Metabolic Syndrome and Fall Risk
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02633891|
Recruitment Status : Recruiting
First Posted : December 17, 2015
Last Update Posted : May 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Autonomic Neuropathy||Behavioral: Balance exercise Behavioral: Standard care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Metabolic Syndrome and Fall Risk|
|Actual Study Start Date :||January 2, 2017|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||December 31, 2021|
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
|Contact: Lindsay A Zilliox, MD||(410) firstname.lastname@example.org|
|Contact: Neda M Ilieva||(410) 605-7000||Neda.Ilieva@va.gov|
|United States, Maryland|
|Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Lindsay A Zilliox, MD 410-328-3100 email@example.com|
|Principal Investigator: Lindsay A Zilliox, MD|
|Principal Investigator:||Lindsay A Zilliox, MD||Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD|