A Physical Therapist Administered Physical Activity Intervention After Total Knee Replacement

NCT03228719 | Completed Results DMC

• 1 other identifier: 946165-97
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Keywords

Total Knee Replacement; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Physical Activity Measured by an Actigraph GT3X Monitor

  Time spent in Moderate to Vigorous Physical Activity (MVPA) average minutes/week

  Baseline, discharge from PT, and 6 months after PT discharge

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Standardized Outpatient Physical Therapy after TKR

Other: Standardized PT after TKR

Intervention Group

EXPERIMENTAL

Standardized Outpatient Physical Therapy after TKR with a Physical Activity Intervention

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

Interventions

Standardize PT after TKR with a Physical Activity Intervention BEHAVIORAL

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.

Intervention Group

Standardized PT after TKR OTHER

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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 45
• Seeking outpatient physical therapy for a unilateral TKR

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

Location

Related Publications (1)

• Christiansen MB, Thoma LM, Master H, Schmitt LA, Pohlig R, White DK. A Physical Therapist-Administered Physical Activity Intervention After Total Knee Replacement: Protocol for a Randomized Controlled Trial. Phys Ther. 2018 Jul 1;98(7):578-584. doi: 10.1093/ptj/pzy037.

  PMID: 29608733 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Daniel K. White
• Organization: University of Delaware

dkw@udel.edu

3028317607

Study Officials

• Daniel K White, PT, ScD, MSc

  University of Delaware

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 25, 2017
• Study Start: July 24, 2017
• Primary Completion: October 4, 2021
• Study Completion: April 21, 2022
• Last Updated: May 11, 2025
• Results First Posted: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)