The PATH Study to Promote Physical Activity After Knee Replacement

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Behavioral: Standard Physical Therapy; Behavioral: Physical therapist discuss aerobic physical activity; Behavioral: Physical activity session

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health- USC Orthopedic Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PATH; 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; Participants will receive standard outpatient physical therapy that is typical following knee replacement; Behavioral: Physical therapist discuss aerobic physical activity; Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.
Active Comparator: PATH-12; 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; Participants will receive standard outpatient physical therapy that is typical following knee replacement; Behavioral: Physical activity session; Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Prisma Health-Midlands

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): June 15, 2020
• Study Completion (Actual): June 15, 2020

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: physical activity; behavioral intervention; knee arthroplasty
• Other Study ID Numbers: Pro00081254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No