Surgery
Conditions
Keywords
total knee arthroplasty, physical rehabilitation, protein supplementation, muscular atrophy, inflammatory cytokines
Brief summary
This randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) is an effective treatment for patients with knee osteoarthritis (OA) accompanied by severe pain and functional limitations. With the success of this treatment and increasing incidence of OA, it has been projected that \ 3.5 million older adults will undergo TKA annually by the year 2030. While TKA is effective for reducing pain and improving health-related quality of life, TKA patients experience significant skeletal muscle atrophy and weakness in the surgical leg following surgery which, long-term, can compromise balance, functional mobility and increase fall risk. Thus, interventions to mitigate muscle atrophy and weakness post-surgery are essential to improving long-term outcomes in patients undergoing TKA. This randomized controlled trial will study the effects of peanut protein supplementation on changes in muscle size and quality in patients undergoing total knee arthroplasty. Patients (n=30) between the ages of 60-75 years scheduled to undergo total knee arthroplasty at the Jack Hughston clinic/hospital will be recruited to participate. Participants will be stratified by gender and randomized to a peanut protein (PP) supplementation (72g daily, n=15) or waitlist control (standard care with no PP, n=15) group who will be provided with PP following the intervention. Participants in the PP group will consume PP daily starting 7 days prior to surgery and for 6 weeks post-surgery. Participants will be monitored for changes in muscle size and quality (peripheral quantitative computed tomography), upper-leg strength (isokinetic dynamometry), knee range of motion (ROM; goniometry), pain (questionnaire and pressure algometry), and functional mobility outcomes (questionnaire, timed up and go, 2-min walk test) prior to surgery and at 6 and 12-weeks post-surgery.
Interventions
DIETARY_SUPPLEMENTPeanut Protein Powder
Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
OTHERStandard Care by Surgeon and Physical Therapist
Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively
Sponsors
Edward Via College of Osteopathic Medicine-Auburn
Jack Hughston Memorial Hospital
Auburn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* total knee arthroplasty scheduled within two weeks under the care of surgeons at the Jack Hughston Clinic
Exclusion criteria
* history of invasive lower extremity surgery within the last 5 years * allergy to peanuts or peanut products * Body Mass Index \<20 or \>35 kg/m2 * currently adhering to a restrictive weight loss diet * current or recent (within the last 2 months) steroid use * any physical condition that interferes with performing post-surgery rehabilitation * known peripheral vascular disease, kidney disease, liver disease, or uncontrolled endocrine disorder * known overt cardiovascular or metabolic such as heart disease/failure or diabetes * Radiation exposure within the last 6 months other than dental x-rays or associated with current knee treatment/diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mid-thigh skeletal muscle area | 0-6 weeks, 6-12 weeks | peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for total muscle cross-sectional area |
| Change in mid-thigh skeletal muscle area and quality | 0-6 weeks, 6-12 weeks | peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for overall muscle density |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Performance testing | 0-6 weeks, 6-12 weeks | 2 minute walk test |
| Change in leg extensor isokinetic dynamometry | 0-6 weeks, 6-12 weeks | maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex) |
| Change in inflammatory biomarkers | 0-6 weeks, 6-12 weeks | serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine |
| Oxford Knee Score | 0-6 weeks, 6-12 weeks | 12 question inventory |
| Physical Function testing | 0-6 weeks, 6-12 weeks | 3 meter up and go test |
Countries
United States
Outcome results
None listed