Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes

NCT06734845 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2024-12-16

No results posted yet for this study

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

Interventions

PROCEDURE

Total Knee Arthroplasty

Total Joint (Knee or Hip) Arthroplasty

PROCEDURE

Total Joint Arthroplasty

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

Sponsors & Collaborators

  • University of Connecticut

    lead OTHER

Principal Investigators

  • Nancy R Rodriguez, PhD · University of Connecticut

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-10-01
Completion
2023-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06734845 on ClinicalTrials.gov