Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients with Hypertension. a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
研究概览
简要总结
This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.
详细描述
Arterial hypertension is a global health burden that affects the structure and function of large and small blood vessels and induces disease-specific end-organ damage. Exercise therapy is highly recommended in the treatment of arterial hypertension to reduce blood pressure and ameliorate hypertension-induced vascular damage. Previous exercise intervention studies have shown that exercise treatment improves vascular dysfunction independently of changes in blood pressure. Several sensitive vascular biomarkers exist that could optimize risk stratification and therapeutic decisions based on the progression of individual vascular damage in patients with arterial hypertension. However, individualized vascular assessment during anti-hypertensive treatment is not yet part of routine clinical practice. In order to improve clinical decision making from a personalized medicine perspective, it is essential to better understand which vascular biomarkers have the best sensitivity in detecting therapy-induced vascular adaptations and whether anti-hypertensive therapy with or without additional exercise improves vascular health in patients with hypertension. The proposed study will evaluate the effects of guideline-directed anti-hypertensive therapy with or without individualized exercise training intervention in 60 patients with hypertension and no previous medical treatment for one year. Regular outpatient assessments of blood pressure and large and small blood vessels will be performed every two months. Anti-hypertensive therapy will be based on the current guidelines of the European Society of Hypertension. The investigators aim to achieve the target blood pressure after six months of treatment. A further six-month follow-up is planned to assess the long-term effects of anti-hypertensive therapy, with or without additional individualized exercise training intervention, on blood pressure and macro- and microvascular health. In addition, the investigators will investigate the effect of metabolic changes induced by anti-hypertensive treatment or individualized exercise training intervention on vascular health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systolic hypertension grade I-II (BP values >140 mmHg to <180 mmHg) without anti-hypertensive medication treatment
排除标准
- •no written informed consent
- •age <18 years
- •isolated diastolic hypertension
- •medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test)
- •chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (>20 mmHg)
研究组 & 干预措施
Individualized exercise training group
Beside a guideline based anti-hypertensive therapy, patients in the intervention group will receive an individualized exercise training program 3x/week. Exercise training will be a combination of aerobic and resistance training and is based on each patient's individual fitness level. Regular contact between exercise physiologists and patients, as well as group sessions, will help patients to maintain a regular exercise program.
干预措施: Individualized exercise therapy (Behavioral)
Individualized exercise training group
Beside a guideline based anti-hypertensive therapy, patients in the intervention group will receive an individualized exercise training program 3x/week. Exercise training will be a combination of aerobic and resistance training and is based on each patient's individual fitness level. Regular contact between exercise physiologists and patients, as well as group sessions, will help patients to maintain a regular exercise program.
干预措施: Lifestyle recommendations (Behavioral)
Control group
Beside a guideline based anti-hypertensive therapy, patients in the lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.
干预措施: Lifestyle recommendations (Behavioral)
结局指标
主要结局
The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.
时间窗: From enrollment to the end of treatment after six month.
The retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).
Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters.
时间窗: From enrollment to the end of treatment after six month.
Changes of retinal vessel diameters will be analyzed based on the arteriolar-to-venular diameter ratio (AVR).
次要结局
- Effect of an guideline based anti-hypertensive therapy on the systolic and diastolic blood pressure.(From enrollment to the end of treatment after six month.)
- Effect of a guideline based anti-hypertensive therapy on the NO metabolism of stored blood samples.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the systolic and diastolic blood pressure compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the microvascular endothelial function compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- Effect of an guideline based anti-hypertensive therapy on the microvascular endothelial function.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the arterial stiffness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the metabolic profile of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- Effect of an guideline based anti-hypertensive therapy on arterial stiffness.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on physical fitness compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- Effect of an guideline based anti-hypertensive therapy on physical fitness.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the NO metabolism of stored blood samples compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- Effect of a guideline based anti-hypertensive therapy on the metabolic profile of stored blood samples.(From enrollment to the end of treatment after six month.)
- The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on systemic inflammation markers compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations.(From enrollment to the end of treatment after six month.)
- Effect of a guideline based anti-hypertensive therapy on systemic inflammation markers of stored blood samples.(From enrollment to the end of treatment after six month.)