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

NCT ID: NCT05286515

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-29

Study Completion Date

2023-06-02

Brief Summary

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

Detailed Description

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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.

Conditions

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Total Joint Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hybrid Preoperative Physical Therapy (PT)

Group Type EXPERIMENTAL

Hybrid Peroperative PT

Intervention Type 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.

Control Standard Physical Therapy (PT)

Group Type ACTIVE_COMPARATOR

Standard Clinical Practice PT

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Campello, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Occupational & Industrial Orthopaedic Center (OIOC)

New York, New York, United States

Site Status

NYU Langone Orthopedic Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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21-01331

Identifier Type: -

Identifier Source: org_study_id

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