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OpenTrials
Completed

NCT Number: NCT02633891

Metabolic Syndrome and Fall Risk

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.

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Key information

Conditions

Metabolic Syndrome Autonomic Neuropathy Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

About this study

Completed

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Balance exercise

Behavioral

tailored balance exercise program

Standard Care

Behavioral

general health education and fall prevention classes

Primary outcomes

  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 outcomes

  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 and 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).

    The short form DGI is scored 0-12, with higher number indicating better performance.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • University of Maryland

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Dec 17, 2015
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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