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

Total Joint Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05286515
• Other study ID #: 21-01331
• Status: Completed
• Phase: N/A
• Start date: March 29, 2022
• Est. completion date: June 2, 2023

Study information

• Verified date: July 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: June 2, 2023
• Est. primary completion date: May 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Total Joint Arthroplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Occupational & Industrial Orthopaedic Center (OIOC)	New York	New York
United States	NYU Langone Orthopedic Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Average Number of Physical Therapy Sessions Since Enrollment in the Study	Self-reported	Month 2
Secondary	Average Number of Times Per Week Participants Had Physical Therapy	Self-reported	Month 2
Secondary	Number of Readmissions	Self-reported hospital readmission for any reason including revision surgery ED visits	Month 5