Effects of Two Types of Aerobic Training on Ambulatory Blood Pressure in Hypertensives: a Systems Biology Approach
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in 24-hour ambulatory blood pressure
研究概览
简要总结
This study will examine the effects of 4 months of aerobic interval training versus continuous aerobic training on ambulatory blood pressure (ABP) and novel plasma protein biomarkers in patients with resistant hypertension. A randomized controlled trial will be performed including two exercise groups and a control group: a) moderate-intensity interval training (MIIT); b) moderate-intensity continuous training (MICT); c) usual care. MIIT could represent a superior training modality that exceeds the benefits of MICT in patients with resistant hypertension.
详细描述
Hypertension is associated with an increased risk of cardiovascular morbidity and mortality, and its high prevalence remains a worldwide concern. Ambulatory blood pressure monitoring (ABPM) is recognized in the diagnosis and management of hypertension, and can control blood pressure better than clinic assessment. Different studies have examined the effects of aerobic training on ABP in patients with hypertension, but the effects of moderate-intensity interval training (MIIT) and moderate-intensity continuous training (MICT) on ABP and novel plasma protein biomarkers that could potentially serve to identify cardiovascular risk, have not yet been examined in patients with resistant hypertension.To fill this gap, our aims are to determine the effects of MIIT and MICT for 4 months on ABP (primary endpoint), and on proteomic biomarkers (secondary endpoints) in patients with resistant hypertension. A total of 72 participants will be randomly divided into three groups: the first group (n=24) will perform MIIT, the second group (n=24) will perform MICT, and the third control group (n=24) will maintain usual care for 4 months. All will receive usual care for 4 months, with the structured physical exercise as the only relevant change in the intervention groups.
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 (Care Provider, Outcomes Assessor)
盲法说明
Care providers and outcomes assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with resistant hypertension (RH) (i.e., systolic BP/diastolic BP >130/80 mmHg according to the American College of Cardiology/American Heart Association) despite the concurrent use of three or more antihypertensive drugs - commonly including a diuretic, a long-acting calcium channel blocker, and a blocker of the renin-angiotensin system. RH also includes patients whose BP achieves target values on ≥ 4 antihypertensive. medications (i.e., 'controlled' RH).
- •Adherence to prescribed medications.
- •Willing to be randomized to one of the 3 groups.
- •Informed consent.
排除标准
- •Exclusion criteria will include exercising more than 30 minutes on 3 days or more weekly.
- •Severe ischemic heart disease, major psychiatric disorder and other health contraindications that may interfere in the evaluations or interventions.
研究组 & 干预措施
Moderate-intensity continuous training (MICT)
24 participants with resistant hypertension will perform moderate-intensity continuous training.
干预措施: Moderate-intensity continuous training (MICT) (Other)
Moderate-intensity interval training (MIIT)
24 participants with resistant hypertension will perform moderate-intensity interval training.
干预措施: Moderate-intensity interval training (MIIT) (Other)
Usual care
24 participants with resistant hypertension will maintain usual care for 4 months.
结局指标
主要结局
Change in 24-hour ambulatory blood pressure
时间窗: Baseline to immediate post-treatment (4 months)
Ambulatory SBP and DBP will be recorded with a validated oscillometric device over 24 hours.
次要结局
- Changes in albuminuria(Baseline to immediate post-treatment (4 months))
- Changes in glomerular filtration rate(Baseline to immediate post-treatment (4 months))
- Change in plasma proteome(Baseline to immediate post-treatment (4 months))
- Changes in albuminuria(Baseline to immediate post-treatment (4 months))
- Changes in glomerular filtration rate(Baseline to immediate post-treatment (4 months))
研究者
Ruilope
Principal investigator
Universidad Europea de Madrid