Fitbit and Social Support in Knee Replacement Patients & Buddies

Not Applicable

Completed

• Conditions: Arthroplasty, Replacement, Knee
• Interventions: Behavioral: Fitbit; Behavioral: Fitbit+Support

• Registration Number: NCT03037619
• Lead Sponsor: University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-01-31
• Study Start: 2017-03-06
• Primary Completion: 2018-11-10
• Study Completion: 2018-11-10
• Results First Submitted: 2019-07-25
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-13
• Last Update Submitted: 2019-09-13
• Results First Posted: 2019-09-16
• Last Update Posted: 2019-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fitbit	Fitbit	Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.
Fitbit+Support	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.

Primary Outcome Measures

Name	Time	Method
Moderate/Vigorous Intensity Physical Activity	4 months	Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit

Secondary Outcome Measures

Name	Time	Method
Fitbit Engagement	4 months	Percentage of days Fitbit was worn
Percentage of Participants Satisfied With the Fitbit	4 months	Acceptability of the Fitbit (% satisfied with Fitbit)
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

Trial Locations

Locations (1)

University of South Carolina; 🇺🇸 Columbia, South Carolina, United States