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Withdrawn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
About this trial
This is an interventional supportive care trial for ACL Injury focused on measuring protein, nutritional guidance, ACL surgery
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.
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
NCT ID
NCT03614351
First Posted
July 25, 2018
Last Updated
July 29, 2021
Sponsor
Wake Forest University Health Sciences
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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