Effect of Heated Water-Based Versus Land-Based Exercise Training on Hemodynamic Variables, Functional Capacity and Quality of Life in Older
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
- Blood pressure change
研究概览
简要总结
BACKGROUND: Physical exercise promotion is one of the main global goals of innumerous health and medical societies for preventing and managing noncommunicable chronic diseases (NCDs), being one of the main therapeutic for the patient with hypertension. Exercise in heated swimming pool has emerged as a potential alternative to physical exercise on the ground for the reduction of blood pressure (BP) of hypertensive patients, however, its effects on BP, as well as hemodynamic, metabolic, inflammatory and functional variables of older individuals with hypertension have not been investigated.
PURPOSE: To evaluate the effects of heated water-based exercise (HEx) versus land-based exercise (LEx) on BP, arterial stiffness, endothelial function, metabolic, inflammatory and functional variables of older individuals with hypertension.
METHODS: 60 older individuals (male and female) with hypertension (age > 60 years) will be randomized in 2:2:1 ratio to HEx, LEx or control (CON) intervention. The feasibility and physiological adaptations (physical capacity, musculoskeletal and cardiovascular responses to stress, biological and biochemical markers associated with the pathophysiology of the disease and vascular adaptations) will be assessed before, after 12 weeks and after 24 weeks of follow-up. HEx and LEx training programs will be performed three times per week and will be performed for the firs 12 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For the study population, the following will not be included in the study:
- •Smokers (avoiding acute effects of smoking on physiological measures);
- •Individuals with decompensated cardiovascular disease, thyroid dysfunction and / or inflammatory diseases;
- •Unable individuals to perform an exercise program or ergospirometric test due to physical or mental incapacity;
- •Individuals with hemodynamic and / or electrocardiographic changes during the ergospirometric test.
- •Only individuals older than 60 years, with a diagnosis of SAH for more than 6 months (stage 1 or 2), using antihypertensive medication (office BP less than 140/90 mmHg) and without medication change for at least 2 months.
排除标准
- •For the study population, individuals who have less than 60% adherence to scheduled physical exercise sessions will be excluded during the study.
- •Individuals who change or discontinue their clinical and / or pharmacological treatment (with or without a prescription).
研究组 & 干预措施
HAS HEX vs HAS LEX
干预措施: Physical Exercise Session in Land- LEx (Other)
HAS HEX vs HAS LEX
干预措施: Physical Exercise Session in heated Swimming Pool - HEx (Other)
HAS HEX vs HAS CON
干预措施: Physical Exercise Session in heated Swimming Pool - HEx (Other)
HAS HEX vs HAS CON
干预措施: Control Session Without Exercise- CON (Other)
HAS LEX vs HAS CON
干预措施: Physical Exercise Session in heated Swimming Pool - HEx (Other)
HAS LEX vs HAS CON
干预措施: Control Session Without Exercise- CON (Other)
结局指标
主要结局
Blood pressure change
时间窗: baseline, 3 month and 6 month
24-hour systolic and diastolic ambulatory blood pressure change from baseline
次要结局
- Arterial stiffness(baseline, 3 month and 6 month)
- Brachial artery flow-mediated dilation (FMD)(baseline, 3 month and 6 month)
- First ventilatory threshold (anaerobic threshold)(baseline, 3 month and 6 month)
- Maximal oxygen consumption(baseline, 3 month and 6 month)
- Change from baseline in the second ventilatory threshold (respiratory compensation point)(baseline, 3 month and 6 month)
- Handgrip strength(baseline, 3 month and 6 month)
- Flexibility(baseline, 3 month and 6 month)
- Lower-limb strength(baseline, 3 month and 6 month)
- Agility and balance(baseline, 3 month and 6 month)
- Exercise tolerance(baseline, 3 month and 6 month)
- Endurance performance(baseline, 3 month and 6 month)
研究者
Emmanuel Gomes Ciolac
Associate Professor
Universidade Estadual Paulista Júlio de Mesquita Filho