N/A
N=17
Active Seating System to Lessen Sedentariness in Older Adults: In-home Testing Phase
Healthy Lifestyle
Bottom Line
View on ClinicalTrials.gov: NCT05510297 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present — -1.7100 hours/24-hr period — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FitSitt Prototype (Device)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Southern California
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present |
-1.7100 | 0.007 sig |
| SECONDARY Daily Steps Change From Baseline to up to 7 Days With Intervention Present |
3142.88 | 0.074 |
| SECONDARY Self-reported Physical Activity Change From Baseline to 3-7 Days |
4.44 | 0.685 |
| SECONDARY Self-reported Fatigue Severity Change From Baseline to 3-7 Days |
-0.51 | 0.191 |
| SECONDARY Self-reported Pain Severity Change From Baseline to 3-7 Days |
-0.45 | 0.218 |
| SECONDARY Self-reported Pain Interference Change From Baseline to 3-7 Days |
-0.92 | 0.125 |
| SECONDARY Self-reported Joint Stiffness Change From Baseline to 3-7 Days |
0.0013 | 0.960 |
| SECONDARY FitSitt Seat Occupancy Usage Behavior |
214.20 | — |
| SECONDARY FitSitt Pedaling Usage Behavior |
101.3 | — |
| SECONDARY FitSitt Use Self-efficacy |
7.66 | — |
| SECONDARY Fatigue Interference Change |
-0.51 | 0.168 |
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
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05510297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.