Improving Physical Activity and Gait Symmetry After Total Knee Arthroplasty

NCT04090125 | Completed Results DMC

• 2 other identifiers: 19-0568R21AR074149-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Replacement, Total; Knee Arthroplasty, Total

Keywords

knee; total knee replacement; physical therapy

Outcome Measures

Primary Outcomes (4)

• Change From Baseline to Month 3 in Objectively Assessed Physical Activity (Accelerometer)

  Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.

  Baseline, Month 3

• Change From Baseline to Month 6 in Objectively Assessed Physical Activity (Accelerometer)

  Minutes of moderate to vigorous intensity PA (MVPA) per week measured via accelerometer. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.

  Baseline, Month 6

• Change From Baseline to Month 3 in Peak Joint Load Symmetry During Walking

  Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.

  Baseline, Month 3

• Change From Baseline to Month 6 in Peak Joint Load Symmetry During Walking

  Participants will complete a 10 meter walking test while load beneath each foot is recorded using an instrumented insole. Loading symmetry (peak ground reaction force) will be assessed using the limb symmetry index (LSI (\|Surgical/Non-Surgical\|\*100), values lower than 100% indicate less loading of the surgical limb. A log transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here.

  Baseline, Month 6

Secondary Outcomes (16)

• Change From Baseline to Month 3 in Self-Reported Physical Activity.

  Baseline, Month 3

• Change From Baseline Month 6 in Self-Reported Physical Activity.

  Baseline to Month 6

• Change From Baseline to Month 3 in Steps Per Day

  Baseline, Month 3

• Change From Baseline to Month 6 in Steps Per Day

  Baseline, Month 6

• Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA)

  Baseline, Month 3

Study Arms (2)

Physical Activity and Symmetry (PAS) Intervention

EXPERIMENTAL

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.

Behavioral: PAS Intervention

Attention Control

PLACEBO COMPARATOR

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

Behavioral: Attention Control

Interventions

PAS Intervention 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).

Physical Activity and Symmetry (PAS) Intervention

Attention Control 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.

Attention Control

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UNC Thurston Arthritis Research Center

Chapel Hill, North Carolina, 27599, United States

Location

Results Point of Contact

• Title: Kelli Allen, PhD
• Organization: University of North Carolina at Chapel Hill

kdallen@email.unc.edu

919-966-0558

Study Officials

• Kelli D Allen, PhD

  University of North Carolina, Chapel Hill

  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: SPONSOR

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: November 8, 2019
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will become available following publication of primary and secondary outcomes, and data will be available until the study is closed with the local IRB.
• Access Criteria: Data will be accessible following publication of study results and will be available until the study is closed with the local IRB.

Locations

US (1)