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Metabolic Syndrome and Fall Risk

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ClinicalTrials.gov Identifier: NCT02633891
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
University of Maryland, College Park
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Obesity and the metabolic syndrome (MetS) are rapidly growing problems. Individuals with the MetS are at risk for not only future chronic diseases, but they have a higher prevalence of neuropathy, including cardiac autonomic neuropathy, and have a higher incidence of falls. Currently there are no effective therapies to prevent or reverse the neuropathy seen in the MetS or to reduced the fall risk in this population. This research project will determine if a tailored balance exercise program will have functional benefits and result in a reduced fall risk in the growing population of patients with the MetS and neuropathy.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Autonomic Neuropathy Behavioral: Balance exercise Behavioral: Standard care Not Applicable

Detailed Description:
55 participants with evidence of the MetS and autonomic neuropathy will be assessed for fall risk with the Four Square Step Test (FSST), which is a measure of dynamic standing balance. Additional endpoints include the dynamic gait index. Measures of height, weight, and waist circumference will be taken and an oral glucose tolerance test as well as lipids and blood pressure will also be measured. Autonomic function will be measured using cardiac autonomic testing, quantitative sudomotor axon reflex test and tilt table testing. Participants will be randomized into either a standard care group that will receive fall risk education or a targeted balance exercise intervention group. Both groups will meet once a week. The intervention group will receive a 12 week balance program with personalized incremental increases in the amount and difficulty of each maneuver.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Metabolic Syndrome and Fall Risk
Actual Study Start Date : January 2, 2017
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Balance exercise program
Participants will attend weekly group training sessions and will keep an exercise log of home activity during a three month exercise program designed to improve balance. Balance exercises will be performed three times per week in a home-based training program.
Behavioral: Balance exercise
tailored balance exercise program

Active Comparator: standard care
Participants will meet in person on a weekly basis for a general education class regarding health and fall prevention but will not participate in an exercise class.
Behavioral: Standard care
general health education and fall prevention classes




Primary Outcome Measures :
  1. Four Square Step Test (FSST) [ Time Frame: 12 weeks ]
    A measure of proactive dynamic standing balance. A participant steps over four canes that are laid on the ground at 90 degree angles to each other. The participants stands in one of the squares formed by the canes and they are instructed to step as quickly as possible into each square in a specified sequence.


Secondary Outcome Measures :
  1. Dynamic Gait Index (DGI) [ Time Frame: 12 weeks ]
    An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking an it assesses an individual's ability to modify balance while walking in the presence of external demands (walking while changing speeds, head turns, stepping over and around obstacles, pivoting, and stair climbing).



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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • MetS at the time of screening based on the International Diabetes Federation definition
  • No risk factors for other causes of neuropathy
  • Autonomic neuropathy as defined by the Toronto Diabetic Neuropathy Expert Group 2010/11 consensus criteria
  • Age 45-75 years inclusive at the time of screening
  • Medically stable at the time of enrollment
  • Able to participate in a standing balance exercise program without constant standby monitoring
  • Women of childbearing potential must be using an acceptable method of contraception for the duration of their participation in the study
  • Willing to accept assignment to either training group
  • Willing and able to participate in the assigned intervention program

Exclusion Criteria:

  • Pregnant women, prisoners, institutionalized subjects and other at risk subjects
  • Etiology of neuropathy other than the MetS
  • History of severe medical conditions likely to shorten lifespan or alter ability to participate in the trial
  • Severe autonomic neuropathy that restricts daily function and the ability to participate in study interventions
  • An inability to understand or cooperate with the procedures of the trial or refusal to sign the informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633891


Contacts
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Contact: Lindsay A Zilliox, MD (410) 328-3100 lzilliox@som.umaryland.edu
Contact: Neda M Ilieva (410) 605-7000 Neda.Ilieva@va.gov

Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Recruiting
Baltimore, Maryland, United States, 21201
Contact: Lindsay A Zilliox, MD    410-328-3100    lzilliox@som.umaryland.edu   
Principal Investigator: Lindsay A Zilliox, MD         
Sponsors and Collaborators
VA Office of Research and Development
University of Maryland, College Park
Investigators
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Principal Investigator: Lindsay A Zilliox, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02633891     History of Changes
Other Study ID Numbers: F1651-W
1IK2RX001651-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
neuropathies
metabolic diseases
nervous system diseases
peripheral nervous system diseases

Additional relevant MeSH terms:
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Syndrome
Metabolic Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases