Clinical trial NCT05510297: Active Seating System to Lessen Sedentariness in Older Adults: In-home Testing Phase
Official title: Development of a Comprehensive, Active Seating System to Lessen Sedentariness and Improve Health and Wellness in Older Adults: In-home Testing Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Lifestyle
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-08-22
Enrollment: 17
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Age 65 years old or older
2. English-speaking
3. Live in local Los Angeles area and no plans to vacation away from home during the trial period
4. Self-reported ability to safely engage in 30 minutes of light-intensity activity per day
5. Self-reported ability to pedal comfortably without stopping for 5 minutes
6. Community-dwelling

Exclusion Criteria:

1. Dependence in transferring to a chair safely
2. Inability to safely and reliably access and operate FitSitt (ascertained by a brief demonstration at beginning of in-home visit)
3. A member living in the same household participated in the in-home testing stage of this study
4. Participated in the in-lab testing stage of the study already
5. Unstable health conditions such as uncontrolled blood pressure, end-stage renal failure on renal replacement therapy, or malignancy currently on chemotherapy.

Primary outcomes:
measure: Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present
timeFrame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
Secondary outcomes:
measure: Daily Steps Change From Baseline to up to 7 Days With Intervention Present
timeFrame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
measure: Self-reported Physical Activity Change From Baseline to 3-7 Days
timeFrame: Baseline and 3-7 days
measure: Self-reported Fatigue Severity Change From Baseline to 3-7 Days
timeFrame: Baseline and 3-7 days
measure: Self-reported Pain Severity Change From Baseline to 3-7 Days
timeFrame: Baseline and 3-7 days
measure: Self-reported Pain Interference Change From Baseline to 3-7 Days
timeFrame: Baseline and 3-7 days
measure: Self-reported Joint Stiffness Change From Baseline to 3-7 Days
timeFrame: Baseline and 3-7 days
measure: FitSitt Seat Occupancy Usage Behavior
timeFrame: From baseline through 3-7 days (daily)
measure: FitSitt Pedaling Usage Behavior
timeFrame: From baseline through 3-7 days (daily)
measure: FitSitt Use Self-efficacy
timeFrame: 3-7 days (post-intervention)
measure: Fatigue Interference Change
timeFrame: Baseline and 3-7 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California Chan Division of OS-OT
name: Stacey L Schepens Niemiec, PhD
role: PRINCIPAL_INVESTIGATOR
References: