NCT02633891

Metabolic Syndrome and Fall Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome
• Autonomic Neuropathy

Interventions

Type	Name	Description
BEHAVIORAL	Balance exercise	tailored balance exercise program
BEHAVIORAL	Standard care	general health education and fall prevention classes

Timeline

• Start date: 2017-01-02
• Primary completion: 2022-03-28
• Completion: 2022-03-28
• First posted: 2015-12-17
• Last updated: 2024-06-28
• Results posted: 2024-06-28

Locations

1 site across 1 country: United States