Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation
Brief Summary: Current U.S. Veteran demographics reveal an aging population with significant cardiovascular dysfunction. This ultimately manifests as mobility limitation, inactivity, and a subsequent worsening of cardiovascular disease (CVD) that often leads to death. However, despite this clear negative cycle of events, there is not a single clinically accepted, and therefore routinely utilized, method of assessing vascular health. As nitric oxide (NO) is anti-atherogenic and cardioprotective, identifying an in vivo bioassay of NO bioavailability has significant worth in this arena. Fueled predominantly by the VA Merit Award prior to this renewal application, single passive leg movement (sPLM) and the subsequent blood flow increase, measured non-invasively by ultrasound Doppler in the common femoral artery, is emerging as a method by which vascular endothelial function and therefore NO bioavailability can be determined. However, although this work has yielded an initial characterization of sPLM and established this method to be a novel, valid, and a clinically relevant approach to determine vascular health, further understanding of the sPLM response with advancing age and, ultimately, its implementation and assessment in both rehabilitation and clinical arenas is still necessary. With the growing interest in personalized medicine, the development of tools, such as sPLM, that allow individualized assessments to guide the physician, the patient, and the rehabilitative team, are essential. Therefore, two specific aims are proposed that will address the Central Hypothesis that the sPLM paradigm provides a clinically meaningful assessment of endothelial function. First, cardiac rehabilitation will be assessed by sPLM in the elderly, and, coupled with studies in the young, will elucidate the predominant pathways responsible for the change in endothelial function with aging and rehabilitation. Second, the CVD diagnostic value of the sPLM assessment of endothelial function will be evaluated relative to classic measures and markers of subclinical disease in order accelerate the inclusion of endothelial dysfunction as a CVD risk factor. The proposed studies aim to catalyze the transition of the assessment of endothelial function by sPLM from research to clinical practice.
Conditions:
🦠 Aging 🦠 Cardiovascular Disease
🗓️ Study Start (Actual) 1 September 2015
🗓️ Primary Completion (Estimated) 31 October 2025
✅ Study Completion (Estimated) 31 October 2025
👥 Enrollment (Estimated) 130
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Salt Lake City, Utah, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Young healthy subjects: No evidence of cardiovascular disease.
    • * Patients undergoing angiography: Clinical referral for an angiography.

    Exclusion Criteria:

    • * Young healthy subjects: Evidence of cardiovascular disease.
    • * Patients undergoing angiography: Poor kidney function.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 July 2018
  • First Submitted that Met QC Criteria 8 August 2018
  • First Posted 10 August 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024