Knee Arthroplasty
Conditions
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.
Interventions
BEHAVIORALNEAT!2
8 week sedentary reduction program
BEHAVIORALMyKneeGuide
8 week surgery recovery education program
Sponsors
University of South Carolina
Northwestern University
Prisma Health-Midlands
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objectively Measured (Actigraph) Sedentary Behavior at 2 Months | 2 months | sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months |
| Objectively Measured (Actigraph) Sedentary Behavior at 5 Months | 5 months | sedentary behavior (\<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Function | 5 months after surgery | Six minute walk test - the number of feet an individual can walk in 6 minutes. |
| WOMAC Pain Subscale | 5 months after surgery | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) |
| Total Physical Activity Measured by Actigraph Accelerometers | 5 months after surgery | objectively measured light, moderate and vigorous activity (\>= 100 counts/min) by Actigraph accelerometers |
| Adherence to Calls | 2 months | Number of calls completed |
| Adherence to NEAT!2 App | 2 months | total days NEAT! app was used |
| Response to NEAT!2 Prompts | 2 months | percentage of notifications in which a transition from sitting to standing was detected |
| Physical Function Via Chair Stand Test | 5 months after surgery | Chair stand test - how many times a participant can stand up and sit down in 30 seconds |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristine Pellegrini, PhD
University of South Carolina
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percentage of time spent in Sedentary Behavior | 73.26 percentage of time in sedentary behavior STANDARD_DEVIATION 7.47 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 31 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 16 / 42 | 4 / 41 |
| serious Total, serious adverse events | 1 / 42 | 2 / 41 |
Outcome results
None listed