Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation

NCT03625349 | Active Not Recruiting DMC FDA Drug

• 2 other identifiers: E3207-RE1697-R
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Blood Flow Response to passive leg movement.

  Doppler ultrasound will be used to assess movement induced hyperemia in the femoral artery.

  This outcome measure will be assessed at each study visit through study completion, about 3.5 years.

Study Arms (1)

PLM participants

Participants who undergo passive leg movement, with and without LNMMA.

Drug: NG-Monomethyl-L-Arginine

Interventions

NG-Monomethyl-L-Arginine DRUG

Inhibitor of nitric oxide synthase.

Also known as: LNMMA

PLM participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will range from young healthy volunteers to patients undergoing angiography.

You may qualify if:

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

You may not qualify if:

• Young healthy subjects: Evidence of cardiovascular disease.
• Patients undergoing angiography: Poor kidney function.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148-0001, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

omega-N-Methylarginine

Intervention Hierarchy (Ancestors)

Arginine; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Russell S. Richardson, PhD

  VA Salt Lake City Health Care System, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 10, 2018
• Study Start: September 1, 2015
• Primary Completion (Estimated): October 29, 2027
• Study Completion (Estimated): October 29, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)