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Clinical Trials/NCT05286515
NCT05286515
Completed
N/A

A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty

NYU Langone Health2 sites in 1 country4 target enrollmentMarch 29, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Joint Arthroplasty
Sponsor
NYU Langone Health
Enrollment
4
Locations
2
Primary Endpoint
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery.

Detailed Description

Study objectives include: 1) testing the feasibility of a hybrid preoperative physical therapy intervention for physically deconditioned patients undergoing total hip and knee replacement, and 2) observing differences in post-surgical outcomes such as pain, pain interference, function and healthcare utilization, between patients who receive the intervention and those who do not.

Registry
clinicaltrials.gov
Start Date
March 29, 2022
End Date
June 2, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient is above 55 years old, indicated for primary total knee or hip replacement surgery and is deconditioned based on the surgeon's clinical judgement (i.e., Use of walker, limited or staggered gait, difficulty in sit to stand) as recorded in study log.
  • Patient falls below the median score on the HOOS/KOOS JR/PROMIS physical function (\<47.4, \<49.8, ≤ 37 respectively and below the median score on the PROMIS Pain Interference score (≥63).
  • Patient has access to technology to participate in telehealth.

Exclusion Criteria

  • Patient is not ambulatory
  • Patient is scheduled for bilateral arthroplasty or revision arthroplasty.
  • Patient is morbidly obese (BMI \>40).
  • Patient has pre-existing medical condition that is contraindicated for exercise such as unstable cardiomyopathy

Outcomes

Primary Outcomes

Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b

Time Frame: Month 2, Month 5

PROMIS - Pain Interference - Short Form 6b measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional physical, and recreational activities. Pain Interference items utilize a 7-day recall period ("the past 7 days"). PROMIS - PI - Short Form 6b consists of 6 items. Each question is scored between 1 to 5. The total score range is 6-30; the higher the score the more of the concept is being measured (more pain interference).

Secondary Outcomes

  • Average Number of Physical Therapy Sessions Since Enrollment in the Study(Month 2)
  • Number of Readmissions(Month 5)
  • Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a(Month 2, Month 5)
  • Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)(Month 2, Month 5)
  • Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)(Month 2, Month 5)
  • Average Number of Times Per Week Participants Had Physical Therapy(Month 2)
  • Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)(Month 2, Month 5)

Study Sites (2)

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