The Use of a Home-based Walking Program to Treat Orthostatic Hypotension in Older Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Pulse wave velocity (central and peripheral)
研究概览
简要总结
Older persons with diabetes have a harder time maintaining blood pressure when standing up. When blood pressure drops when standing up, fainting may occur. This study will see how regular exercise can improve the ability of the body to keep blood pressure up when standing. We want to see how this improvement varies with a home-based walking program.
详细描述
Detailed Summary
- PURPOSE: Older adults with diabetes faint frequently, due to an impairment in the cardiovascular control mechanisms (arterial baroreceptor function, autonomic nervous system function and cerebral autoregulation) that prevent syncope. The purpose of this study is to examine the ability of a home based walking program to reverse these impairments.
- HYPOTHESES: a) A home-based walking program will improve the compensatory cardiovascular responses that prevent syncope in older adults with Type 2 diabetes. A moderate, regular exercise program will:
- increase arterial baroreflex sensitivity
- increase heart rate variability (marker of autonomic nervous system function)
- decrease cerebrovascular resistance
- improve cerebral autoregulation during upright tilt. b) There will be relationship between the improvement in compensatory cardiovascular responses and regular exercise.
c) Design of more practicable training prescriptions than that used in a research setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes for at least 5 years treated with diet alone or oral agents
- •Nonsmoker for at least 5 years
- •Subjects must be sedentary (as defined by no strength training and less than 30 minutes brisk walking/moderate exercise per week and no vigorous exercise in the preceding 6 months)
- •All subjects will have a fasting glucose of <12 mM and a hemoglobin A1c < 8.5%
- •Orthostatic hypotension defined as a decrease in systolic blood pressure of at least 20 mm Hg or diastolic blood pressure of at least 10 mm Hg within 3 minutes of assuming an upright posture on the initial screening visit as per current American Academy of Neurology guidelines.
排除标准
- •Abnormalities on complete blood count, electrolytes or creatinine, on resting ECG, treadmill exercise stress test
- •Significant pulmonary, exercise-limiting orthopedic or neurological impairment
- •Evidence of valvular disease, exercise-induced syncope, angina, arrhythmias or peripheral vascular disease
- •Poor blood pressure control as defined as systolic blood pressure greater than or equal to 160 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg
- •Total cholesterol/HDL cholesterol greater than or equal to 5.0 or LDL cholesterol greater than or equal to 4.21 mmol/L
- •Peripheral neuropathy severe enough to cause discomfort (for safety reasons)
- •Overt diabetic nephropathy excluding subjects with a urine albumin to creatinine ratio of greater than 2.0 in men or 2.8 in women
- •Diabetic retinopathy
研究组 & 干预措施
Control Phase; Exercise Phase
Participants act as their own control.
Control Phase:
Participants will not change their activity during the 3 month control phase (defined as no strength training and less than 30 minutes brisk walking/moderate exercise per week, no vigorous exercise) Baseline measures will be obtained.
Exercise Phase:
This phase will consist of a Titration phase followed by an Intervention Phase. During the Titration phase, under the guidance of a trainer, subjects will increase their number of steps by 20% per week until they have reached 10,000 steps or 3 months have passed. During the Intervention Phase subjects will continue to walk 10,000 steps (or the number of steps they reached in the Titration phase).
干预措施: Control Phase; Exercise Phase (Behavioral)
结局指标
主要结局
Pulse wave velocity (central and peripheral)
时间窗: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in middle cerebral artery velocity with upright tilting
时间窗: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Drop in blood pressure with upright tilt
时间窗: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
Arterial baroreflex sensitivity
时间窗: Measured at Baseline, 3 months after control phase and after 3 months of Intervention phase
次要结局
- Fasting blood glucose, HgbA1C(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- VO2max(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- Dynamometry measures of muscle strength(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- Resting and maximal heart rate(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- Lean body mass/% fat(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- Catecholamines(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- Increase in Gosling's pulsatility index(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
- Waist to hip ratio, BMI(Measured at Baseline, 3 month after control phase and after 3 months of Intervention phase.)
研究者
Kenneth Madden
Head, VGH Division of Geriatric Medicine
University of British Columbia