Dietary Protein Intake and Rehabilitation From Anterior Cruciate Ligament Surgery

ACL Injury Clinical Trial

Official title:

The Effects of Providing Protein and Nutritional Guidance on Healing Times After ACL Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03614351
• Other study ID #: IRB00046590
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: June 2022

Study information

• Verified date: July 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

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.

Other:
• Control (CONT)
Instructed not to alter their diet based on the app, and to continue to eat as they normally would.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

References & Publications (28)

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* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Percentage of physical therapy visits attended by individuals	Compliance in physical therapy will be recorded.	up to 6 months
Primary	Percentage counseling sessions attended by individuals	Compliance in attending nutritional counseling sessions will be recorded.	up to 6 months
Secondary	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.	baseline and up to 6 month
Secondary	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.	baseline and up to 6 month
Secondary	Change in strength in leg flexion and extension	Strength in leg flexion and extension, as measured by Biodex machine	baseline and up to 6 month
Secondary	Change in muscle hypertrophy	depth of vastus medialis as measured at each nutritional advising appointment with counselor via ultrasound and thigh circumference.	baseline and up to 6 month