Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes

NCT06734845 | Completed

• 1 other identifier: HHC-2022-0261
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project is novel in its goal to establish a foundation for evidence-based rehabilitative nutrition guidelines to enhance perioperative patient care and improve post-operative rehabilitative outcomes specific to muscle health (muscle mass, strength, and function) and quality of life in elective orthopedic surgery patients undergoing total joint replacement procedures. Study Aims. Specific aims and their respective approach for the proposed investigation were: Aim 1: Characterize energy status and protein intake in total hip arthroplasty and total knee arthroplasty patients prior to surgery. Approach. Following approval of investigation by the Hartford Hospital Institution Review Board, data collection involved the inclusion of a research information sheet and a 3-day food record with instructions for the respective patient to complete prior to surgery. Aim 2: Evaluate association between energy status, positive or negative energy balance on standard outcome measures assessed throughout physical rehabilitation to determine whether energy status and protein intake at admission predicts objective and subjective rehabilitative outcome measures. Dietary assessments (3-day food record, protein screener) occurred at time points corresponding to physical rehabilitative assessments per approach for Aim 1. Approach. Total Hip Replacement assessments will occur between Day 1 following surgery and Week 2 and 6 months post surgery . Outcome measures included Pain Visual Analog Scale, Hip Disability Osteoarthritis Outcome Score, Timed Up and Go Test, 30 second Sit to Stand Test, Passive Hip Range of Motion and Active Hip Range of Motion. Total knee assessments were taken post surgery on between Day 1 and Week 2 and at 4 to 6 Weeks, and 7 to 12 Weeks following surgery. These included Pain Visual Analog Scale, Knee Injury and Osteoarthritis Outcome Score, Timed Up and Go test, 30-second Sit to Stand Test, Passive and Active Knee Range of Motion, and Knee Strength. Aim 3: Validate a protein screener developed by our research team and designed to characterize protein intake and protein source was administered pre- and post-operatively. For the latter, time points were established according to respective treatment guidelines for Total Hip and Total Knee replacement patients, respectively.

Conditions

Orthopedic; Osteo Arthritis Knee; Hip Osteoarthritis; Protein-Energy Malnutrition; Energy Malnutrition Protein

Keywords

Joint replacement; Rehabilitation; Protein; Energy Balance; Knee arthroplasty; Hip arthroplasty; Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Protein Intake

  Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)

  Protein intake will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients

• Protein Intake

  Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)

  Protein intake will be assessed 1-2 weeks before surgery postoperatively between Day 1 to Week 2, at 4 to 6 Weeks, and at 7 to 12 Weeks for total knee arthroplasty patients

Secondary Outcomes (2)

• Energy balance (i.e., positive or negative balance determined as difference between estimates of calorie/energy intake and energy expenditure)

  Energy balance/status will be assessed 1-2 weeks before surgery and postoperatively at day 1, Week 2, and 6 months for total hip arthroplasty patients.

• Energy balance (i.e., positive or negative balance determined as difference between estimates of calorie/energy intake and estimates of energy expenditure)

  Energy balance/status will be assessed 1-2 weeks before surgery postoperatively between Day 1 to Week 2, at 4 to 6 Weeks, and at 7 to 12 Weeks for total knee arthroplasty patients

Study Arms (2)

Total Knee Arthroplasty

Patients undergoing first total knee replacement

Procedure: Total Knee Arthroplasty

Total Hip Arthroplasty

Patients undergoing first total hip replacement

Procedure: Total Joint Arthroplasty

Interventions

Total Knee Arthroplasty PROCEDURE

Total Joint (Knee or Hip) Arthroplasty

Also known as: Total Hip Arthroplasty

Total Knee Arthroplasty

Total Joint Arthroplasty PROCEDURE

Participants will be patients undergoing first total knee or total hip replacement

Total Hip Arthroplasty

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults aged 50-70 yrs undergoing first elective total joint arthroplasty for hip or knee.

You may qualify if:

• Body Mass Index (BMI) between 18.5-34.9 kg/m2; receiving elective total hip or knee arthroplasty due to osteoarthritis for first time

You may not qualify if:

• Patients with any non-orthopedic impairment that can impact lower extremity function or mobility, such as paralysis, stroke, multiple sclerosis, and spinal cord injury
• For Aim 2:
• Patients who do not attend post-operative physical therapy at one of the identified locations (please see section: Project Personnel)
• Patients who are non-compliant with their physical therapy prescription (missing four or more scheduled sessions).

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

Hartford Hospital Bone & Joint Institute

Hartford, Connecticut, 06102, United States

Location

Related Publications (9)

• Mizner RL, Petterson SC, Clements KE, Zeni JA Jr, Irrgang JJ, Snyder-Mackler L. Measuring functional improvement after total knee arthroplasty requires both performance-based and patient-report assessments: a longitudinal analysis of outcomes. J Arthroplasty. 2011 Aug;26(5):728-37. doi: 10.1016/j.arth.2010.06.004. Epub 2010 Sep 20.

  PMID: 20851566 BACKGROUND

• Howard EE, Pasiakos SM, Fussell MA, Rodriguez NR. Skeletal Muscle Disuse Atrophy and the Rehabilitative Role of Protein in Recovery from Musculoskeletal Injury. Adv Nutr. 2020 Jul 1;11(4):989-1001. doi: 10.1093/advances/nmaa015.

  PMID: 32167129 BACKGROUND

• Howard EE, Margolis LM, Fussell MA, Rios CG, Meisterling EM, Lena CJ, Pasiakos SM, Rodriguez NR. Effect of High-Protein Diets on Integrated Myofibrillar Protein Synthesis before Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Pilot Study. Nutrients. 2022 Jan 27;14(3):563. doi: 10.3390/nu14030563.

  PMID: 35276922 BACKGROUND

• Church DD, Schutzler SE, Wolfe RR, Ferrando AA. Perioperative amino acid infusion reestablishes muscle net balance during total hip arthroplasty. Physiol Rep. 2021 Sep;9(18):e15055. doi: 10.14814/phy2.15055.

  PMID: 34558214 BACKGROUND

• Wischmeyer PE, Carli F, Evans DC, Guilbert S, Kozar R, Pryor A, Thiele RH, Everett S, Grocott M, Gan TJ, Shaw AD, Thacker JKM, Miller TE, Hedrick TL, McEvoy MD, Mythen MG, Bergamaschi R, Gupta R, Holubar SD, Senagore AJ, Abola RE, Bennett-Guerrero E, Kent ML, Feldman LS, Fiore JF Jr; Perioperative Quality Initiative (POQI) 2 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Nutrition Screening and Therapy Within a Surgical Enhanced Recovery Pathway. Anesth Analg. 2018 Jun;126(6):1883-1895. doi: 10.1213/ANE.0000000000002743.

  PMID: 29369092 BACKGROUND

• Dreyer HC, Owen EC, Strycker LA, Smolkowski K, Muyskens JB, Kirkpatrick TK, Christie AD, Kuehl KS, Lantz BA, Shah SN, Mohler CG, Jewett BA. Essential Amino Acid Supplementation Mitigates Muscle Atrophy After Total Knee Arthroplasty: A Randomized, Double-Blind, Placebo-Controlled Trial. JB JS Open Access. 2018 Jun 4;3(2):e0006. doi: 10.2106/JBJS.OA.18.00006. eCollection 2018 Jun 28.

  PMID: 30280129 BACKGROUND

• Dreyer HC, Strycker LA, Senesac HA, Hocker AD, Smolkowski K, Shah SN, Jewett BA. Essential amino acid supplementation in patients following total knee arthroplasty. J Clin Invest. 2013 Nov;123(11):4654-66. doi: 10.1172/JCI70160. Epub 2013 Oct 25.

  PMID: 24135139 BACKGROUND

• Kouw IWK, Groen BBL, Smeets JSJ, Kramer IF, van Kranenburg JMX, Nilwik R, Geurts JAP, Ten Broeke RHM, Poeze M, van Loon LJC, Verdijk LB. One Week of Hospitalization Following Elective Hip Surgery Induces Substantial Muscle Atrophy in Older Patients. J Am Med Dir Assoc. 2019 Jan;20(1):35-42. doi: 10.1016/j.jamda.2018.06.018. Epub 2018 Aug 11.

  PMID: 30108034 BACKGROUND

• Dutaillis B, Maniar N, Opar DA, Hickey JT, Timmins RG. Lower Limb Muscle Size after Anterior Cruciate Ligament Injury: A Systematic Review and Meta-Analysis. Sports Med. 2021 Jun;51(6):1209-1226. doi: 10.1007/s40279-020-01419-0. Epub 2021 Jan 25.

  PMID: 33492623 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Protein-Energy Malnutrition; Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Protein Deficiency; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Nancy R Rodriguez, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emerita

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: December 16, 2024
• Study Start: January 10, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 16, 2024

Record last verified: 2024-11

Locations

US (1)