Development of a Comprehensive, Active Seating System to Lessen Sedentariness and Improve Health and Wellness in Older Adults: In-home Testing Phase
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present
研究概览
简要总结
FitSitt is an innovative device tailored to older adults that increases the convenience of breaking up sedentary activity and incorporating physical activity into in-home daily routines. This comprehensive seating solution merges features of a posture chair, exercise machine, rehabilitation tool, and activity tracker. Its primary purpose is to reduce daily immobile time, offering users a convenient means for replacing sedentary bouts with varying intensities of physical activity, ultimately leading to improved health. FitSitt aims to improve the baseline activity profile of its users by providing a comprehensive wellness solution including a non-disruptive in-home means for physical activity engagement while allowing users to continue participation in desired seated activities. In so doing, FitSitt has the potential to decrease health-harmful sedentary activity in a wide variety of high-risk individuals and occupational contexts. The initial development of FitSitt for this Phase I proposal, however, will target community-dwelling older adults.
Co-led by Activ Sitting, Inc. and USC, Phase I will include three study phases (i.e., focus group, in-lab testing, in-home testing) to determine user acceptability, feasibility of procedures, safety, and preliminary efficacy to affect health and behavior outcomes. Clinical trial activities occur within the in-home testing stage and will focus on user acceptability and preliminary efficacy to affect health and behavioral outcomes. This information will be used along with other information collected from the overall study to redesign and enhance the current FitSitt prototype and prepare the system to be tested in a fully powered Phase II study of the enhanced FitSitt's efficacy to improve health in community-living older people. As currently designed, FitSitt provides convenience, comfort, and health value-add for myriad older adults, ensuring scalability and sustainability of broad use across communities and markets. This project will facilitate the development of an optimized, in-home, comprehensive sedentary activity solution for older adults and countless other populations that could benefit from reducing the deleterious health effects of extended inactive behavior through convenient and comfortable-to-use intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years old or older
- •English-speaking
- •Live in local Los Angeles area and no plans to vacation away from home during the trial period
- •Self-reported ability to safely engage in 30 minutes of light-intensity activity per day
- •Self-reported ability to pedal comfortably without stopping for 5 minutes
- •Community-dwelling
排除标准
- •Dependence in transferring to a chair safely
- •Inability to safely and reliably access and operate FitSitt (ascertained by a brief demonstration at beginning of in-home visit)
- •A member living in the same household participated in the in-home testing stage of this study
- •Participated in the in-lab testing stage of the study already
- •Unstable health conditions such as uncontrolled blood pressure, end-stage renal failure on renal replacement therapy, or malignancy currently on chemotherapy.
研究组 & 干预措施
In-home feasibility test
In this single-arm trial, participants will use an active seating system for a 3- to 7-day period. The system provides a seating platform and treadles to pedal while in a seated or semi-reclined position. The system will also include a digital user interface to track performance.
干预措施: FitSitt Prototype (Device)
结局指标
主要结局
Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present
时间窗: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
Daily prolonged sedentary bouts (objective sedentary activity) will be measured in real time using the activPAL thigh-worn accelerometer during a 72-hour monitoring period before introduction of FitSitt (i.e., pre-intervention) and throughout a 3- to 7-day long monitoring period when FitSitt is present (i.e., intervention-present). "Prolonged" sedentary bouts is identified by an activPAL proprietary algorithm of sedentariness \>= 30 minutes in duration, and will be merged with data captured with FitSitt sensors when sitting in the FitSitt. Bouts will be expressed in hours per 24-hour period.
次要结局
- Daily Steps Change From Baseline to up to 7 Days With Intervention Present(Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline)
- Self-reported Physical Activity Change From Baseline to 3-7 Days(Baseline and 3-7 days)
- Self-reported Fatigue Severity Change From Baseline to 3-7 Days(Baseline and 3-7 days)
- Self-reported Pain Severity Change From Baseline to 3-7 Days(Baseline and 3-7 days)
- Self-reported Pain Interference Change From Baseline to 3-7 Days(Baseline and 3-7 days)
- Self-reported Joint Stiffness Change From Baseline to 3-7 Days(Baseline and 3-7 days)
- FitSitt Seat Occupancy Usage Behavior(From baseline through 3-7 days (daily))
- FitSitt Pedaling Usage Behavior(From baseline through 3-7 days (daily))
- FitSitt Use Self-efficacy(3-7 days (post-intervention))
- Fatigue Interference Change(Baseline and 3-7 days)
研究者
Stacey L. Schepens Niemiec
Associate Professor
University of Southern California