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Completed

NCT Number: NCT04482400

Technology Interventions to Improve Outcomes After Knee Replacement

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 .

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Key information

Conditions

Knee Arthroplasty

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NEAT!2

Behavioral

8 week sedentary reduction program

MyKneeGuide

Behavioral

8 week surgery recovery education program

Primary outcomes

  1. Objectively Measured (Actigraph) Sedentary Behavior at 2 Months

    Time frame: 2 months

    sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months

  2. Objectively Measured (Actigraph) Sedentary Behavior at 5 Months

    Time frame: 5 months

    sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months

Secondary outcomes

  1. Physical Function

    Time frame: 5 months after surgery

    Six minute walk test - the number of feet an individual can walk in 6 minutes.

  2. WOMAC Pain Subscale

    Time frame: 5 months after surgery

    WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain)

  3. Total Physical Activity Measured by Actigraph Accelerometers

    Time frame: 5 months after surgery

    objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers

  4. Adherence to Calls

    Time frame: 2 months

    Number of calls completed

  5. Adherence to NEAT!2 App

    Time frame: 2 months

    total days NEAT! app was used

  6. Response to NEAT!2 Prompts

    Time frame: 2 months

    percentage of notifications in which a transition from sitting to standing was detected

  7. Physical Function Via Chair Stand Test

    Time frame: 5 months after surgery

    Chair stand test - how many times a participant can stand up and sit down in 30 seconds

Other outcomes

  1. Physical Function Via Timed up and go

    Time frame: 5 months after surgery

    Timed up and go test - How fast a participant can stand up, walk around a cone, and return back to the chair and sit.

  2. Knee Symptoms - KOOS Pain

    Time frame: 5 months

    Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subcale (0 indicates extreme problems, 100 no problems)

  3. Knee Symptoms - KOOS Symptoms

    Time frame: 2 months

    Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms subcale (0 indicates extreme problems, 100 no problems)

  4. Knee Symptoms - KOOS ADL

    Time frame: 5 months

    Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) subscale (0 indicates extreme problems, 100 no problems)

  5. Knee Symptoms - KOOS Sport/Rec

    Time frame: 5 months

    Knee Injury and Osteoarthritis Outcome Score (KOOS) sport/recreation subcale (0 indicates extreme problems, 100 no problems)

  6. Knee Symptoms - KOOS QoL

    Time frame: 5 months

    Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subcale (0 indicates extreme problems, 100 no problems)

  7. Sedentary Time Via activPAL Accelerometers

    Time frame: 5 months

    minutes/day in sedentary time as assessed by activPAL accelerometer worn for 7 days on the thigh

  8. Patient Reported Outcomes - Mobility - T-Score

    Time frame: 5 months

    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)

  9. Patient Reported Outcomes - Global Health - T-Score

    Time frame: 5 months

    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)

  10. Patient Reported Outcomes - Sleep Disturbance - T-Score

    Time frame: 5 months

    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)

  11. Sedentary Time Via SIT-Q

    Time frame: 5 months

    Self-reported sitting time on weekday in hours/day as assessed by the SIT-Q survey

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • Northwestern University
  • Prisma Health-Midlands

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2020
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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