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| Name | Class |
|---|---|
| Edward Via College of Osteopathic Medicine-Auburn | UNKNOWN |
| Jack Hughston Memorial Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention Group | Experimental | 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. |
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| Wait-llist Control Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut Protein Powder | Dietary Supplement | Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randall J Ruark, MD | Jack Hughston Memorial Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn University | Auburn | Alabama | 36849 | United States |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| ID | Term |
|---|---|
| D059825 | Physical Therapists |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Standard Care by Surgeon and Physical Therapist | Other | Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively |
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| 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 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |