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临床试验/NCT02270216
NCT02270216Unknown不适用

Study of Cardiovascular Responses to Static and Dynamic Exercise in Isolated Systolic Hypertension

Sahachat Aueyingsak2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
heart rate

研究概览

简要总结

Aim to study the exercise responses to both static and dynamic exercise in elderly people with and without essential isolated systolic hypertension, seeking to identify potentially dangerously high responses

详细描述

  1. Design The proposed study is of a experimental study design. The study will be subject to approval by the Ethical committee of Khon Kaen University and subjects will be asked to give their written agreement to participate.
  2. Subjects Elderly subjects with isolated systolic hypertension will be recruited from primary care units in the community and outpatient department of Srinakarind hospital in Khon Kaen province. Healthy normotensive subjects living independently with normal physical activity will be recruited from the same community.

Inclusion criteria: Subjects should be over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group and normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, non-obese, free of any signs or symptoms of disease as revealed by medical history Exclusion criteria: Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain Subjects who have passed the inclusion criteria and exclusion criteria will undertake a dynamic exercise test and a static hand-grip exercise pressor test in the cardiopulmonary research room , Khon Kaen University 3. Outcome measurements The main outcome measures will be changes in blood pressure and heart rate during the two forms of exercise.

Blood pressure: Blood pressure will be measured with a digital bedside monitor (Figure 1). An inflatable cuff placed around the subject's arm one inch above the patient's elbow over the brachial artery. Resting blood pressure will be measured in a sitting position after having rested for 15 minutes Heart rate: Heart rate will be measured at rest and during exercise. ECG electrode will be attached in lead II configuration and connected to the BIOPAC system. The heart rate will be determined from the R-R interval with the data analyzed by the BIOPAC system. 4. Procedures and protocol After an interview where they will be informed about the various tests and asked to provide their informed consent, the subjects will undertake two different exercise tests, the order of which will be in a randomized and balanced design. The subjects will be asked not to smoke, take alcohol or caffeinated drinks within 2 hours before testing.

Cycling exercise: The dynamic exercise will be with the subject sitting on a cycle ergometer (Monark 828 E). Resting heart rate will be measured for 2 minutes before the start of exercise. The exercise level will be limited to 50% of the estimated maximum heart rate reserve. Maximum heart rate will be estimated as 207-0.7*age (Gellish et al., 2007) and heart rate reserve (HRR) as maximum minus resting heart rate. Subjects will pedal at 50 rpm for 1 min with no load and then 3 minutes against a load of 0.5 Kp (25W) increasing to a load of 1 Kp for the next 3 minutes and to 1.5 Kp, if necessary, for a further 3 minutes until the target heart rate of 50% HRR is reached.

Subjects will be asked about their level of perception of dyspnea using a visual analog scale every 3 minutes at the end of each load.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects should be over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group and normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, non-obese, free of any signs or symptoms of disease as revealed by medical history

排除标准

  • Essential hypertension stage III or secondary hypertension, any history of respiratory disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise limited by pain

研究组 & 干预措施

elderly with isolated systolic hypertension

Active Comparator

over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history

干预措施: cycling exercise (Procedure)

elderly with isolated systolic hypertension

Active Comparator

over 60 years of age with essential isolated systolic hypertension (stage I-II base on recommendation of JNC-VII) for the hypertension group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history

干预措施: static hand grip exercise (Procedure)

healthy elderly

Active Comparator

over 60 years of age with normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history

干预措施: static hand grip exercise (Procedure)

healthy elderly

Active Comparator

over 60 years of age with normal blood pressure in the healthy group. Good communication, independent physical activity. The healthy subject should be non-smokers, free of any signs or symptoms of disease as revealed by medical history

干预措施: cycling exercise (Procedure)

结局指标

主要结局

heart rate

时间窗: 6 month

Heart rate will be measured at rest and during exercise. ECG electrode will be attached in lead II configuration and connected to the BIOPAC system. The heart rate will be determined from the R-R interval with the data analyzed by the BIOPAC system.

Blood pressure

时间窗: 6 month

Blood pressure will be measured with a digital bedside monitor. An inflatable cuff placed around the subject's arm one inch above the patient's elbow over the brachial artery. Resting blood pressure will be measured in a sitting position after having rested for 15 minutes

次要结局

未报告次要终点

研究者

发起方
Sahachat Aueyingsak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sahachat Aueyingsak

Master's Degree Student

Khon Kaen University

研究点 (2)

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