Healthy LifestyleNCT05510297
Active Seating System to Lessen Sedentariness in Older Adults: In-home Testing Phase
A study testing FitSitt Prototype in people with Healthy Lifestyle, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Lifestyle
- What is being tested?
- FitSitt Prototype
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Development of a Comprehensive, Active Seating System to Lessen Sedentariness and Improve Health and Wellness in Older Adults: In-home Testing Phase
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
- Being tested
- FitSitt Prototype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FitSitt PrototypeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: FitSitt Prototype |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline and 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start27 Sep 2023
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy LifestyleStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stacey L. Schepens Niemiec, University of Southern California
- Investigators
- Stacey L Schepens Niemiec, PhD, Principal investigator, University of Southern California Chan Division of OS-OT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510297
- Sponsor's protocol ID
- UP-22-00037
- Other IDs
- R43AG074697
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2022
- Last updated
- 24 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Comprehensive, Active Seating System to Lessen Sedentariness and Improve Health and Wellness in Older Adults: In-home Testing Phase
- ClinicalTrials.gov ID
- NCT05510297
- Acronym / sponsor ID
- UP-22-00037
- Conditions
- Healthy Lifestyle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Posted 24 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-home feasibility test | Other | Device: FitSitt PrototypeIn 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FitSitt PrototypeFitSitt 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. | Device | In-home feasibility test |
Primary outcome
Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present
Time frame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
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.
10 secondary outcomes
Daily Steps Change From Baseline to up to 7 Days With Intervention Present
Time frame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
Self-reported Physical Activity Change From Baseline to 3-7 Days
Time frame: Baseline and 3-7 days
Self-reported Fatigue Severity Change From Baseline to 3-7 Days
Time frame: Baseline and 3-7 days
Self-reported Pain Severity Change From Baseline to 3-7 Days
Time frame: Baseline and 3-7 days
Self-reported Pain Interference Change From Baseline to 3-7 Days
Time frame: Baseline and 3-7 days
Self-reported Joint Stiffness Change From Baseline to 3-7 Days
Time frame: Baseline and 3-7 days
FitSitt Seat Occupancy Usage Behavior
Time frame: From baseline through 3-7 days (daily)
FitSitt Pedaling Usage Behavior
Time frame: From baseline through 3-7 days (daily)
FitSitt Use Self-efficacy
Time frame: 3-7 days (post-intervention)
Fatigue Interference Change
Time frame: Baseline and 3-7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacey L Schepens Niemiec, PhD principal investigator
University of Southern California Chan Division of OS-OT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FitSitt Prototype in people with Healthy Lifestyle, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present (time frame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025; AzTrials last refreshed its copy on 7 Nov 2026.