Technology Interventions to Improve Outcomes After Knee Replacement

Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients

The purpose of this study is to examine the effects of two technology interventions on health outcomes (e.g., physical activity, sedentary behavior, physical function, pain) after knee replacement at 2 and 5 months .

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Behavioral: NEAT!2; Behavioral: MyKneeGuide

Detailed Description

Two 8 week technology interventions will be examined and consist of the use of an app and/or website and regular calls. Assessments to examine outcomes will be completed at baseline, as well as at 2 and 5 months.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Be 40-79 years of age
• Had unilateral knee replacement within last 12 months
• Have an Android or iOS smartphone that is accessible and near them the majority of the day
• Be willing to download the study applications on their smartphone
• Spend at least 7 hours/day sitting
• Be English speaking

Exclusion Criteria:

• Have any contraindications to activity
• Have a mobility limiting comorbidity
• Have a scheduled surgery within the next 6 months
• Do not have ≥4 days of valid accelerometer (>=10 hours) wear at baseline.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NEAT!2; Participants randomized to this arm will use the NEAT!2 app and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.	Behavioral: NEAT!2; 8 week sedentary reduction program
Active Comparator: MyKneeGuide; Participants randomized to this arm will use the MyKneeGuide app/website and receive biweekly coaching calls for 8 weeks, and monthly maintenance calls between months 2-5.	Behavioral: MyKneeGuide; 8 week surgery recovery education program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objectively Measured (Actigraph) Sedentary Behavior at 2 Months	sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months	2 months
Objectively Measured (Actigraph) Sedentary Behavior at 5 Months	sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months	5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Six minute walk test - the number of feet an individual can walk in 6 minutes.	5 months after surgery
WOMAC Pain Subscale	WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)	5 months after surgery
Total Physical Activity Measured by Actigraph Accelerometers	objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers	5 months after surgery
Adherence to Calls	Number of calls completed	2 months
Adherence to NEAT!2 App	total days NEAT! app was used	2 months
Response to NEAT!2 Prompts	percentage of notifications in which a transition from sitting to standing was detected	2 months
Physical Function Via Chair Stand Test	Chair stand test - how many times a participant can stand up and sit down in 30 seconds	5 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function Via Timed up and go	Timed up and go test - How fast a participant can stand up, walk around a cone, and return back to the chair and sit.	5 months after surgery
Knee Symptoms - KOOS Pain	Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subcale (0 indicates extreme problems, 100 no problems)	5 months
Knee Symptoms - KOOS Symptoms	Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms subcale (0 indicates extreme problems, 100 no problems)	2 months
Knee Symptoms - KOOS ADL	Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) subscale (0 indicates extreme problems, 100 no problems)	5 months
Knee Symptoms - KOOS Sport/Rec	Knee Injury and Osteoarthritis Outcome Score (KOOS) sport/recreation subcale (0 indicates extreme problems, 100 no problems)	5 months
Knee Symptoms - KOOS QoL	Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subcale (0 indicates extreme problems, 100 no problems)	5 months
Sedentary Time Via activPAL Accelerometers	minutes/day in sedentary time as assessed by activPAL accelerometer worn for 7 days on the thigh	5 months
Patient Reported Outcomes - Mobility - T-Score	Patient-Reported Outcomes Measurement Information System (PROMIS) - T score (50 indicates the population mean with a *standard deviation of 10) - (scores higher than 50 represent better function and mobility)	5 months
Patient Reported Outcomes - Global Health - T-Score	Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health - T score (50 indicates the population mean with a standard deviation of 10) (scores higher than 50 represent better health)	5 months
Patient Reported Outcomes - Sleep Disturbance - T-Score	Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep disturbance - T score (50 indicates the population mean with a standard deviation of 10) (scores higher than 50 represent worse sleep disturbance)	5 months
Sedentary Time Via SIT-Q	Self-reported sitting time on weekday in hours/day as assessed by the SIT-Q survey	5 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: Northwestern University; Prisma Health-Midlands
• Investigators: Principal Investigator: Christine Pellegrini, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): October 25, 2024
• Study Completion (Actual): October 25, 2024

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00092132

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data will be made available 12 months after the primary manuscript is published.
• IPD Sharing Time Frame: 12 months after primary manuscripts are published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No