An interventional study of Hybrid Peroperative PT and Standard Clinical Practice PT in Total Joint Arthroplasty, sponsored by NYU Langone Health. Completed at 2 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
This study aims to determine the feasibility of implementing a hybrid physical therapy intervention prior to total joint replacement surgery.
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.
NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.
Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: Hybrid Peroperative PT
Other: Standard Clinical Practice 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.
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.
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).
Time frame: 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).
Time frame: Month 2, Month 5
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 2, Month 5
Average Number of Physical Therapy Sessions Since Enrollment in the Study
Self-reported
Time frame: Month 2
Average Number of Times Per Week Participants Had Physical Therapy
Self-reported
Time frame: Month 2
Number of Readmissions
Self-reported hospital readmission for any reason including revision surgery ED visits
Time frame: Month 5
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.
Time frame: 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.
Time frame: 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.
Time frame: Month 2
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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