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

NCT05286515 | Completed

• 1 other identifier: 21-01331
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Total Joint Arthroplasty

Outcome Measures

Primary Outcomes (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).

  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 Outcomes (11)

• Change in Score on Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Intensity - Short Form 3a

  Baseline, Month 2

• 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)

  Baseline, Month 2

• 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)

  Baseline, Month 2

Other Outcomes (3)

• Baseline Score on General Anxiety Disorder Screener (GAD-7)

  Baseline

• Baseline Score on Center for Epidemiologic Studies Depression Scale Revised-10 (CESD-R-10)

  Baseline

• Score on Measuring Patient Satisfaction (MRPS) Scale

  Month 2

Study Arms (2)

Hybrid Preoperative Physical Therapy (PT)

EXPERIMENTAL

Other: Hybrid Peroperative PT

Control Standard Physical Therapy (PT)

ACTIVE COMPARATOR

Other: Standard Clinical Practice PT

Interventions

Hybrid Peroperative PT OTHER

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.

Hybrid Preoperative Physical Therapy (PT)

Standard Clinical Practice PT OTHER

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.

Control Standard Physical Therapy (PT)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Langone Occupational & Industrial Orthopaedic Center (OIOC)

New York, New York, 10014, United States

Location

NYU Langone Orthopedic Center

New York, New York, 10016, United States

Location

Study Officials

• Marco Campello, PT, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 18, 2022
• Study Start: March 29, 2022
• Primary Completion: May 18, 2023
• Study Completion: June 2, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (2)