Clinical trial NCT02633891: Metabolic Syndrome and Fall Risk
Official title: Metabolic Syndrome and Fall Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Autonomic Neuropathy
Keywords: neuropathies
metabolic diseases
nervous system diseases
peripheral nervous system diseases
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Maryland
First posted: 2015-12-17
Enrollment: 12
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel treatments
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Four Square Step Test (FSST)
timeFrame: 12 weeks
Secondary outcomes:
measure: Dynamic Gait Index (DGI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Lindsay A Zilliox, MD
role: PRINCIPAL_INVESTIGATOR
References: