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

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

Study Overview

• Status: Completed
• Conditions: Total Joint Arthroplasty
• Intervention / Treatment: Other: Hybrid Peroperative PT; Other: Standard Clinical Practice PT

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Campello, PT, PhD; Phone Number: 212-255-6690; Email: Marco.campello@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10014
      • NYU Langone Occupational & Industrial Orthopaedic Center (OIOC)
    • New York, New York, United States, 10016
      • NYU Langone Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid Preoperative Physical Therapy (PT)	Other: Hybrid Peroperative PT; The intervention will consist of an in-person evaluation assessing the subject's functional level, lower and upper extremities range of motion, strength and endurance. The remaining sessions will be conducted via telehealth. The program will consist of two sessions per week up to six weeks. The program will start approximately 8 to 7 weeks before the scheduled surgery date.
Active Comparator: Control Standard Physical Therapy (PT)	Other: Standard Clinical Practice PT; This group will follow the protocols established by the PT facility they chose. They will finish treatment two to three weeks before the surgery date, similar to the intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b	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).	Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference - Short Form 6b	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).	Month 2, Month 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a	PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.	Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a	PROMIS - Pain Intensity - Short Form 3a consists of 3 questions -- participants report on the intensity of pain experienced in the past 7 days. Each question is scored between 1 (had no pain) to 5 (very severe). The total score range is 3-15; the higher the score, the more intense the pain.	Month 2, Month 5
Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)	PROMIS-PF-10 consists of 10 items. Item-levels are scored numerically for an individual's response to each question. The total score range is 10-100; higher scores mean more of a concept being measured (e.g., more fatigue).	Baseline, Month 2
Change in Score on Patient-Reported Outcomes Measurement Information System - Physical Function - 10 (PROMIS-PF-10)	PROMIS-PF-10 consists of 10 items. Item-levels are scored numerically for an individual's response to each question. The total score range is 10-100; higher scores mean more of a concept being measured (e.g., more fatigue).	Month 2, Month 5
Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)	HOOS, JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.	Baseline, Month 2
Change in Hip Disability and Osteoarthritis Outcome Score for Joint Replacement (HOOS, JR)	HOOS, JR contains 6 items from the original HOOS survey. Items are coded from 0 to 4, none to extreme, respectively. HOOS, JR is scored by summing the raw response (range 0-24) and then converting it to an interval score. The interval score ranges from 0-100, where 0 represents total hip disability and 100 represents perfect hip health.	Month 2, Month 5
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)	KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.	Baseline, Month 2
Change in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR)	KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.	Month 2, Month 5
Average Number of Physical Therapy Sessions Since Enrollment in the Study	Self-reported	Month 2
Average Number of Times Per Week Participants Had Physical Therapy	Self-reported	Month 2
Number of Readmissions	Self-reported hospital readmission for any reason including revision surgery ED visits	Month 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Score on General Anxiety Disorder Screener (GAD-7)	GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.	Baseline
Baseline Score on Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)	CED-R-10 is a self-report measure of depression consisting of 10 items. The total score is calculated by finding the sum of the items with a range of 0-30. The higher the score, the greater the depression. Any score equal to or above 10 is considered depressed.	Baseline
Score on Measuring Patient Satisfaction (MRPS) Scale	MRPS consists of 8 items. The rating scale of each item goes from 1 to 5 where 1 is 'strongly disagree' and 5 is 'strongly agree.' The score is calculated as the sum of the item scores with a total score range of 8-40; where a higher score represents higher satisfaction.	Month 2

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Marco Campello, PT, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2022
• Primary Completion (Actual): May 18, 2023
• Study Completion (Actual): June 2, 2023

Study Registration Dates

• First Submitted: March 9, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 17, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-01331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Marco.Campello@nyulangone.org to gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No