Clinical trial NCT05286515: A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty
Official title: A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Joint Arthroplasty
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-18
Enrollment: 4
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
timeFrame: Baseline, Month 2
measure: Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b
timeFrame: Month 2, Month 5
Secondary outcomes:
measure: Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a
timeFrame: Baseline, Month 2
measure: Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a
timeFrame: Month 2, Month 5
measure: Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)
timeFrame: Baseline, Month 2
measure: Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)
timeFrame: Month 2, Month 5
measure: Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
timeFrame: Baseline, Month 2
measure: Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)
timeFrame: Month 2, Month 5
measure: Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Baseline, Month 2
measure: Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)
timeFrame: Month 2, Month 5
measure: Average Number of Physical Therapy Sessions Since Enrollment in the Study
timeFrame: Month 2
measure: Average Number of Times Per Week Participants Had Physical Therapy
timeFrame: Month 2
measure: Number of Readmissions
timeFrame: Month 5
Other outcomes:
measure: Baseline Score on General Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline
measure: Baseline Score on Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)
timeFrame: Baseline
measure: Score on Measuring Patient Satisfaction (MRPS) Scale
timeFrame: Month 2
Locations:
city: New York
country: United States
facility: NYU Langone Occupational & Industrial Orthopaedic Center (OIOC)
state: New York
city: New York
country: United States
facility: NYU Langone Orthopedic Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Marco Campello, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: