The PATH Study to Promote Physical Activity After Knee Replacement

Study Overview
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Brief Summary
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The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.

Detailed Description
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Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.

Official Title
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Promoting Physical Activity Via Physical Therapist Following Knee Replacement- The PATH Study

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Behavioral: Standard Physical Therapy
* Behavioral: Physical therapist discuss aerobic physical activity
* Behavioral: Physical activity session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 40-79 years of age Have had a knee replacement in the last 2 months Be willing to wear and accelerometer for 7 days during assessments Be English speaking Exclusion Criteria: Have any contraindications to activity Have a mobility limiting comorbidity Have a scheduled surgery within the next 6 months

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PATH<br>PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions. | Behavioral: Standard Physical Therapy<br>* Participants will receive standard outpatient physical therapy that is typical following knee replacement<br>Behavioral: Physical therapist discuss aerobic physical activity<br>* Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.<br>|
| Active Comparator: PATH-12<br>PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. | Behavioral: Standard Physical Therapy<br>* Participants will receive standard outpatient physical therapy that is typical following knee replacement<br>Behavioral: Physical activity session<br>* Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Enrolled | Feasibility will be determined based on the number of participants enrolled vs. the number approached | Baseline | 
| Percentage of Participants Who Complete the 12 Week Assessment | Acceptability will be determined by the percentage of participants completing the 12 week assessment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate-Vigorous Intensity Physical Activity | Total number of minutes of objectively-measured moderate-vigorous intensity (>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee arthroplasty, behavioral intervention, physical activity