Clinical trial NCT04482400: Technology Interventions to Improve Outcomes After Knee Replacement
Official title: Reducing Sedentary Time Using an Innovative mHealth Intervention Among Total Knee Replacement Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Prisma Health-Midlands
First posted: 2020-07-22
Enrollment: 83
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Objectively Measured (Actigraph) Sedentary Behavior at 2 months
timeFrame: 2 months - baseline
measure: Change in Objectively Measured (Actigraph) Sedentary Behavior at 5 months
timeFrame: 5 months - baseline
Secondary outcomes:
measure: Change in Physical Function
timeFrame: 5 months after surgery
measure: Change in WOMAC Pain Subscale
timeFrame: 5 months after surgery
measure: Total physical activity measured by Actigraph accelerometers
timeFrame: 5 months after surgery
measure: Adherence to NEAT!2 calls
timeFrame: 2 months
measure: Adherence to NEAT!2 app
timeFrame: 2 months
measure: Response to NEAT!2 prompts
timeFrame: 2 months
measure: Change in physical function via chair stand test
timeFrame: 5 months after surgery
Other outcomes:
measure: Change in physical function via timed up and go
timeFrame: 5 months after surgery
measure: Change in Knee Symptoms - KOOS pain
timeFrame: 5 months
measure: Change in Knee Symptoms - KOOS symptoms
timeFrame: 2 months
measure: Change in Knee Symptoms - KOOS ADL
timeFrame: 5 months
measure: Change in Knee Symptoms - KOOS sport/rec
timeFrame: 5 months
measure: Change in Knee Symptoms - KOOS QoL
timeFrame: 5 months
measure: Change in knee symptoms via WOMAC
timeFrame: 5 months
measure: Change in sedentary time via activPAL accelerometers
timeFrame: 5 months
measure: Patient Reported outcomes - Mobility - T-Score
timeFrame: 5 months
measure: Patient Reported outcomes - global health - T-Score
timeFrame: 5 months
measure: Patient Reported outcomes - sleep disturbance - T-Score
timeFrame: 5 months
measure: Change in habit strength
timeFrame: 5 months
measure: Change in sedentary time via SIT-Q
timeFrame: 5 months
measure: Weight
timeFrame: 5 months
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Christine Pellegrini, PhD
role: PRINCIPAL_INVESTIGATOR
References: