An interventional study of Balance exercise and Standard care in Metabolic Syndrome and Autonomic Neuropathy, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 12 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
tailored balance exercise program
general health education and fall prevention classes
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.
Time frame: 12 weeks
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 and 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). The short form DGI is scored 0-12, with higher number indicating better performance.
Time frame: 12 weeks
| Milestone | Balance Exercise Program | Standard Care |
|---|---|---|
| Started | 7 | 5 |
| Completed | 5 | 4 |
| Not completed | 2 | 1 |
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.
| seconds | Balance Exercise Program | Standard Care |
|---|---|---|
| Four Square Step Test (FSST) | 11.04 (9.9 to 12.93) | 14.29 (9.28 to 25.47) |
An instrumented DGI will be performed on an instrumented gait mat. The DGI is a measure of functional balance during walking and 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). The short form DGI is scored 0-12, with higher number indicating better performance.
| score on a scale | Balance Exercise Program | Standard Care |
|---|---|---|
| Dynamic Gait Index (DGI) | 9.33 (8 to 10) | 7.5 (3 to 11) |
Collected over 3 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Balance Exercise Program | 0/7 (0%) | 0/7 (0%) | — |
| Standard Care | 0/5 (0%) | 0/5 (0%) | — |
| Age, Continuous(years) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| Mean | 66 (53 to 74) | 66 (59 to 75) | 66 (53 to 75) |
| Sex: Female, Male(Participants) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 4 | 3 | 7 |
| Race (NIH/OMB)(Participants) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 |
| White | 4 | 3 | 7 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| BMI(kg/m^2) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| Mean | 35.64 (26.5 to 49.2) | 38.16 (29.9 to 47.4) | 36.69 (26.5 to 49.2) |
| Fasting glucose(mg/dL) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| Mean | 133.86 (97 to 203) | 108.4 (91 to 130) | 123.25 (91 to 203) |
| Four square step test(seconds) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| Mean | 14.49 (8.62 to 31.56) | 13.01 (8.15 to 22.6) | 13.91 (8.15 to 31.56) |
| Dynamic Gait Index (DGI)(score on a scale) | Balance Exercise Program | Standard Care | Total |
|---|---|---|---|
| Mean | 7 (3 to 9) | 9 (5 to 12) | 7.73 (3 to 12) |
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