Acute Cardiovascular Responses in Hypertensive Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Blood pressure outside the laboratory
研究概览
简要总结
The aim of this study was to evaluate the acute cardiovascular responses in hypertensive individuals, in waking and sleeping periods after application of different non-pharmacological therapies for the control of blood pressure (BP). Randomly and random volunteers held a session of each therapy: Acupuncture, aerobic exercise, essential oil inhalation, and session control with a minimum interval of 72 hours between them. On the day of sessions the volunteers did not use antihypertensive medication. The variables measured in the survey were the blood pressure and heart rate variability (HRV). Descriptive statistical averaging procedures, standard deviation and standard error of mean were adopted. Two-way ANOVA for repeated measures was performed post-hoc Tukey. The level of the study significance was set at p <0.05.
详细描述
This study deals with a controlled trial and randomized crossover, with intentional non-probabilistic sample. All participants were informed of the procedures adopted in the research, and then signed the Informed Consent and Informed (IC) according to the resolution 466/12 of the National Health Council (Annex 1). The initial recruitment of volunteers was held in October 2014 with the initial assessments being carried out in the same month, after the project is approved by the Ethics Committee and Ethics Studies and Research of the Federal University of São Francisco Valley under the registration number 0010 / 240914 CEDEP / UNIVASF, and data collection with volunteers was completed in July 2015.
The plant material of Eucalyptus globulus was collected in January and May 2015 in the city Petrolina, Pernambuco state, Brazil. The process of extraction of essential oil of eucalyptus, made by hydrodistillation method by Clevenger system. To set the number of survey participants was conducted sample calculation by G.Power 3.0 program where the F test was chosen - two-way ANOVA for repeated measures between groups and within the group. Whereas four (04) experimental sessions and eighteen (18) measures time for each session, as well as α = 0.05 and power = 0.80, the sample size of 12 subjects was required.
Participants were randomly recruited in health centers in the city of Petrolina / PE through disclosure / meeting to present the research project, in addition to the collaboration of health workers from surrounding neighborhoods to UNIVASF.
All participants were divided into blocks in accordance with CONSORT criteria. Initially, the research project, along with the IC, was presented to each of the candidates to volunteer, with discussion of the risks and benefits, both scientific and individual would be likely to compose the study sample. After agreeing on participation, and application of history about health history, readiness for exercise and risk stratification according to guidelines from the American College of Sports Medicine, the informed consent was signed, and then scheduled with the volunteer the day and time of the completion of resting ECG examination (held in a large hospital in Petrolina / PE and funded by the researchers), to check for possible abnormalities and ischemia suggestion above or below unevenness in the ST segment> 2 mm or inversion of the T wave. All ECG's 12-lead were performed and evaluated by a cardiologist, where no examination apesentou suggestion ischemia or abnormality that would prevent volunteer to carry out all stages of safely search. After meeting and selection of the sample in accordance with the guidelines on inclusion profile, participants were invited to attend the morning to CEFIS of UNIVASF to carry out the anthropometric measurements (height, weight, body mass index, waist circumference and body fat percentage), and schedule for the start of the experimental sessions.
Volunteers had the orientation to suspend the anti-hypertensive medication on the day of each session, and only return to use after the removal of equipment (next day) by the researcher. In addition to this recommendation, the volunteers should not eat on the day of the interventions, substances that contain caffeine, alcohol, chocolate, tea, passion fruit or any other stimulant or CNS retardant, but the eating routine should be followed. The practice of physical activity, including sexual, was banned in the days that applied sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •hypertensive mens;
- •clinically stable.
排除标准
- •Abnormalities in Resting ECG with cardiac ischemia suggestion;
- •Rank in Category 3 (known serious illness) the risk stratification of the American College of Sports Medicine;
- •Use of beta blocker medicine;
- •Heart or kidney failure;
- •Stroke history, coronary or peripheral arterial disease;
- •Decompensated diabetes with blood glucose greater than 300 mg.dL-1;
- •Autonomic dysfunction or severe peripheral;
- •Any amputation of limbs; Regular physical activity practice (> 150 minutes per week) in the last 06 months;
- •Uncontrolled hypertension with systolic blood pressure above 160 mmHg and diastolic blood pressure above 105 mmHg without medication;
- •Abnormality in the blood coagulation;
- •Allergy to the material of the acupuncture needle (stainless steel).
结局指标
主要结局
Blood pressure outside the laboratory
时间窗: 16 hours
次要结局
- Blood pressure in the laboratory(02 hours)
- Heart rate variability in the laboratory(02 hours)
- Heart rate variability outside the laboratory(16 hours)
研究者
Marcus Amando Fernandes da Silva
Master's Degree student
Universidade Federal do vale do São Francisco