Active Seating System to Lessen Sedentariness in Older Adults: In-home Testing Phase

University of Southern California

Status: Completed

Conditions: Healthy Lifestyle

Treatments: Device: FitSitt Prototype

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05510297

UP-22-00037

R43AG074697 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

In-home feasibility test

Other group

Description:

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.

Treatment:

Device: FitSitt Prototype