Metabolic Syndrome and Fall Risk

NCT ID: NCT02633891

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-02
• Study Completion Date: 2022-03-28

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

Completed

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.

Conditions

Metabolic Syndrome; Autonomic Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Balance exercise

Intervention Type: BEHAVIORAL

tailored balance exercise program

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.

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: BEHAVIORAL

general health education and fall prevention classes

Interventions

Balance exercise

tailored balance exercise program

Intervention Type: BEHAVIORAL

Standard care

general health education and fall prevention classes

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay A Zilliox, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1IK2RX001651-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

F1651-W

Identifier Type: -

Identifier Source: org_study_id