N/A
N=12
Metabolic Syndrome and Fall Risk
Metabolic Syndrome · Autonomic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT02633891 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Four Square Step Test (FSST) — 11.04; 14.29 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Balance exercise (Behavioral); Standard care (Behavioral)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Four Square Step Test (FSST) |
11.04; 14.29 | — |
| SECONDARY Dynamic Gait Index (DGI) |
9.33; 7.5 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02633891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.