Metabolic Syndrome and Fall Risk

Metabolic Syndrome Clinical Trial

Official title:

Metabolic Syndrome and Fall Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633891
• Other study ID #: F1651-W
• Secondary ID: 1IK2RX001651-01A
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: March 28, 2022

Study information

• Verified date: March 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 28, 2022
• Est. primary completion date: March 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Neuropathy
• Metabolic Syndrome
• Syndrome

Intervention

Behavioral:
• Balance exercise
tailored balance exercise program
• Standard care
general health education and fall prevention classes

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Four Square Step Test (FSST)	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.	12 weeks
Secondary	Dynamic Gait Index (DGI)	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).	12 weeks