Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04090125
Other study ID # 19-0568
Secondary ID R21AR074149-01A1
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2019
Est. completion date July 26, 2023

Study information

Verified date December 2022
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 26, 2023
Est. primary completion date July 26, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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).
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.

Locations

Country Name City State
United States UNC Thurston Arthritis Research Center Chapel Hill North Carolina

Sponsors (2)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 Change From Baseline to Month 3 in Self-Reported Physical Activity. Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents = 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. Baseline, Month 3
Secondary Change From Baseline Month 6 in Self-Reported Physical Activity. Self-Reported Physical Activity will be assessed using the Modified version of the CHAMPS (Community Health Activities Model Program for Seniors) Physical Activity Measure. Data from the questionnaire is used to determine variety, frequency, and minutes per week from physical activity. This outcome pertains to minutes of physical activity of moderate or greater intensity (metabolic equivalents = 3.0). A square root transformation was applied due to superior diagnostics relative to untransformed values in statistical modeling; transformed values are presented here. Baseline to Month 6
Secondary Change From Baseline to Month 3 in Steps Per Day Step counts 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
Secondary Change From Baseline to Month 6 in Steps Per Day Step counts 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
Secondary Change From Baseline to Month 3 in Minutes of Any Physical Activity (PA) Minutes of any PA 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
Secondary Change From Baseline to Month 6 in Minutes of Any Physical Activity (PA) Minutes of any PA 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
Secondary Change From Baseline to Month 3 in Sedentary Minutes Minutes of sedentary activity per day, measured via accelerometer Baseline, Month 3
Secondary Change From Baseline to Month 6 in Sedentary Minutes Minutes of sedentary activity per day, measured via accelerometer Baseline, Month 6
Secondary Change From Baseline to Month 3 in Berg Balance Scale Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility. Baseline, Month 3
Secondary Change From Baseline to Month 6 in Berg Balance Scale Berg Balance Scale includes 14 tests of static and dynamic balance. Each item is scored along a 5-point scale, ranging from 0 to 4. Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56. Lower scores indicate reduced functional mobility. Baseline, Month 6
Secondary Change From Baseline to Month 3 in Brief Balance Evaluation Systems Test Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24). Lower scores indicate higher levels of balance impairment. Baseline, Month 3
Secondary Change From Baseline to Month 6 in Brief Balance Evaluation Systems Test Brief Balance Evaluation Systems includes 8 tasks across 6 domains. Each item is scored: 0-3 points (0 representing severe impairment and 3 representing no balance impairment), score range is 0-24. Lower scores indicate higher levels of balance impairment. Baseline, Month 6
Secondary Change From Baseline to Month 3 in Knee Injury and Osteoarthritis Outcome Score (KOOS) The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 items), Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Baseline, Month 3
Secondary Change From Baseline to Month 6 in Knee Injury and Osteoarthritis Outcome Score (KOOS) The KOOS is a patient-reported outcome measurement instrument, developed to assess the patient's opinion about their knee and associated problems. Five KOOS subscale scores were administered: Pain (9 items), Symptoms (7 it4ems) Function in daily living (17 items), Function in Sport and Recreation (5 items), and knee-related Quality of Life (4 items). All items are scored on 5-point Likert scales. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. Baseline, Month 6
Secondary Change From Baseline to Month 3 in Tampa Scale for Kinesiophobia The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. Baseline, Month 3
Secondary Change From Baseline to Month 6 in Tampa Scale for Kinesiophobia The Tampa Scale of Kinesiophobia is a 17 item scale for assessing fear of movement. The scale specifically assesses activity avoidance due to pain-related fear of movement. All items are measured on a 4-point scale from "strongly agree" to "strongly disagree." A score of 17 is the lowest possible score, and indicates no kinesiophobia or negligible. A score of 68 is the highest possible score and indicates extreme fear of pain with movement. Baseline, Month 6
See also
  Status Clinical Trial Phase
Recruiting NCT04226339 - Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment N/A
Completed NCT03276143 - FactOr XIa inhibiTion for the pRevention of venOus Thromboembolism in Patients Undergoing Total Knee Arthroplasty Phase 2
Completed NCT03308071 - Hypnosis for Symptom Management in Elective Orthopedic Surgery N/A
Recruiting NCT05100706 - Continuous Adductor Canal Block in Outpatient Total Knee Arthroplasty N/A
Recruiting NCT04564729 - Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing N/A
Recruiting NCT03695640 - Effect of Magnesium Sulphate on Analgesia Following Knee Arthroplasty Phase 4
Recruiting NCT05877261 - Cementless Triathlon 5YR Follow-Up
Recruiting NCT05516381 - Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment N/A
Completed NCT04450485 - Surgical Approach in Fast Track Knee Arthroplasty N/A
Recruiting NCT06108063 - Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan Phase 1/Phase 2
Recruiting NCT06389435 - RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques N/A
Completed NCT03898544 - Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA
Completed NCT03492320 - Progression of Health Related Quality of Life of Patients Waiting for Total Knee Arthroplasty
Active, not recruiting NCT02445443 - LEGION Hinge Safety and Efficacy Study
Terminated NCT02830087 - Tourniquet Pressure in Primary Total Knee Arthroplasty N/A
Completed NCT02186587 - iTotal Pilot Study of ConforMIS Custom Total Knee Implant N/A
Completed NCT00711711 - Manual Lymphatic Drainage Following Total Knee Arthroplasty Surgery N/A
Active, not recruiting NCT05788757 - Optetrak Knee System Post Market Clinical Follow-Up
Completed NCT03703206 - The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA) Phase 3
Completed NCT02947321 - Genicular Radiofrequency Ablation Efficacy in Achieving Total Knee Pain Reduction Trial N/A