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NCT06734845 · ClinicalTrials.gov registry record
Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes
A clinical trial, sponsored by University of Connecticut.
- Completed
- Registry status
- 38
- Enrollment target
NCT06734845: Completed study, sponsored by University of Connecticut.
NCT06734845 is a clinical trial that has completed, run by University of Connecticut. The registered enrollment target is 38 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06734845 has completed, sponsored by University of Connecticut.
- COMPLETED
- Registry status
- 38 participants
- Enrollment target
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.
Primary Outcome
Protein intake will be determined inadequate (less than 1.2 g/kg/day) or adequate (greater than or equal to 1.2g/kg/day)
Interventions
- PROCEDURE Total Knee Arthroplasty
- PROCEDURE Total Joint Arthroplasty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2023-10-01 |
What the finished NCT06734845 record still lists
NCT06734845 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 38 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Total Knee Arthroplasty is the first listed.
NCT06734845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06734845 about?
NCT06734845 is a clinical study titled "Energy Status and Protein Intake As Prognostic Indicators of Rehabilitative Outcomes". 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 e...
What is the current status of trial NCT06734845?
This trial is currently completed. The enrollment target is 38 participants. The study started on 2023-01-10. Estimated completion is 2023-10-01.
What interventions are being tested in trial NCT06734845?
The interventions under investigation include: Total Knee Arthroplasty (PROCEDURE), Total Joint Arthroplasty (PROCEDURE).
Who is sponsoring clinical trial NCT06734845?
This trial is sponsored by University of Connecticut, which has 107 total clinical trials registered on ClinicalTrials.gov.
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