A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement

Study Overview
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Brief Summary
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Background: The definitive treatment for knee osteoarthritis is Total Knee Replacement (TKR), which results in clinically meaningful improvements in pain and physical function. However, evidence suggests that physical activity remains unchanged after TKR. This randomized clinical trial is investigating the efficacy, fidelity, and safety of a physical therapist administered physical activity intervention for people after TKR. Methods/Design: One hundred and twenty-five individuals, over the age of 45, who seek outpatient Physical Therapy (PT) following a unilateral TKR will be randomized into a control and intervention group. The intervention group will receive a weekly physical activity intervention during PT, which includes a FitbitTM monitor, individualized step goals, and face-to-face feedback provided by the physical therapist. Efficacy of the intervention will be measured by minutes/week spent in Moderate-to-Vigorous Physical Activity (MPVA) using an Actigraph GT3X monitor from enrollment to discharge, 6 months and 12 months from discharge from PT. The association of self-efficacy for exercise and kinesiophobia with physical activity will also be measured at the same time points. Fidelity and safety of the intervention will be assessed during outpatient PT. Discussion: This study is designed to fill a critical clinical need to increase physical activity after TKR. The primary objective of the study is to evaluate the efficacy of a physical therapist administered physical activity intervention for people after TKR. The secondary objectives are to evaluate the fidelity and safety of a physical therapist administered physical activity intervention for people after TKR and to investigate changes in self-reported and performance-based physical function after a physical therapist administered physical activity intervention for people after TKR. The tertiary objective is to explore the association of psychosocial factors with physical activity 6 and 12 months after discharge from a physical therapist administered physical activity intervention for people after TKR. The findings will be used to support a large multi-site clinical trial to test the effectiveness, implementation, and cost of this intervention.

Official Title
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A Novel Physical Therapy Administered Physical Activity Intervention After TKR: A Randomized Control Trial

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Standardize PT after TKR with a Physical Activity Intervention
* Other: Standardized PT after TKR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over the age of 45 Seeking outpatient physical therapy for a unilateral TKR Exclusion Criteria: Not interested in increasing physical activity Any other medical conditions that limit your physical activity Have had or are planning on having another leg surgery within 6 months that is unrelated to your TKR surgery Previously enrolled in a physical activity intervention study at this clinic

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Standardized Outpatient Physical Therapy after TKR | Other: Standardized PT after TKR<br>* Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.<br>|
| Experimental: Intervention Group<br>Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention | Behavioral: Standardize PT after TKR with a Physical Activity Intervention<br>* Standardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT.<br>Other: Standardized PT after TKR<br>* Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity measured by an Actigraph GT3X Monitor | Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week. Hypothesize intervention group will spend 30 minutes or more in MVPA minutes/week than the control group and each of the follow-up time points | Change from baseline physical activity (initial PT evaluation), to discharge from PT (proximately 6-8 weeks after starting PT), to 6 months from PT discharge and to 12 months from PT discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fidelity of the Physical Activity Intervention | Intervention fidelity will measure the adherence of implementing the physical activity intervention in PT practice. This will be measured by reviewing the participant's home exercise program. We will check if the physical therapist documented that they reviewed the participant's physical activity using the FitbitTM and to see if they reviewed the individualized step goal with the participant in the home exercise program log. | At enrollment (initial physical therapy evaluation) to discharge from physical therapy (proximately 6-8 weeks after starting physical therapy) | 
| Safety of the Physical Activity Intervention | Safety will be measured by documenting Adverse Events (AE). An AE is defined as any unfavorable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention. In the case of a major AE the principal investigator (PI) and the University of Delaware Internal Review Board (IRB) will be notified immediately. Pre-enrollment AEs will not be included in the safety assessment. | AE that occur from enrollment to 12-months will document the safety of the intervention. | 
| Self-Reported Physical Function on the Knee Outcome Survey | Self-reported physical function will be measured on the Knee Outcome Survey (KOS). These measures will be collected via medical chart review by a research assistant. | At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy), | 
| Self-Reported Physical Function on the Physical Component Summary of the Short Form Survey SF-36 | Self-reported physical function will be measured Physical Component Summary of the Short Form Survey SF-36. These measures will be collected via medical chart review by a research assistant. | At enrollment (initial physical therapy evaluation), 6 months from discharging from PT, and 12 months from discharging from PT | 
| Objective Measure of Physical Function on the 6 Minute Walk Test | Objective physical function will be measured using walking endurance on the 6 minute walk test (6MWT). These measures will be collected via medical chart review by a research assistant. | At enrollment (initial physical therapy evaluation) and discharge from physical therapy (proximately 6-8 weeks after starting physical therapy), | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Physical Therapy