The PATH Study to Promote Physical Activity After Knee Replacement

Not Applicable

Completed

• Conditions: Knee Arthroplasty
• Interventions: Behavioral: Standard Physical Therapy; Behavioral: Physical therapist discuss aerobic physical activity; Behavioral: Physical activity session

• Registration Number: NCT03768206
• Lead Sponsor: University of South Carolina

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-05
• Study First Posted: 2018-12-07
• Study Start: 2019-01-14
• Primary Completion: 2020-06-15
• Study Completion: 2020-06-15
• Results First Submitted: 2021-06-07
• Results First Submitted QC: 2021-06-28
• Status Verified: 2021-07
• Results First Posted: 2021-07-19
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PATH	Physical therapist discuss aerobic physical activity	PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions.
PATH	Standard Physical Therapy	PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity \& assist with goal setting during therapy sessions.
PATH-12	Standard Physical Therapy	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.
PATH-12	Physical activity session	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Moderate-Vigorous Intensity Physical Activity	12 weeks	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.

Trial Locations

Locations (2)

Palmetto Health- USC Orthopedic Center; 🇺🇸 Columbia, South Carolina, United States

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States