Metabolic Syndrome and Fall Risk

NCT02633891 | Completed Results DMC

• 2 other identifiers: F1651-W1IK2RX001651-01A2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Autonomic Neuropathy

Keywords

neuropathies; metabolic diseases; nervous system diseases; peripheral nervous system diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Dynamic Gait Index (DGI)

  12 weeks

Study Arms (2)

Balance exercise program

EXPERIMENTAL

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

standard care

ACTIVE COMPARATOR

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

Interventions

Balance exercise BEHAVIORAL

tailored balance exercise program

Balance exercise program

Standard care BEHAVIORAL

general health education and fall prevention classes

standard care

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland: collaborator

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Metabolic Diseases; Nervous System Diseases; Peripheral Nervous System Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Lindsay Zilliox
• Organization: BVAMC

lzilliox@som.umaryland.edu

410-328-3100

Study Officials

• Lindsay A Zilliox, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: parallel treatments

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: January 2, 2017
• Primary Completion: March 28, 2022
• Study Completion: March 28, 2022
• Last Updated: June 28, 2024
• Results First Posted: June 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)