A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement

Not Applicable

Completed

Conditions: Physical Activity

Interventions: Behavioral: Standardize PT after TKR with a Physical Activity Intervention
Other: Standardized PT after TKR

Registration Number: NCT03228719

Lead Sponsor: University of Delaware

Brief Summary: 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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 125

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Standardize PT after TKR with a Physical Activity Intervention	Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention
Control Group	Standardized PT after TKR	Standardized Outpatient Physical Therapy after TKR
Intervention Group	Standardized PT after TKR	Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention

Primary Outcome Measures

Name	Time	Method
Physical Activity Measured by an Actigraph GT3X Monitor	Baseline, discharge from PT, and 6 months after PT discharge	Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week

Secondary Outcome Measures