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| Name | Class |
|---|---|
| Prisma Health-Midlands | OTHER |
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The purpose of this study is to examine the feasibility and preliminary efficacy of a physical therapist led physical activity intervention for knee replacement patients within an outpatient physical therapy facility.
Physical activity does not typically increase after knee replacement; thus, the purpose of this study is to examine if physical activity levels will be higher among knee replacement patients who receive a physical therapist led physical activity intervention during standard physical therapy sessions. Physical activity levels will be assessed at the start of outpatient therapy and at 12 weeks after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PATH | Experimental | PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions. |
|
| PATH-12 | Active Comparator | PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Physical Therapy | Behavioral | Participants will receive standard outpatient physical therapy that is typical following knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled | Feasibility will be determined based on the number of participants enrolled vs. the number approached | Baseline |
| Percentage of Participants Who Complete the 12 Week Assessment | Acceptability will be determined by the percentage of participants completing the 12 week assessment. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Moderate-Vigorous Intensity Physical Activity | Total number of minutes of objectively-measured moderate-vigorous intensity (>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days. | 12 weeks |
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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 |
|---|---|---|---|---|---|---|
| Palmetto Health- USC Orthopedic Center | Columbia | South Carolina | 29203 | United States | ||
| University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36106651 | Derived | Pellegrini CA, Brown D, DeVivo KE, Lee J, Wilcox S. Promoting physical activity via physical therapist following knee replacement: A pilot randomized controlled trial. PM R. 2023 Aug;15(8):965-975. doi: 10.1002/pmrj.12895. Epub 2022 Dec 15. |
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Given the preliminary nature of the study and small sample size, we do not plan to share data with others, unless requested to do so.
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| ID | Title | Description |
|---|---|---|
| FG000 | PATH | PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement. |
| FG001 | PATH-12 | PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PATH | PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants Enrolled | Feasibility will be determined based on the number of participants enrolled vs. the number approached | The overall number of participants analyzed reflects the total number of participants that were approached and screened for participation | Posted | Count of Participants | Participants | Baseline |
|
|
3 months
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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 | PATH | PATH participants will receive Standard Outpatient Physical Therapy. In addition, physical therapist discuss physical activity & assist with goal setting during therapy sessions. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical therapist discuss aerobic physical activity: Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement. |
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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 | Mar 17, 2020 | Jun 28, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Physical therapist discuss aerobic physical activity | Behavioral | Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement. |
|
| Physical activity session | Behavioral | Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement. |
|
| Columbia |
| South Carolina |
| 29208 |
| United States |
| BG001 | PATH-12 | PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Moderate-vigorous intensity physical activity | Participants were only included if they had 4 valid days of at least 10 hours of wear time | Mean | Standard Deviation | minutes/week |
|
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| Primary | Percentage of Participants Who Complete the 12 Week Assessment | Acceptability will be determined by the percentage of participants completing the 12 week assessment. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Moderate-Vigorous Intensity Physical Activity | Total number of minutes of objectively-measured moderate-vigorous intensity (>2020 counts/min) physical activity/week assessed using Actigraph link activity monitors worn around the waist for 7 days. | Only participants with 4 valid days of activity monitor wear (at least 10 hours of wear time) were included in analyses | Posted | Mean | Standard Deviation | minutes/week | 12 weeks |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | PATH-12 | PATH-12 participants will receive Standard Outpatient Physical Therapy. In addition, PATH-12 participants will receive a Physical activity session (1-hour) focusing on physical activity and goal setting at 12 weeks after surgery. Standard Physical Therapy: Participants will receive standard outpatient physical therapy that is typical following knee replacement Physical activity session: Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement. | 0 | 21 | 0 | 21 | 0 | 21 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|