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NCT03037619

Fitbit and Social Support in Knee Replacement Patients & Buddies

Completed NA Results posted Last updated 16 September 2019
What this trial tests

NA trial testing Fitbit in Arthroplasty, Replacement, Knee in 23 participants. Completed in 10 November 2018.

Timeline
6 March 2017
Primary endpoint
10 November 2018
10 November 2018

Quick facts

Lead sponsorUniversity of South Carolina
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment23
Start date6 March 2017
Primary completion10 November 2018
Estimated completion10 November 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of South Carolina

Who can join

Eligibility, any sex, with Arthroplasty, Replacement, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Moderate/Vigorous Intensity Physical Activity Primary · 4 months

Number of minutes/day of moderate and vigorous intensity physical activity measured by the Fitbit

GroupValue95% CI
Fitbit26.9± 28.4
Fitbit+Support33.1± 32.7
Social Support Secondary · 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

GroupValue95% CI
Fitbit16.6± 7.9
Fitbit+Support25.0± 12.2
Percentage of Participants Satisfied With the Fitbit Secondary · 4 months

Acceptability of the Fitbit (% satisfied with Fitbit)

GroupValue95% CI
Fitbit7
Fitbit+Support6
Fitbit Engagement Secondary · 4 months

Percentage of days Fitbit was worn

GroupValue95% CI
Fitbit88.9± 13.2
Fitbit+Support99.3± 1.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Fitbit

Trials testing the same drug.

Other recruiting trials for Arthroplasty, Replacement, Knee

Currently open trials in the same condition.

Other University of South Carolina trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03037619.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing