Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty

NCT ID: NCT04090125

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-08
• Study Completion Date: 2023-07-26

Brief Summary

The purpose of this pilot study is to examine the effectiveness of the Physical Activity and Symmetry (PAS) program, compared to an attention (ATT)control group, for patients with post-total knee arthroplasty (TKA). The investigators hypothesize that the PAS treatment will result in meaningful improvements in physical activity (PA) and joint loading symmetry compared to the ATT group.

Detailed Description

Background and Significance: Total knee arthroplasty (TKA) has been shown to decrease pain and to improve range of motion and some aspects of physical function. However, accumulating evidence shows that patients have persistent deficits in other critical outcomes following TKA. First, the majority of patients do not substantially increase physical activity beyond levels prior to TKA, remaining well below Department of Health and Human Services recommendations and levels of healthy individuals. This has serious negative implications for both joint health and overall health. Second, studies show that gait asymmetries are common following TKA, such that patients continue to load the non-surgical leg more heavily during walking, even when the post-surgical leg is pain free. This places the contralateral limb at risk for developing or worsening osteoarthritis. Other research shows there is large variability in post-TKA rehabilitation, along with sub-optimal exercise content. Collectively, these findings emphasize the critical need to improve the post-TKA rehabilitation process. However, there are currently no evidence-based approaches to improve overall physical activity and deficits in joint loading symmetry that have been identified following TKA.

Study Aims: This research project will provide important preliminary information on the novel post-TKA PAS program through achieving the following specific aims: 1) Obtain preliminary data on the efficacy of the PAS program with respect to the change in objectively assessed physical activity, measured via accelerometers; 2) Obtain preliminary data on the efficacy of the PAS program with respect to change in peak load symmetry during walking, measured by a novel 3-sensor insole device; 3) Assess the feasibility and acceptability of the PAS program following TKA.

Study Description: Investigators will conduct an exploratory randomized controlled study, with n=60 patients >=18 years receiving post-TKA physical therapy (PT) at a UNC Healthcare System clinic. Patients will be equally allocated to the PAS intervention or an attention (ATT) control group.

Conditions

Knee Replacement, Total; Knee Arthroplasty, Total

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Activity and Symmetry (PAS) Intervention

Participants assigned to the PAS intervention will receive 4 sessions on balance training and physical activity coaching delivered by a physical therapist, in addition to their usual post-TKA physical therapy (PT) care.

Group Type: EXPERIMENTAL

PAS Intervention

Intervention Type: BEHAVIORAL

The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).

Attention Control

Participants assigned to the ATT group will receive usual post-TKA physical therapy (PT) care, followed by two additional sessions with their physical therapist.

Group Type: PLACEBO_COMPARATOR

Attention Control

Intervention Type: BEHAVIORAL

This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.

Interventions

PAS Intervention

The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).

Intervention Type: BEHAVIORAL

Attention Control

This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients receiving post-total knee arthroplasty (TKA) physical therapy (PT) at a University of North Carolina (UNC) Healthcare System clinic

Exclusion Criteria

• significant cognitive impairment
• neurological disorders affecting gait
• systemic rheumatic disease
• hospitalization for a cardiovascular condition the past six months
• psychosis
• substance abuse disorder
• lower extremity surgery in the past year
• any other health conditions determined to be contraindications to a home exercise program

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelli D Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AR074149-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-0568

Identifier Type: -

Identifier Source: org_study_id