Development of the Isoped Device for Increasing Blood Flow in a Sedentary Aging Population

NCT05044299 | Withdrawn DMC

• 1 other identifier: IsopedPhase1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sedentary Behavior; Aging

Keywords

aging; sedentary behavior; blood flow; device

Outcome Measures

Primary Outcomes (1)

• Blood flow

  blood flow measured at femoral artery using doppler ultrasound

  15 minutes

Secondary Outcomes (2)

• continuous heart rate

  15 minutes

• continuous blood pressure

  15 minutes

Study Arms (2)

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

Device: Isoped

Isoped mobilization without resistance load

ACTIVE COMPARATOR

Use of Isoped with movement at zero resistance load lasts 9 minutes of work

Device: Isoped

Interventions

Isoped DEVICE

Isoped is a mechanical device allowing movement of lower extremities in a forward and backward motion, with phone-based app to control resistance load

Isoped mobilization with resistance load; Isoped mobilization without resistance load

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• David H Bradshaw, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct research assistant professor

Model Details: Study has two arms comparing device with and without resistance load over equal period of operation

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 14, 2021
• Study Start: April 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: March 31, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share