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Metabolic Syndrome and Fall Risk

Primary Purpose

Metabolic Syndrome, Autonomic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance exercise
Standard care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring neuropathies, metabolic diseases, nervous system diseases, peripheral nervous system diseases

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balance exercise program

standard care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 15, 2015
Last Updated
March 29, 2023
Sponsor
VA Office of Research and Development
Collaborators
University of Maryland
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1. Study Identification

Unique Protocol Identification Number
NCT02633891
Brief Title
Metabolic Syndrome and Fall Risk
Official Title
Metabolic Syndrome and Fall Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
March 28, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of Maryland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Autonomic Neuropathy
Keywords
neuropathies, metabolic diseases, nervous system diseases, peripheral nervous system diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel treatments
Masking
Outcomes Assessor
Masking Description
single blind
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance exercise program
Arm Type
Experimental
Arm Description
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.
Arm Title
standard care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Balance exercise
Intervention Description
tailored balance exercise program
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
general health education and fall prevention classes
Primary Outcome Measure Information:
Title
Four Square Step Test (FSST)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Dynamic Gait Index (DGI)
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsay A Zilliox, MD
Organizational Affiliation
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Metabolic Syndrome and Fall Risk

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