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Completed

NCT Number: NCT05510297

Active Seating System to Lessen Sedentariness 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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90089, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Self-reported Physical Activity Change From Baseline to 3-7 Days

    Time frame: Baseline and 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.

  3. Self-reported Fatigue Severity Change From Baseline to 3-7 Days

    Time frame: Baseline and 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).

  4. Self-reported Pain Severity Change From Baseline to 3-7 Days

    Time frame: Baseline and 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.

  5. Self-reported Pain Interference Change From Baseline to 3-7 Days

    Time frame: Baseline and 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.

  6. Self-reported Joint Stiffness Change From Baseline to 3-7 Days

    Time frame: Baseline and 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

  7. FitSitt Seat Occupancy Usage Behavior

    Time frame: From baseline through 3-7 days (daily)

    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.

  8. FitSitt Pedaling Usage Behavior

    Time frame: From baseline through 3-7 days (daily)

    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.

  9. FitSitt Use Self-efficacy

    Time frame: 3-7 days (post-intervention)

    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.

  10. Fatigue Interference Change

    Time frame: Baseline and 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).

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2022
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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