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临床试验/NCT03037619
NCT03037619已完成不适用

Influence of Wearable Activity Monitors and Social Support on Physical Activity After Knee Replacement

University of South Carolina2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2017年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
2
主要终点
Moderate/Vigorous Intensity Physical Activity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Knee replacement patients will be excluded if they have another knee replacement scheduled within the next 4 months.

研究组 & 干预措施

Fitbit

Experimental

Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months.

干预措施: Fitbit (Behavioral)

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.

干预措施: Fitbit+Support (Behavioral)

结局指标

主要结局

Moderate/Vigorous Intensity Physical Activity

时间窗: 4 months

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

次要结局

  • Fitbit Engagement(4 months)
  • Percentage of Participants Satisfied With the Fitbit(4 months)
  • Social Support(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christine A Pellegrini, PhD

Research Assistant Professor

University of South Carolina

研究点 (2)

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