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Patients undergoing knee replacement typically report improved health-related quality of life, increased physical function, and reduced pain. Despite these improvements, physical activity levels remain unchanged, or only minimally increase from pre-operative levels, yet do not reach the same level of activity observed among healthy populations. Knee replacement patients often expect their activity levels and function to improve following surgery, but the majority of patients' activity levels 5 years post-operatively did not meet their pre-operative expectations. Even though improvements are observed in pain and function, reasons for the maintenance of low levels of activity are unknown. Technology has the potential to increase physical activity levels in these patients, particularly as 81% of knee replacement patients in our recent study had a smartphone, and 40% were willing to wear a wrist-worn physical activity monitor. As the average age of knee replacement continues to decrease, we anticipate that the percent of patients with a smartphone and willingness to wear an activity monitor will increase. In addition to technology, social support is associated with greater outcomes following knee replacement. Thus, wearing a wrist-worn physical activity monitor and providing additional opportunities for social support via the technology may increase physical activity levels in these patients. The current pilot study aims to gain preliminary data on the influence of wearables and social support on physical activity in knee replacement patients following surgery. Specifically, we aim to recruit 20 patients who will be randomized to one of two conditions: Fitbit vs. Fitbit+Support. Participants in the Fitbit group will receive a Fitbit and be encouraged to wear it for 4 months. Participants in the Fitbit+Support group will be asked to identify a "buddy." Both the participant and "buddy" will be given a Fitbit and they will be asked to friend each other via Fitbit and wear the monitor for 4 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitbit | Experimental | Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months. |
|
| Fitbit+Support | Experimental | Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitbit | Behavioral | Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Moderate/Vigorous Intensity Physical Activity | Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Social Support | Social Support & Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support | 4 months |
| Percentage of Participants Satisfied With the Fitbit |
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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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fitbit | Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months. Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months |
| FG001 | Fitbit+Support | Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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"Buddy participants" (n=7) were excluded from baseline analyses. Only knee replacement participants were included (n=8).
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| ID | Title | Description |
|---|---|---|
| BG000 | Fitbit | Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months. Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months |
| BG001 | Fitbit&Support |
| 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 | Moderate/Vigorous Intensity Physical Activity | Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit | "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses | Posted | Mean | Standard Deviation | minutes/day | 4 months |
|
4 months
This study was classified as minimal risk to 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 | Fitbit | Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months. Fitbit: Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Pellegrini | University of South Carolina | 803-777-0911 | cpellegrini@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 | Feb 21, 2018 | Sep 13, 2019 | Prot_SAP_000.pdf |
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| Fitbit+Support | Behavioral | Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. |
|
Acceptability of the Fitbit (% satisfied with Fitbit)
| 4 months |
| Fitbit Engagement | Percentage of days Fitbit was worn | 4 months |
Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months.
|
|
| Secondary | Social Support | Social Support & Exercise Survey - Family score (sum items 11 - 16 and 20 - 23); Scores can range between 10-50, with a higher score indicating more support | "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses | Posted | Mean | Standard Deviation | score on a scale | 4 months |
|
|
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| Secondary | Percentage of Participants Satisfied With the Fitbit | Acceptability of the Fitbit (% satisfied with Fitbit) | "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses | Posted | Count of Participants | Participants | 4 months |
|
|
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| Secondary | Fitbit Engagement | Percentage of days Fitbit was worn | "Buddy participants" (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses | Posted | Mean | Standard Deviation | Percentage of days | 4 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Fitbit+Support | Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. Fitbit+Support: Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to "Friend" each other on Fitbit and encouraged to wear the monitor over the next 4 months. | 0 | 15 | 0 | 15 | 0 | 15 |
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