Metabolic Syndrome and Fall Risk
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Endocrine |
| Therapuetic Areas: | Endocrinology, Neurology |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 12/20/2018 |
| Start Date: | January 2, 2017 |
| End Date: | December 31, 2020 |
| Contact: | Lindsay A Zilliox, MD |
| Email: | lzilliox@som.umaryland.edu |
| Phone: | (410) 328-3100 |
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.
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.
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.
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.
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 50-70 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
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Lindsay A Zilliox, MD
Phone: 410-328-3100
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