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临床试验/NCT03921840
NCT03921840已完成不适用

A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Change in Objective Sleep Duration

研究概览

简要总结

It is well recognized that physical activity/exercise is an effective intervention to improve sleep, reduce pain and improve function in a variety of pain conditions. Traditional interventions to increase physical activity are challenging in older adults due to extensive staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a cohort of older adults (without dementia) with both chronic musculoskeletal pain and nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 27 cognitively intact elders were enrolled and randomly allocated to intervention or control group. Participants in the intervention arm received a 2-hour in person education session, and personalized, circadian-based activity guidelines, with real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal. The control group received general education on physical activity in older adults and continue routine daily activity for 12 weeks.

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

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Intact cognition
  • Poor sleep quality
  • Self-reported presence of pain
  • Capacity for mild to moderate physical activity.

排除标准

  • Non-ambulatory or have severely impaired mobility,
  • Visual or hearing impairment that interfered with assessments, and
  • An acute or a terminal illness
  • Neuropathic pain

结局指标

主要结局

Change in Objective Sleep Duration

时间窗: Week 1, Week 14

Total sleep time (minutes) will be measured using actigraph

Change in Sleep Efficiency as Assessed by Actigraphy

时间窗: Week 1, Week 14

Sleep efficiency (reported as a percentage)will be measured using actigraph

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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