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

NCT ID: NCT04294563

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-04-01

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.

Conditions

Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Immediate Intervention Group

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.

Group Type: EXPERIMENTAL

Peanut Protein Powder

Intervention Type: DIETARY_SUPPLEMENT

Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water

Standard Care by Surgeon and Physical Therapist

Intervention Type: OTHER

Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively

Wait-llist Control Group

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.

Group Type: ACTIVE_COMPARATOR

Standard Care by Surgeon and Physical Therapist

Intervention Type: OTHER

Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively

Interventions

Peanut Protein Powder

Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water

Intervention Type: DIETARY_SUPPLEMENT

Standard Care by Surgeon and Physical Therapist

Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Edward Via College of Osteopathic Medicine-Auburn

UNKNOWN

Sponsor Role: collaborator

Jack Hughston Memorial Hospital

UNKNOWN

Sponsor Role: collaborator

Auburn University

OTHER

Sponsor Role: lead

Responsible Party

Andrew Fruge

Assistant Professor and DPD Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randall J Ruark, MD

Role: STUDY_CHAIR

Jack Hughston Memorial Hospital

Locations

Auburn University

Auburn, Alabama, United States

Countries

United States

Other Identifiers

AU 20-104

Identifier Type: -

Identifier Source: org_study_id