RECRUITING

Protein Supplementation After ACL Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to assess the longitudinal post-operative care effects of protein supplementation on muscle atrophy in the post-operative period following ACL reconstruction. The main outcome will be muscle size/mass as measured using dual energy x-ray absorptiometry (DEXA) scanning. The primary objective is to assess for any beneficial impact of protein supplementation, with implications of standardizing a recommended protocol for protein supplementation after ACL reconstruction. Secondary outcomes will be to evaluate the survey data from the KOOS JR and Tampa Scale surveys, as well as functional measures recorded during physical therapy.

Official Title

The Effect of Protein Supplementation on Muscle Atrophy After ACL Reconstruction

Quick Facts

Study Start:2024-02-16
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06311058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:16 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subjects will include patients age 16 to 40 undergoing primary ACL reconstruction for an acute ACL tear with the PI or Sub-investigators
  1. * Subjects will not be included if they meet one of the following criteria
  2. * History of meniscectomy or meniscus repair
  3. * Obesity (BMI\>35)
  4. * Diabetes
  5. * Cardiovascular, renal, liver or pulmonary disease
  6. * Active infections
  7. * Cancer (current or treated within the past 2 years) or coagulation disorder
  8. * Rapid weight change within the past year
  9. * Physically unable to participate in the intervention
  10. * Are currently taking, or recently (w/in 1 month of participation) taken prescribed, or over the counter ergogenic aids or compounds known to be banned by the NCAA.
  11. * Less than 16 years of age
  12. * Vegan patients
  13. * Patient over the age of 40
  14. * Pregnancy ( As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)
  15. * Any known or diagnosed kidney, GI, or liver disorders
  16. * Taking any medications known to affect protein metabolism. This includes, but is not limited to any drugs involved in hormone replacement therapy to treat conditions such as:
  17. * Hypothyroidism: example - levothyroxine
  18. * Hypogonadism: example - exogenous testosterone, estrogen, or any other forms of androgenic or anabolic hormone compounds
  19. * Growth hormone or growth hormone analogues
  20. * Type I or Type II diabetes requiring insulin
  21. * Currently taking protein supplements, amino acid supplements, or any known ergogenic aids.
  22. * Notably, all patients would need to confirm they will be doing their rehab through Houston Methodist
  23. * Patients diagnosed with protein intolerance or digestive issues associated with consuming protein

Contacts and Locations

Study Contact

Haley Goble, MHA
CONTACT
7134413930
hmgoble@houstonmethodist.org

Study Locations (Sites)

Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-16
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-02-16
Study Completion Date2027-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • ACL Reconstruction