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

Study Overview
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Brief Summary
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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.

Official Title
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Development of a Comprehensive, Active Seating System to Lessen Sedentariness and Improve Health and Wellness in Older Adults: In-home Testing Phase

Conditions
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Healthy Lifestyle

Intervention / Treatment
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* Device: FitSitt Prototype


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: In-home feasibility test<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily Steps change from baseline to up to 7 days with intervention present | Daily Steps (objective physical activity) will be measured in real time using the activPAL thigh-worn accelerometer during a 72-hour monitoring period pre-intervention and throughout a 3- to 7-day long monitoring period when the intervention is present. Steps (i.e., pedaling counts) accumulated while sitting and using FitSitt will be merged with the activPAL data. Daily steps are expressed in counts per 24-hour period. | Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline | 
| Self-reported Physical Activity change from baseline to 3-7 days | Self-reported physical activity will be measured via the Physical Activity Scale for the Elderly (PASE). PASE is a ten-item instrument designed to assess engagement in physical activities commonly pursued by older adults, including those related to leisure, household, and occupational tasks. The tool is a valid and reliable measure of physical activity engagement in the older adult population. Scores range from 0 to 361. Higher scores indicate a higher level of activity. | Baseline and 3-7 days | 
| Self-reported Fatigue change from baseline to 3-7 days | Fatigue will be measured using the Brief Fatigue Inventory, a 9-item questionnaire that captures subjective report of fatigue severity. It takes approximately 5 minutes to complete. This tool demonstrates good psychometric properties and is sensitive to change. Higher scores indicate greater fatigue. Scores range from 0 to 10 (mean of 9 items on a 0-10 scale). | Baseline and 3-7 days | 
| Self-reported Pain Severity change from baseline to 3-7 days | Pain severity will be assessed using two Brief Pain Inventory (BPI) - Short Form subscales: severity. The severity subscale measures amount of pain presently and at its worst, least, and average severity. This subscale is considered valid and reliable. Higher scores = greater pain severity. Scores range from 0 to 10 and are calculated using the mean of the items. | Baseline and 3-7 days | 
| Self-reported Pain Interference change from baseline to 3-7 days | Pain interference will be assessed using the Brief Pain Inventory (BPI) - Short Form subscale: pain interference. The interference subscale assesses how much a person's pain disrupts everyday life. This subscale is considered valid and reliable. Higher scores indicate greater pain interference. Scores range from 0 to 10 and are calculated using the mean of the items. | Baseline and 3-7 days | 
| Self-reported Joint Stiffness change from baseline to 3-7 days | Musculoskeletal Stiffness Questionnaire (MSQ) is a 21-item form that takes ≤10 minutes to complete. This patient reported outcome measure has been used to assess overall joint stiffness as well as the physical and psychosocial impact of stiffness on everyday life in healthy adults across the lifespan. Studies include validation of the tool for persons with rheumatoid arthritis and chikungunya disease. Scores are expressed as a percent, with higher percent scores indicating greater joint stiffness. | Baseline and 3-7 days | 
| FitSitt Seat Occupancy Usage Behavior | FitSitt seat occupancy usage behavior is defined as number of minutes spent witting in FitSitt across a 24-hour day, as captured by onboard FitSitt sensors. Users will have FitSitt available to them for 3 to 7 days. | From baseline through 3-7 days (daily) | 
| FitSitt Pedaling Usage Behavior | FitSitt pedaling usage behavior is defined as number of minutes spent pedaling while seated in FitSitt across a 24-hour day, as captured by onboard FitSitt sensors. Users will have FitSitt available to them for 3 to 7 days. | From baseline through 3-7 days (daily) | 
| FitSitt Use Self-efficacy | FitSitt use self-efficacy will be assessed using a study-specific adaptation of the Self-Efficacy for Exercise scale, which we have entitled FitSitt Use Self-efficacy. Items have been modified to focus on using FitSitt as the mode of sedentary activity disruption rather than addressing exercise in general terms. The form is expected to take approximately 3 minutes to complete. Higher scores would indicate greater self-efficacy to use the device. Scores range from 0 to 10 and are calculated using the mean of the items. | 3-7 days (post-intervention) |