Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05044299
Status:
WITHDRAWN
Last Update Posted:
2023-08-24
First Post:
2021-09-01
Brief Title:
Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population
Status:
WITHDRAWN
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The project was not considered for funding so we scrapped the project
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 users 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 andor unwilling to engage in more rigorous physical activity
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 andor unwilling to engage in more rigorous physical activity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None