Maintenance Dose of Inspiratory Muscle Strength Training to Preserve Cardiovascular Adaptations
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) resting systolic blood pressure
研究概览
简要总结
This clinical research study will investigate the dose of inspiratory muscle strength training needed to maintain cardiovascular adaptations induced by a six-week loading dose.
详细描述
Cardiovascular disease (CVD) is the leading cause of death in the US and worldwide. Although it is well-known that lifestyle changes (e.g., diet, exercise) lower blood pressure (BP) and risk for cardiovascular events, an estimated ~98% of US adults with above-normal BP do not adhere to the recommended lifestyle behaviors. Common barriers to exercise, including lethargy, low exercise self-efficacy, fear of exercise-related pain, and lack of time, make adherence to traditional exercise strategies particularly difficult. The need for novel/different forms of exercise that are i) time-efficient, ii) well-tolerated, and iii) effective has never been greater.
Inspiratory muscle strength training (IMST) is a novel, time-efficient respiratory exercise, comprising just 5 sets of 6 inspiratory efforts with 1-minute rests between sets. This training takes just 5 mins/day, 5 sessions/wk, for a total weekly training time of 25-30 minutes. Distinct from other forms of traditional aerobic or high-intensity interval-type exercise, IMST is performed on a hand-held device in sitting or standing. Participants make repeated inspiratory efforts against a resistance and generate large negative pressures that are 2-4-fold greater than those generated during rest breathing, deep breathing, or high-intensity aerobic exercise. The investigators have shown that IMST performed 5 days/wk for 6 weeks, lowers SBP 9 ± 1 mmHg on average.
It is well known that exercise-induced adaptations plateau over time, despite increases in volume and/or intensity. Accordingly, the goal of exercise is not only to improve health, but to maintain health adaptations long term. Importantly, the dose of exercise required to improve health/performance is higher than the dose required to maintain health/performance. Given that lack of time is the most often cited reason for adults failing to initiate exercise and stopping chronic exercise participation, it is essential that any potential participant 1) appreciate the relationship between time spent exercising and health improvements and 2) understand how much exercise is needed to preserve exercise-induced adaptations to ensure an unnecessary amount of time is devoted to exercise. The investigators have shown that 6 weeks of IMST can significantly lower BP and improve respiratory strength, however, the dose needed to preserve these adaptations is unknown.
This study comprises a 6-week loading dose of IMST (5 days/week; Endpoint 1), followed by 12 weeks of IMST at a reduced dose (0, 1, or 3 days/week; Endpoint 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Due to the nature of the study groups, blinding is not possible.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •50+ years of age
- •systolic blood pressure between 120-169 mmHg
- •stable dose of medication (three months on the same dose)
- •weight stable in the prior 3 months (<3.0 kg weight change) and willing to remain weight stable throughout the study
- •absence of unstable clinical disease as determined by medical history
- •owns a smartphone
排除标准
- •current smoker (including tobacco products, vaping devices, THC, etc...)
- •have an uncontrolled medical condition (e.g., cancer)
- •myocardial infarction or stroke within the previous 12 months
- •performs regular aerobic exercise (>4 bouts/week)
- •BMI ≥ 40 kg/m2
- •systolic blood pressure <120 or ≥170 mmHg
- •diastolic blood pressure >100 or <60 mmHg
- •Cheyne-Stokes respiration
- •history of perforated eardrum
- •history of glaucoma or retinopathy
- •history of collapsed lung
- •diagnosed with asthma
- •pregnant, breastfeeding, or trying to become pregnant (self-reported)
- •medications that, in the opinion of the study physician, may impact the outcomes of the study (e.g., steroids)
- •does not own a smartphone or is unwilling to download the required application
结局指标
主要结局
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) resting systolic blood pressure
时间窗: Blood pressure will be assessed after 6 weeks of training and after an additional 12 weeks of training
Systolic blood pressure (SBP) will be measured by absolute change from endpoint 1. SBP will be assessed as described in Outcome 1.
Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
时间窗: EDD will be assessed after 6 weeks of training and after an additional 12 weeks of training
EDD will be assessed as described in Outcome 3
Change from baseline to endpoint 1 (6 weeks) resting systolic blood pressure
时间窗: Blood pressure will be assessed at baseline and after 6 weeks of training
Systolic blood pressure (SBP) will be measured by absolute change from baseline. SBP will be assessed in accordance with American College of Cardiology/American Heart Association guidelines. Measurements will be taken using an automated oscillometric sphygmomanometer and will be performed in triplicate over the brachial artery of the left arm after 5 minutes of quiet rest, with 1 minute of recovery between measures. SBP will be defined as the average of the 3 pressures.
Change from baseline to endpoint 1 (6 weeks) Nitric Oxide-mediated Endothelium Dependent Dilation (EDD)
时间窗: EDD will be assessed at baseline and after 6 weeks of training
Brachial artery Flow Mediated Dilation (BA-FMD), a well-established measure of NO-mediated endothelial function, will be measured by both relative and absolute changes from baseline. BA-FMD will be determined using high-resolution ultrasonography and analyzed with a commercially available software package. An ultrasound probe will be placed 3-6 cm proximal to the antecubital crease on the right arm and a baseline image of the right brachial artery will be obtained. Following baseline, reactive hyperemia will be produced by inflating a rapid-inflating blood pressure cuff. Brachial artery diameter change will be measured for 2 minutes following 5-min of forearm blood flow occlusion.
次要结局
- Change from baseline to endpoint 1 (6 weeks) cerebrovascular reactivity (CVR)(CVR will be assessed at baseline and after 6 weeks of training)
- Change from endpoint 1 (6 weeks) to endpoint 2 (+12 weeks)(CVR will be assessed after 6 weeks of training and after an additional 12 weeks of training)