Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Peanut Protein Supplementation to Prevent Muscle Atrophy and Improve Recovery Following Total Knee Arthroplasty

Conditions
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Surgery

Intervention / Treatment
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* Dietary Supplement: Peanut Protein Powder
* Other: Standard Care by Surgeon and Physical Therapist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Intervention Group<br>Participants will complete baseline measures and begin daily supplementation of peanut protein powder (72g/day) 7 days prior to total knee arthroplasty until 6 weeks after surgery. | Dietary Supplement: Peanut Protein Powder<br>* Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water<br>Other: Standard Care by Surgeon and Physical Therapist<br>* Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively<br>|
| Active Comparator: Wait-llist Control Group<br>Participants will complete baseline measures 7 days prior to total knee arthroplasty and will receive a 7 week supply after completion of 12 week post-surgery visit. | Other: Standard Care by Surgeon and Physical Therapist<br>* Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mid-thigh skeletal muscle area | peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for total muscle cross-sectional area | 0-6 weeks, 6-12 weeks | 
| Change in mid-thigh skeletal muscle area and quality | peripheral quantitative computed tomography (pQCT) cross-sectional image of mid-right thigh assessed for overall muscle density | 0-6 weeks, 6-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in leg extensor isokinetic dynamometry | maximal isokinetic right leg extensions on an isokinetic dynamometer (BioDex) | 0-6 weeks, 6-12 weeks | 
| Physical Function testing | 3 meter up and go test | 0-6 weeks, 6-12 weeks | 
| Physical Performance testing | 2 minute walk test | 0-6 weeks, 6-12 weeks | 
| Oxford Knee Score | 12 question inventory | 0-6 weeks, 6-12 weeks | 
| Change in inflammatory biomarkers | serum C-reactive protein, interleukin-6, tumor necrosis factor-alpha, plasma 8-hydroxy-2'deoxyguanosine | 0-6 weeks, 6-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, physical rehabilitation, protein supplementation, muscular atrophy, inflammatory cytokines