Clinical trial NCT05044299: Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population
Official title: Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sedentary Behavior
Aging
Keywords: aging
sedentary behavior
blood flow
device
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study has two arms comparing device with and without resistance load over equal period of operation
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* Self-reported sedentary behavior and physically inactive
* Activity level confirmed via questionnaire
* Activity level confirmed by wearing activity monitor (Actigraph) over 7 days

Exclusion Criteria:

* History of cardiopulmonary
* History of cardiovascular pathology
* History of musculoskeletal conditions
* Other pathology precluding light exercise as evaluated by licensed geriatrician

Primary outcomes:
measure: Blood flow
timeFrame: 15 minutes
Secondary outcomes:
measure: continuous heart rate
timeFrame: 15 minutes
measure: continuous blood pressure
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: David H Bradshaw, PhD
role: PRINCIPAL_INVESTIGATOR
References: