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Clinical Trials/NCT04482400
NCT04482400
Completed
Not Applicable

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

University of South Carolina1 site in 1 country83 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Arthroplasty
Sponsor
University of South Carolina
Enrollment
83
Locations
1
Primary Endpoint
Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months
Status
Completed
Last Updated
last year

Overview

Brief Summary

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 .

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
October 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christine A Pellegrini, PhD

Assistant Professor

University of South Carolina

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months

Time Frame: 5 months - baseline

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

Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months

Time Frame: 2 months - baseline

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

Secondary Outcomes

  • Change in WOMAC Pain Subscale(5 months after surgery)
  • Total physical activity measured by Actigraph accelerometers(5 months after surgery)
  • Change in physical function via chair stand test(5 months after surgery)
  • Change in Physical Function(5 months after surgery)
  • Adherence to NEAT!2 calls(2 months)
  • Adherence to NEAT!2 app(2 months)
  • Response to NEAT!2 prompts(2 months)

Study Sites (1)

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