Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes

Completed

Conditions studied: Orthopedic, Osteo Arthritis Knee, Hip Osteoarthritis, Protein-Energy Malnutrition, Energy Malnutrition Protein

In brief

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.

Key facts

Study ID

NCT06734845

Run by

University of Connecticut

People needed

38

Starts

2023-01-10

Expected to finish

2023-10-01

Last updated by the study team

2024-12-16

Who can join

Age: 50 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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
• Post-enrollment exclusion criteria (if applicable)
• 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).

Where it is running

• Hartford Hospital Bone & Joint Institute — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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