NCT03266510已完成不适用
Inspiratory Muscle Strength Training to Improve Blood Pressure and Physiological Function
Douglas Seals2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
The purpose of this study is to assess the efficacy of inspiratory muscle strength training for lowering blood pressure and improving physiological function (vascular, motor, and cognitive) in middle-aged and older adults with elevated systolic blood pressure.
详细描述
Over, the proposed research project has the long-term potential to influence clinical practice by establishing a novel lifestyle intervention for treating multiple domains of age- and hypertension-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent
- •Willing to accept random assignment to condition
- •Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
- •Resting systolic blood pressure 120-159 mmHg
- •Resting diastolic blood pressure <100 mmHg
- •Subjects taking anti-hypertensive medications will be included provided they meet the other inclusion criteria, including elevated systolic blood pressure. These medications will not be withheld prior to experimental protocols.
- •Free from alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual or Mental Disorders (DSM-IV)
排除标准
- •Current smoking
- •Chronic clinical disease (e.g., inflammatory bowel disease/irritable bowel syndrome, coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive function [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia, or other brain diseases of aging]), except hypertension
- •Postmenopausal <1 year
- •Scoring <21 on the mini-mental state examination
- •Moderate or sever peripheral artery disease (ankle-brachial index 0.7)
- •Taking a medication that your doctor deems unsafe to hold for >1 week
- •A graded exercise test will be performed by all subjects. If there is physician concern or an adverse event, the subject will not participate in the study.
- •No weight stable in the prior 3 months (>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function)
结局指标
主要结局
Blood pressure
时间窗: 6 weeks
Resting blood pressure
次要结局
- Ambulatory blood pressure(6 weeks)
- Endothelium-dependent dilation(6 weeks)
- Arterial stiffness(6 weeks)
- Motor function(6 weeks)
- Cognitive function(6 weeks)
- Systemic markers of oxidative stress(6 weeks)
- Endothelial cell markers of oxidative stress(6 weeks)
研究者
Douglas Seals
Professor of Distinction
University of Colorado, Boulder
研究点 (2)
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