Healthy Lifestyle
Conditions
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.
Interventions
DEVICEFitSitt 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.
Sponsors
National Institute on Aging (NIA)
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 65 years old or older 2. English-speaking 3. Live in local Los Angeles area and no plans to vacation away from home during the trial period 4. Self-reported ability to safely engage in 30 minutes of light-intensity activity per day 5. Self-reported ability to pedal comfortably without stopping for 5 minutes 6. Community-dwelling
Exclusion criteria
1. Dependence in transferring to a chair safely 2. Inability to safely and reliably access and operate FitSitt (ascertained by a brief demonstration at beginning of in-home visit) 3. A member living in the same household participated in the in-home testing stage of this study 4. Participated in the in-lab testing stage of the study already 5. Unstable health conditions such as uncontrolled blood pressure, end-stage renal failure on renal replacement therapy, or malignancy currently on chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Physical Activity Change From Baseline to 3-7 Days | 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. |
| Self-reported Fatigue Severity Change From Baseline to 3-7 Days | 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). |
| Self-reported Pain Severity Change From Baseline to 3-7 Days | 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. |
| Self-reported Pain Interference Change From Baseline to 3-7 Days | 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. |
| 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 | 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. |
| FitSitt Seat Occupancy Usage Behavior | 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. |
| FitSitt Pedaling Usage Behavior | 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. |
| FitSitt Use Self-efficacy | 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. |
| Fatigue Interference Change | 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). |
| Self-reported Joint Stiffness Change From Baseline to 3-7 Days | 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 |
Countries
United States
Participant flow
Recruitment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | In-home Feasibility Test |
|---|---|
| Age, Continuous | 73 years |
| Confidence using a smartphone | 7 units on a scale |
| Daily hours reported watching TV | 3 Hours/day |
| Health conditions Arthritis | 9 participants |
| Health conditions Cancer | 4 participants |
| Health conditions Diabetes (I or II) | 3 participants |
| Health conditions High blood pressure | 5 participants |
| Health conditions High cholesterol | 5 participants |
| Health conditions Osteoporosis / osteopenia | 5 participants |
| Race/Ethnicity, Customized Race/ethnicity Asian | 4 Participants |
| Race/Ethnicity, Customized Race/ethnicity Latino/Hispanic | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic Black | 2 Participants |
| Race/Ethnicity, Customized Race/ethnicity Non-Hispanic White | 7 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
| Smartphone operating system Android | 3 Participants |
| Smartphone operating system iOS | 8 Participants |
| Years of smartphone ownership | 13 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 1 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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.
Time frame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| In-home Feasibility Test | Daily Prolonged Sedentary Bouts (activPAL+FitSitt Sensors) Change From Baseline to up to 7 Days With Intervention Present | -1.7100 hours/24-hr period |
p-value: 0.007Wilcoxon (Mann-Whitney)
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.
Time frame: Intervention-present monitoring period (3-7days) relative to pre-intervention 72-hour baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Daily Steps Change From Baseline to up to 7 Days With Intervention Present | 3142.88 steps per day | Standard Deviation 5277.55 |
p-value: 0.07495% CI: [-297.76522, 5604.07522]t-test, 2 sided
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).
Time frame: Baseline and 3-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Fatigue Interference Change | -0.51 score on a scale | Standard Deviation 1.45 |
p-value: 0.16895% CI: [-1.53867, 0.29467]t-test, 2 sided
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.
Time frame: From baseline through 3-7 days (daily)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | FitSitt Pedaling Usage Behavior | 101.3 minutes per day | Standard Deviation 65.95 |
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.
Time frame: From baseline through 3-7 days (daily)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | FitSitt Seat Occupancy Usage Behavior | 214.20 minutes per day | Standard Deviation 139.22 |
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.
Time frame: 3-7 days (post-intervention)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | FitSitt Use Self-efficacy | 7.66 score on a scale | Standard Deviation 2.58 |
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).
Time frame: Baseline and 3-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Self-reported Fatigue Severity Change From Baseline to 3-7 Days | -0.51 score on a scale | Standard Deviation 1.45 |
p-value: 0.19195% CI: [-1.31374, 0.28841]t-test, 2 sided
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
Time frame: Baseline and 3-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Self-reported Joint Stiffness Change From Baseline to 3-7 Days | 0.0013 percent | Standard Deviation 0.10148 |
p-value: 0.9695% CI: [-0.05486, 0.5753]t-test, 2 sided
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.
Time frame: Baseline and 3-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Self-reported Pain Interference Change From Baseline to 3-7 Days | -0.92 score on a scale | Standard Deviation 2.19 |
p-value: 0.12595% CI: [-2.13898, 0.29098]t-test, 2 sided
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.
Time frame: Baseline and 3-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Self-reported Pain Severity Change From Baseline to 3-7 Days | -0.45 score on a scale | Standard Deviation 1.35 |
p-value: 0.21895% CI: [-1.19775, 0.29775]t-test, 2 sided
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.
Time frame: Baseline and 3-7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-home Feasibility Test | Self-reported Physical Activity Change From Baseline to 3-7 Days | 4.44 score on a scale | Standard Deviation 41.59 |
p-value: 0.68595% CI: [-18.59116, 27.47249]t-test, 2 sided