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| Name | Class |
|---|---|
| Northwestern University | OTHER |
| Prisma Health-Midlands | OTHER |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEAT!2 | Experimental | 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. |
|
| MyKneeGuide | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEAT!2 | Behavioral | 8 week sedentary reduction program |
| |
| MyKneeGuide |
| 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 |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Pellegrini, PhD | University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42190239 | Derived | Pellegrini CA, Kennerley CL, Wilcox S, Lee J, DeVivo K, Horn K, Jamieson S, Hopkins J, Davis HT, Jackson Iii JB. Reducing Sedentary Time After Knee Replacement Using a Multicomponent mHealth Intervention: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 May 26;14:e83148. doi: 10.2196/83148. |
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De-identified study data will be made available 12 months after the primary manuscript is published.
12 months after primary manuscripts are published
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. NEAT!2: 8 week sedentary reduction program |
| FG001 | 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. MyKneeGuide: 8 week surgery recovery education program |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. NEAT!2: 8 week sedentary reduction program |
| BG001 | MyKneeGuide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objectively Measured (Actigraph) Sedentary Behavior at 2 Months | sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 3 months | Posted | Mean | Standard Deviation | minutes/day | 2 months |
|
5 months
adverse events among randomized participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. NEAT!2: 8 week sedentary reduction program |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gall bladder surgery | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Pellegrini | University of South Carolina | 803-777-0911 | pellegca@mailbox.sc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2023 | Feb 13, 2026 | Prot_SAP_000.pdf |
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| Behavioral |
8 week surgery recovery education program |
|
| 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 |
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 |
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.
MyKneeGuide: 8 week surgery recovery education program
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Percentage of time spent in Sedentary Behavior | Sedentary time assessed with waist worn Actigraph accelerometer | Mean | Standard Deviation | percentage of time in sedentary behavior |
|
|
|
| Primary | Objectively Measured (Actigraph) Sedentary Behavior at 5 Months | sedentary behavior (<100 counts/minute) measured with Actigraph accelerometers between baseline and 6 months | Posted | Mean | Standard Deviation | minutes/day | 5 months |
|
|
|
| Secondary | Physical Function | Six minute walk test - the number of feet an individual can walk in 6 minutes. | Posted | Mean | Standard Deviation | feet | 5 months after surgery |
|
|
|
| Secondary | WOMAC Pain Subscale | WOMAC Pain Subscale - Scores range from 0 (no pain) to 20 (maximal pain) | Posted | Mean | Standard Deviation | score on a scale | 5 months after surgery |
|
|
|
| Secondary | Total Physical Activity Measured by Actigraph Accelerometers | objectively measured light, moderate and vigorous activity (>= 100 counts/min) by Actigraph accelerometers | Posted | Mean | Standard Deviation | minutes/week | 5 months after surgery |
|
|
|
| Secondary | Adherence to Calls | Number of calls completed | Posted | Mean | Standard Deviation | calls completed | 2 months |
|
|
|
| Secondary | Adherence to NEAT!2 App | total days NEAT! app was used | Participants in NEAT!2 were included in analyses of the adherence to the NEAT!2 app. The MyKneeGuide participants did not receive the app, thus, the total days of adherence could not be calculated. | Posted | Mean | Standard Deviation | days | 2 months |
|
|
|
| Secondary | Response to NEAT!2 Prompts | percentage of notifications in which a transition from sitting to standing was detected | Participants in NEAT!2 were included in analyses of the response to NEAT!2 prompts. The MyKneeGuide participants did not receive the app, thus, response of NEAT!2 prompts could not be calculated. | Posted | Mean | Standard Deviation | percentage of notifications w/response | 2 months |
|
|
|
| Secondary | Physical Function Via Chair Stand Test | Chair stand test - how many times a participant can stand up and sit down in 30 seconds | Posted | Mean | Standard Deviation | repetitions | 5 months after surgery |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | seconds | 5 months after surgery |
|
|
|
| Other Pre-specified | Knee Symptoms - KOOS Pain | Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subcale (0 indicates extreme problems, 100 no problems) | Posted | Mean | Standard Deviation | score on a scale | 5 months |
|
|
|
| Other Pre-specified | Knee Symptoms - KOOS Symptoms | Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms subcale (0 indicates extreme problems, 100 no problems) | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Other Pre-specified | Knee Symptoms - KOOS ADL | Knee Injury and Osteoarthritis Outcome Score (KOOS) activities of daily living (ADL) subscale (0 indicates extreme problems, 100 no problems) | Posted | Mean | Standard Deviation | score on a scale | 5 months |
|
|
|
| Other Pre-specified | Knee Symptoms - KOOS Sport/Rec | Knee Injury and Osteoarthritis Outcome Score (KOOS) sport/recreation subcale (0 indicates extreme problems, 100 no problems) | Posted | Mean | Standard Deviation | score on a scale | 5 months |
|
|
|
| Other Pre-specified | Knee Symptoms - KOOS QoL | Knee Injury and Osteoarthritis Outcome Score (KOOS) Quality of Life (QoL) subcale (0 indicates extreme problems, 100 no problems) | Posted | Mean | Standard Deviation | score on a scale | 5 months |
|
|
|
| Other Pre-specified | Sedentary Time Via activPAL Accelerometers | minutes/day in sedentary time as assessed by activPAL accelerometer worn for 7 days on the thigh | Posted | Mean | Standard Deviation | minutes/day | 5 months |
|
|
|
| Other Pre-specified | 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) | Posted | Mean | Standard Deviation | T-score | 5 months |
|
|
|
| Other Pre-specified | 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) | Posted | Mean | Standard Deviation | T Score | 5 months |
|
|
|
| Other Pre-specified | 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) | Posted | Mean | Standard Deviation | T-Score | 5 months |
|
|
|
| Other Pre-specified | Sedentary Time Via SIT-Q | Self-reported sitting time on weekday in hours/day as assessed by the SIT-Q survey | Posted | Mean | Standard Deviation | hours/day | 5 months |
|
|
|
| 0 |
| 42 |
| 1 |
| 42 |
| 16 |
| 42 |
| EG001 | 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. MyKneeGuide: 8 week surgery recovery education program | 0 | 41 | 2 | 41 | 4 | 41 |
| Coronary blockage | Cardiac disorders | Systematic Assessment |
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| knee injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| spinal stenosis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| shoulder injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| hip injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| venous insufficiency | Vascular disorders | Systematic Assessment |
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| High blood pressure | Cardiac disorders | Systematic Assessment |
|
| mass removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| back injury/pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
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