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

NCT05510297 | Completed Results

• 2 other identifiers: UP-22-00037R43AG074697
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Lifestyle

Outcome Measures

Primary Outcomes (1)

• Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present

  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.

  Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline

Secondary Outcomes (10)

• 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

Study Arms (1)

In-home feasibility test

OTHER

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.

Device: FitSitt Prototype

Interventions

FitSitt Prototype DEVICE

FitSitt merges features of a posture chair, exercise machine, and tracking means. It provides seated stepping, postural support, and semi-recline capabilities. A digital interface and app will allow users to set goals and track performance.

In-home feasibility test

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Results Point of Contact

• Title: Dr. Stacey Schepens Niemiec
• Organization: University of Southern California

schepens@usc.edu

323-442-2069

Study Officials

• Stacey L Schepens Niemiec, PhD

  University of Southern California Chan Division of OS-OT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: September 27, 2023
• Primary Completion: March 18, 2024
• Study Completion: March 18, 2024
• Last Updated: April 24, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)