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The purpose is to examine the effects of an online physical activity program on moderate to vigorous intensity physical activity, pain, and physical function in adults with knee replacement at 3 months (post-intervention) and 6 months (maintenance).
Participants with knee replacement will be randomized to start the online physical activity program (Energize!) either immediately or after 3 months. The online program consists of weekly physical activity goals, video lessons, action planning, and homework to help increase physical activity to 200 min/week. Assessments will be completed at baseline, 3 months, and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energize! | Experimental | Participants randomized to Energize! will start the program immediately after baseline. |
|
| Delayed Energize! | Other | Participants randomized to Delayed Energize! will start the program after the 3 month assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energize! | Behavioral | Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minutes of Moderate to Vigorous Intensity Physical Activity | Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers | baseline to 3 months |
| Pain Intensity | Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain | baseline to 3 months |
| Self-reported Physical Function | Physical function assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function. A t-score of 50 indicates the population mean with a standard deviation of 10. | baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes/Week of Moderate to Vigorous Intensity Physical Activity | Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers worn on the waist for 7 days | 3 months to 6 months |
| Pain Intensity |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Energize Program - Video Lessons Viewed | Number of video lessons viewed | 3 months |
| Adherence to Energize Program - Planning or Reporting Exercise Minutes | Number of weeks exercise minutes were planned or reported |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Carolina | Columbia | South Carolina | 29208 | United States |
As this is a pilot study, we do not have a plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Energize! | Participants randomized to Energize! will start the program immediately after baseline. Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. |
| FG001 | Delayed Energize! | Participants randomized to Delayed Energize! will start the program after the 3 month assessment. Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Energize! | Participants randomized to Energize! will start the program immediately after baseline. Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. |
| BG001 | Delayed Energize! |
| 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 | Minutes of Moderate to Vigorous Intensity Physical Activity | Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers | Posted | Mean | Standard Deviation | minutes/week | baseline to 3 months |
|
6 months
adverse events
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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 | Energize! | Participants randomized to Energize! will start the program immediately after baseline. Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to Hypokalemia | Metabolism and nutrition 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 | Sep 4, 2023 | Sep 19, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain
| 3 months to 6 months |
| Self-reported Physical Function | Physical function assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function. A t-score of 50 indicates the population mean with a standard deviation of 10. | 3 months to 6 months |
| 3 months |
| Adherence to Energize Program - Homework Assignments | Number of homework assignments completed | 3 months |
Participants randomized to Delayed Energize! will start the program after the 3 month assessment. Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. |
| 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 |
|
| Actigraph assessed moderate-vigorous intensity physical activity | Mean | Standard Deviation | minutes/week |
|
|
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| Primary | Pain Intensity | Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain | Posted | Mean | Standard Error | score on a scale | baseline to 3 months |
|
|
|
| Primary | Self-reported Physical Function | Physical function assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function. A t-score of 50 indicates the population mean with a standard deviation of 10. | Posted | Mean | Standard Deviation | t score | baseline to 3 months |
|
|
|
| Secondary | Minutes/Week of Moderate to Vigorous Intensity Physical Activity | Minutes of moderate to vigorous intensity physical activity assessed by Actigraph accelerometers worn on the waist for 7 days | Posted | Mean | Standard Deviation | minutes/week | 3 months to 6 months |
|
|
|
| Secondary | Pain Intensity | Pain intensity assessed by Patient-Reported Outcomes Measurement Information System pain intensity survey. 0 represents no pain and 10 reports the most severe pain | Posted | Mean | Standard Deviation | score on a scale | 3 months to 6 months |
|
|
|
| Secondary | Self-reported Physical Function | Physical function assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) physical function/mobility survey. A t-score of 0 represents poor function compared to average and 100 represents better function. A t-score of 50 indicates the population mean with a standard deviation of 10. | Posted | Mean | Standard Deviation | T score | 3 months to 6 months |
|
|
|
| Other Pre-specified | Adherence to Energize Program - Video Lessons Viewed | Number of video lessons viewed | Posted | Mean | Standard Deviation | Videos watched | 3 months |
|
|
|
| Other Pre-specified | Adherence to Energize Program - Planning or Reporting Exercise Minutes | Number of weeks exercise minutes were planned or reported | Posted | Mean | Standard Deviation | Number of weeks planned | 3 months |
|
|
|
| Other Pre-specified | Adherence to Energize Program - Homework Assignments | Number of homework assignments completed | Posted | Mean | Standard Deviation | Number of homework assignments done | 3 months |
|
|
|
| 0 |
| 27 |
| 2 |
| 27 |
| 8 |
| 27 |
| EG001 | Delayed Energize! | Participants randomized to Delayed Energize! will start the program after the 3 month assessment. Energize!: Energize! is 3 month online physical activity program which consists of weekly physical activity goals, video lessons, action planning, and homework. | 0 | 23 | 0 | 23 | 6 | 23 |
| Septic arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hiatal hernia | Gastrointestinal disorders | Systematic Assessment |
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| Neck injury or strain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shoulder injury/pain/surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Cervical spinal fusion | Nervous system disorders | Systematic Assessment |
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| Hip injury/surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Atrial fibrilation | Cardiac disorders | Systematic Assessment |
|
| Low oxygen levels | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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