Metabolic Syndrome and Fall Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Four Square Step Test (FSST)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
single blind
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Four Square Step Test (FSST)
时间窗: 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.
次要结局
- Dynamic Gait Index (DGI)(12 weeks)