Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 50 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland 21201
Contact:
Lindsay A Zilliox, MD
410-328-3100
lzilliox@som.umaryland.edu

More Details

NCT ID
NCT02633891
Status
Recruiting
Sponsor
VA Office of Research and Development

Study Contact

Lindsay A Zilliox, MD
(410) 328-3100
lzilliox@som.umaryland.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.