitment Status : Withdrawn (lack of funding to pay for a coordinator and interventionist,)
First Posted : August 3, 2018
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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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.

Condition or disease Intervention/treatment Phase
ACL Injury Dietary Supplement: Protein (PROT) Other: Control (CONT) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Physical therapy staff will be blinded.
Primary Purpose: Supportive Care
Official Title: The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : June 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Physical Therapy plus Protein Supplement
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)
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.
Active Comparator: Physical Therapy Control
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)
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of individuals that complied with treatment/intervention [ Time Frame: 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.

  2. Percentage of frequency individuals successfully used the protein tracking app [ Time Frame: 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.

  3. Percentage of physical therapy visits attended by individuals [ Time Frame: up to 6 months ]
    Compliance in physical therapy will be recorded.

  4. Percentage counseling sessions attended by individuals [ Time Frame: up to 6 months ]
    Compliance in attending nutritional counseling sessions will be recorded.


Secondary Outcome Measures :
  1. Single Leg Hop Test [ Time Frame: 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.

  2. Six Meter Timed Hop Test [ Time Frame: 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.

  3. Change in strength in leg flexion and extension [ Time Frame: baseline and up to 6 month ]
    Strength in leg flexion and extension, as measured by Biodex machine

  4. Change in muscle hypertrophy [ Time Frame: baseline and up to 6 month ]
    depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03614351


Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Gary Miller, Ph.D. Wake Forest University Health Sciences
More Information
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Publications:
Cresci GA. Nutrition Support for the Critically Ill Patient: A Guide to Practice. Boca Raton, FL. CRC Press, 2005.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03614351    
Other Study ID Numbers: IRB00046590
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD will be available for health history, surgery type, clinical outcomes, and length of time in study.
Supporting Materials: 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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
protein
nutritional guidance
ACL surgery
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries