Arthroplasty, Replacement, Knee
Conditions
Brief summary
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.
Interventions
BEHAVIORALFitbit
Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
BEHAVIORALFitbit+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.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Knee replacement patients must (1) have had a knee replacement in the last 12 months; (2) have a computer or smartphone compatible with Fitbit, (3) be English speaking, (4) willing to wear the Fitbit for 4 months, and (5) have a buddy willing to participate. * Patient buddies must: (1) have a computer or smartphone compatible with Fitbit, (2) be English speaking, and (3) willing to wear the Fitbit for 4 months.
Exclusion criteria
* Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Moderate/Vigorous Intensity Physical Activity | 4 months | Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Social Support | 4 months | 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 |
| Percentage of Participants Satisfied With the Fitbit | 4 months | Acceptability of the Fitbit (% satisfied with Fitbit) |
| Fitbit Engagement | 4 months | Percentage of days Fitbit was worn |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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. | 8 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Fitbit | Fitbit&Support | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 4 Participants | 10 Participants |
| Age, Continuous | 58.6 years STANDARD_DEVIATION 7.6 | 62.5 years STANDARD_DEVIATION 8.5 | 60.6 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 8 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 15 |
| other Total, other adverse events | 0 / 8 | 0 / 15 |
| serious Total, serious adverse events | 0 / 8 | 0 / 15 |
Outcome results
Primary
Moderate/Vigorous Intensity Physical Activity
Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit
Time frame: 4 months
Population: Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit | Moderate/Vigorous Intensity Physical Activity | 26.9 minutes/day | Standard Deviation 28.4 |
| Fitbit+Support | Moderate/Vigorous Intensity Physical Activity | 33.1 minutes/day | Standard Deviation 32.7 |
Secondary
Fitbit Engagement
Percentage of days Fitbit was worn
Time frame: 4 months
Population: Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit | Fitbit Engagement | 88.9 Percentage of days | Standard Deviation 13.2 |
| Fitbit+Support | Fitbit Engagement | 99.3 Percentage of days | Standard Deviation 1.3 |
Secondary
Percentage of Participants Satisfied With the Fitbit
Acceptability of the Fitbit (% satisfied with Fitbit)
Time frame: 4 months
Population: Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fitbit | Percentage of Participants Satisfied With the Fitbit | 7 Participants |
| Fitbit+Support | Percentage of Participants Satisfied With the Fitbit | 6 Participants |
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
Time frame: 4 months
Population: Buddy participants (n=7) were excluded from Fitbit+Support main analyses. Only knee replacement participants who completed the study were included in analyses
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fitbit | Social Support | 16.6 score on a scale | Standard Deviation 7.9 |
| Fitbit+Support | Social Support | 25.0 score on a scale | Standard Deviation 12.2 |