Metabolic Syndrome and Fall Risk
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|ClinicalTrials.gov Identifier: NCT02633891|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : August 17, 2022
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Autonomic Neuropathy||Behavioral: Balance exercise Behavioral: Standard care||Not Applicable|
Active, not recruiting due to COVID-19
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||parallel treatments|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||single blind|
|Official Title:||Metabolic Syndrome and Fall Risk|
|Actual Study Start Date :||January 2, 2017|
|Actual Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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
- 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.
- 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 an 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633891
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Lindsay A Zilliox, MD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|