Sedentary BehaviorNCT05044299
Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population
A study testing Isoped in people with Sedentary Behavior and Aging, run by University of Utah.
Trial summary
The Isoped (patented) is a portable medical device that provides a safe and engaging opportunity for regular physical activity to those with limited mobility and difficulties with performing traditional exercise tasks. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Aging
- What is being tested?
- Isoped
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Self-reported sedentary behavior and physically inactive
- Activity level confirmed via questionnaire
- Activity level confirmed by wearing activity monitor (Actigraph) over 7 days
Who cannot join
- History of cardiopulmonary
- History of cardiovascular pathology
- History of musculoskeletal conditions
- Other pathology precluding light exercise as evaluated by licensed geriatrician
About this study
The Isoped (patented) is a portable medical device that provides a safe and engaging opportunity for regular physical activity to those with limited mobility and difficulties with performing traditional exercise tasks. It is a tool designed to encourage regular and repeated low impact movement of the lower extremities that can improve blood flow and lead to improved cardiovascular function. By restoring healthier cardiovascular tone, Isoped users may be able to progress to more demanding activities leading to a healthy lifestyle change. Experiencing these improvements can boost confidence, mood, and overall quality of life. Isoped users can exercise while sitting at a desk, watching television, or in a rehabilitation facility. The lightweight device sits on the floor beneath the user's feet and can be operated from a seated, reclined, or supine position. Circulation and lower extremities' blood flow increase as the feet slide the pedals in a forward and backward movement similar to a shuffling walk or in cross-country skiing. Resistance load can be controlled by the user for a customized experience using a smartphone app. Physical exercise is widely recommended as a primary treatment by physicians to improve circulation and prevent cardiovascular diseases associated with physical inactivity and a sedentary lifestyle. Isoped is a healthy and innovative alternative to pharmacological, surgical or other treatment modalities.
Read the detailed description
Aim 1, Refine Device Prototype: A prototype Isoped device will be refined and calibrated for use. Engineering challenges include refining the design to incorporate these features and functions: Electronic Resistance mode (adjustable wirelessly through the Graphical User Interface (GUI)); Stride Length Adjustment (through the GUI); Stride Width Adjustment; Incline Adjustment (powered or manual); Footpad rotation and removal; Bluetooth connectivity to the GUI; comfortable stabilizing modifications to footpads.
Aim 2, Evaluate Device Efficacy and Safety: Isoped will be evaluated for safety and efficacy in a pilot clinical study of 40 volunteers aged 65 to 85 meeting criteria for a sedentary lifestyle and limited physical activity. To non-invasively determine the peripheral hemodynamic effect of the Isoped, we will quantify the lower extremity blood flow response to Isoped facilitated lower leg movement using doppler ultrasound measured at the femoral artery. Changes in mean blood pressure and heart rate will provide secondary measures of effect. Participant safety will be monitored using a 12-lead ECG and beat-by-beat measures of blood pressure and cardiac output. Device performance and safety will be evaluated by recording any deviations in device operability and any adverse events.
On completion of Phase 1, Phase 2 funding will provide the means to further evaluate the device for use in a patient population as a means for encouraging progression to regular health improving exercise regimens. A planned clinical trial in frail and sedentary aging persons using the Isoped over a period of several weeks will evaluate health improvement and willingness to engage in more demanding exercise regimens. This will position Isoped for commercialization as a tool for encouraging effective non-invasive, low-impact activity for improving the health and quality of life in a wide variety of patients having compromised circulation and who are unable and/or unwilling to engage in more rigorous physical activity.
- Conditions
- Sedentary Behavior, Aging
- Being tested
- Isoped
- Keywords
- aging, sedentary behavior, blood flow, device
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsopedDevice
Isoped is a mechanical device allowing movement of lower extremities in a forward and backward motion, with phone-based app to control resistance load
| Study group | Role | What they receive |
|---|---|---|
| Isoped mobilization with resistance load | Active comparator | Use of Isoped with movement at 3 levels of resistance load: zero, low, high, each condition lasts 3 minutes at 9 minutes total work Receives: Device: Isoped |
| Isoped mobilization without resistance load | Active comparator | Use of Isoped with movement at zero resistance load lasts 9 minutes of work Receives: Device: Isoped |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood flow
blood flow measured at femoral artery using doppler ultrasound
Measured: 15 minutes
Secondary outcomes (2)
continuous heart rate
heart rate measured using Finapres
Measured: 15 minutes
continuous blood pressure
systolic, diastolic, and mean blood pressure measured continuously (Finapres)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Apr 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Why it stopped: The project was not considered for funding so we scrapped the project.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study has two arms comparing device with and without resistance load over equal period of operation
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Bradshaw, University of Utah
- Investigators
- David H Bradshaw, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044299
- Sponsor's protocol ID
- IsopedPhase1
- Status last verified
- Aug 2023
- First submitted
- 1 Sep 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population
- ClinicalTrials.gov ID
- NCT05044299
- Acronym / sponsor ID
- IsopedPhase1
- Conditions
- Sedentary Behavior, Aging
- Keywords
- aging, sedentary behavior, blood flow, device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project was not considered for funding so we scrapped the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Isoped (patented) is a portable medical device that provides a safe and engaging opportunity for regular physical activity to those with limited mobility and difficulties with performing traditional exercise tasks. It is a tool designed to encourage regular and repeated low impact movement of the lower extremities that can improve blood flow and lead to improved cardiovascular function. By restoring healthier cardiovascular tone, Isoped users may be able to progress to more demanding activities leading to a healthy lifestyle change. Experiencing these improvements can boost confidence, mood, and overall quality of life. Isoped users can exercise while sitting at a desk, watching television, or in a rehabilitation facility. The lightweight device sits on the floor beneath the user's feet and can be operated from a seated, reclined, or supine position. Circulation and lower extremities' blood flow increase as the feet slide the pedals in a forward and backward movement similar to a shuffling walk or in cross-country skiing. Resistance load can be controlled by the user for a customized experience using a smartphone app. Physical exercise is widely recommended as a primary treatment by physicians to improve circulation and prevent cardiovascular diseases associated with physical inactivity and a sedentary lifestyle. Isoped is a healthy and innovative alternative to pharmacological, surgical or other treatment modalities.
Detailed description
Aim 1, Refine Device Prototype: A prototype Isoped device will be refined and calibrated for use. Engineering challenges include refining the design to incorporate these features and functions: Electronic Resistance mode (adjustable wirelessly through the Graphical User Interface (GUI)); Stride Length Adjustment (through the GUI); Stride Width Adjustment; Incline Adjustment (powered or manual); Footpad rotation and removal; Bluetooth connectivity to the GUI; comfortable stabilizing modifications to footpads.
Aim 2, Evaluate Device Efficacy and Safety: Isoped will be evaluated for safety and efficacy in a pilot clinical study of 40 volunteers aged 65 to 85 meeting criteria for a sedentary lifestyle and limited physical activity. To non-invasively determine the peripheral hemodynamic effect of the Isoped, we will quantify the lower extremity blood flow response to Isoped facilitated lower leg movement using doppler ultrasound measured at the femoral artery. Changes in mean blood pressure and heart rate will provide secondary measures of effect. Participant safety will be monitored using a 12-lead ECG and beat-by-beat measures of blood pressure and cardiac output. Device performance and safety will be evaluated by recording any deviations in device operability and any adverse events.
On completion of Phase 1, Phase 2 funding will provide the means to further evaluate the device for use in a patient population as a means for encouraging progression to regular health improving exercise regimens. A planned clinical trial in frail and sedentary aging persons using the Isoped over a period of several weeks will evaluate health improvement and willingness to engage in more demanding exercise regimens. This will position Isoped for commercialization as a tool for encouraging effective non-invasive, low-impact activity for improving the health and quality of life in a wide variety of patients having compromised circulation and who are unable and/or unwilling to engage in more rigorous physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study has two arms comparing device with and without resistance load over equal period of operation
| Arm | Type | Receives |
|---|---|---|
| Isoped mobilization with resistance load | Active comparator | Device: IsopedUse of Isoped with movement at 3 levels of resistance load: zero, low, high, each condition lasts 3 minutes at 9 minutes total work |
| Isoped mobilization without resistance load | Active comparator | Device: IsopedUse of Isoped with movement at zero resistance load lasts 9 minutes of work |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Self-reported sedentary behavior and physically inactive
- Activity level confirmed via questionnaire
- Activity level confirmed by wearing activity monitor (Actigraph) over 7 days
Key exclusion criteria (4 listed)
- History of cardiopulmonary
- History of cardiovascular pathology
- History of musculoskeletal conditions
- Other pathology precluding light exercise as evaluated by licensed geriatrician
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 |
|---|---|---|
| IsopedIsoped is a mechanical device allowing movement of lower extremities in a forward and backward motion, with phone-based app to control resistance load | Device | Isoped mobilization with resistance load, Isoped mobilization without resistance load |
Primary outcome
Blood flow
Time frame: 15 minutes
blood flow measured at femoral artery using doppler ultrasound
2 secondary outcomes
continuous heart rate
Time frame: 15 minutes
continuous blood pressure
Time frame: 15 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No
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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.
David H Bradshaw, PhD principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Isoped in people with Sedentary Behavior and Aging, run by University of Utah.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood flow (time frame: 15 minutes). 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 Aug 2023.