Metabolic Syndrome, Autonomic Neuropathy
Conditions
Keywords
neuropathies, metabolic diseases, nervous system diseases, peripheral nervous system diseases
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.
Interventions
BEHAVIORALBalance exercise
tailored balance exercise program
BEHAVIORALStandard care
general health education and fall prevention classes
Sponsors
University of Maryland
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
single blind
Intervention model description
parallel treatments
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Four Square Step Test (FSST) | 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Dynamic Gait Index (DGI) | 12 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Balance exercise: tailored balance exercise program | 7 |
| 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.
Standard care: general health education and fall prevention classes | 5 |
| Total | 12 |
Baseline characteristics
| Characteristic | Standard Care | Total | Balance Exercise Program |
|---|---|---|---|
| Age, Continuous | 66 years | 66 years | 66 years |
| BMI | 38.16 kg/m^2 | 36.69 kg/m^2 | 35.64 kg/m^2 |
| Dynamic Gait Index (DGI) | 9 score on a scale | 7.73 score on a scale | 7 score on a scale |
| Fasting glucose | 108.4 mg/dL | 123.25 mg/dL | 133.86 mg/dL |
| Four square step test | 13.01 seconds | 13.91 seconds | 14.49 seconds |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 7 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 5 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 7 | 0 / 5 |
Outcome results
Primary
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
Population: In the balance exercise program 2 participants were lost to follow up and 2 participants did not complete the 12-week mobility testing, which included the FSST.~In the standard care group 1 participant was lost to follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Balance Exercise Program | Four Square Step Test (FSST) | 11.04 seconds |
| Standard Care | Four Square Step Test (FSST) | 14.29 seconds |
Secondary
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
Population: In the balance exercise program 2 participants were lost to follow up and 2 participants did not complete the 12-week mobility testing, which included the DGI.~In the standard care group 1 participant was lost to follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Balance Exercise Program | Dynamic Gait Index (DGI) | 9.33 score on a scale |
| Standard Care | Dynamic Gait Index (DGI) | 7.5 score on a scale |