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| ID | Type | Description | Link |
|---|---|---|---|
| R43AG074697 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stacey L Schepens Niemiec, PhD | University of Southern California Chan Division of OS-OT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States |
This proposal will produce proprietary data relevant to the patented FitSitt system owned by Activ Sitting, Inc. Under the Small Business Act, SBIR/STTR grantees are protected from disclosure and nongovernmental use of all SBIR/STTR data developed from work performed under a SBIR funding agreement for a period of 20 years after the closeout of a Phase I trial. Accordingly, the team will not engage in data sharing.
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29 screened for enrollment; 12 screen failures; 17 enrolled by signing consent and beginning at least one baseline survey activity; 15 began the intervention period (2 had withdrawn prior to the intervention beginning).
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| ID | Title | Description |
|---|---|---|
| FG000 | In-home Feasibility Test | 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. FitSitt Prototype: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | In-home Feasibility Test | 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. FitSitt Prototype: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | hours/24-hr period | Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline |
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In-home Feasibility Test | 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. FitSitt Prototype: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation activPAL | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant reported skin irritation and warmth from the activPAL activity monitor to the thigh. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stacey Schepens Niemiec | University of Southern California | 323-442-2069 | schepens@usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2023 | Mar 12, 2025 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2022 | Aug 19, 2022 | ICF_001.pdf |
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| 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 Severity 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 | The Musculoskeletal Stiffness Questionnaire (MSQ) is a 21-item patient-reported outcome measure that takes approximately ≤10 minutes to complete. It assesses joint stiffness and the physical and psychosocial impact of stiffness on daily life. Items are scored on a Likert scale, and the raw scores are transformed into a total percentage score ranging from 0 to 100, with higher scores indicating greater joint stiffness and worse outcomes. Validation studies have included healthy adults across the lifespan as well as persons with rheumatoid arthritis and chikungunya disease. The total score is derived by summing item responses, converting the total to a percentage of the maximum possible score. If subscale scores are reported, each subscale score also ranges from 0 to 100. Unit of Measure: Scores on a scale from 0-100 | Baseline and 3-7 days |
| FitSitt Seat Occupancy Usage Behavior | FitSitt seat occupancy usage behavior is defined as number of minutes spent sitting 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) |
| Fatigue Interference Change | 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Daily hours reported watching TV | Median | Inter-Quartile Range | Hours/day |
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| Confidence using a smartphone | Self-reported confidence in using a smartphone generally on a scale of 1=poor to 10=excellent. | Median | Inter-Quartile Range | units on a scale |
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| Smartphone operating system | Not all participants reported having a smartphone; smartphone ownership was not a requirement of the study. | Count of Participants | Participants |
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| Years of smartphone ownership | Not all participants owned a smartphone; this was not a requirement for the study. Only those who owned a smartphone were reported here. | Median | Inter-Quartile Range | years |
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| Health conditions | Only health conditions that were self-reported by 3 or more participants are listed here. | Number | participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | steps per day | Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-7 days |
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| Secondary | Self-reported Fatigue Severity 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-7 days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-7 days |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-7 days |
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| Secondary | Self-reported Joint Stiffness Change From Baseline to 3-7 Days | The Musculoskeletal Stiffness Questionnaire (MSQ) is a 21-item patient-reported outcome measure that takes approximately ≤10 minutes to complete. It assesses joint stiffness and the physical and psychosocial impact of stiffness on daily life. Items are scored on a Likert scale, and the raw scores are transformed into a total percentage score ranging from 0 to 100, with higher scores indicating greater joint stiffness and worse outcomes. Validation studies have included healthy adults across the lifespan as well as persons with rheumatoid arthritis and chikungunya disease. The total score is derived by summing item responses, converting the total to a percentage of the maximum possible score. If subscale scores are reported, each subscale score also ranges from 0 to 100. Unit of Measure: Scores on a scale from 0-100 | Posted | Mean | Standard Deviation | percent | Baseline and 3-7 days |
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| Secondary | FitSitt Seat Occupancy Usage Behavior | FitSitt seat occupancy usage behavior is defined as number of minutes spent sitting 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. | Posted | Mean | Standard Deviation | minutes per day | From baseline through 3-7 days (daily) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | minutes per day | From baseline through 3-7 days (daily) |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3-7 days (post-intervention) |
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| Secondary | Fatigue Interference Change | 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). | Posted | Mean | Standard Deviation | score on a scale | Baseline and 3-7 days |
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| 0 |
| 17 |
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| 17 |
| 1 |
| 17 |
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