跳至主要内容
临床试验/NCT02050399
NCT02050399已完成不适用

Cardiovascular Oscillations at Rest and During Isometric Exercise in Coronary Patients With and Without Type 2 Diabetes

Universidade Federal de Sao Carlos1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Cardiovascular responses during isometric exercise

研究概览

简要总结

Coronary artery disease (CAD) and diabetes mellitus (DM) may promote alterations in heart responses during exercise or postural maneuver. Thus, the purpose of this study is to observe the influence of different postures (supine, seated and standing) and different percentages (15, 30, 45 and 60%) of the maximum voluntary contraction (MVC) of handgrip in the responses of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), cardiac output (CO), stroke volume (SV) and peripheral vascular resistance (PVR) in coronary patients with and without type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
是

入选标准

  • •coronary artery disease
  • •clinical diagnosis of type 2 diabetes
  • •free of type 2 diabetes to participate of control group and coronary disease without Type 2 Diabetes group
  • •nonsmokers
  • •not alcoholics

排除标准

  • •autonomic neuropathy
  • •clinical exercise testing with ECG alterations (ST-segment depression greater than 2 mm, ventricular and supraventricular arrhythmias, sustained or non-sustained supraventricular tachycardia, atrial tachycardia, atrial fibrillation and atrioventricular blocks) or symptom of angina induced by stress.
  • •Individuals with hypertension and diabetes mellitus not controlled.
  • •Subjects who did not complete all assessments.
  • •Subjects with temporal (R-Ri and pressure) series with noise preventing the evaluation

研究组 & 干预措施

Healthy subjects

Active Comparator

15 men, 45 and 65 years old. After initial evaluation, clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise protocol will be performed.

干预措施: Isometric exercise (Other)

Coronary disease with Type 2 Diabetes

Experimental

15 men, 45-65 years old, with coronary artery disease and type 2 diabetes will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood), clinical autonomic tests and isometric exercise protocol will be performed.

干预措施: Isometric exercise (Other)

Coronary disease without Type 2 Diabetes

Experimental

15 men, 45-65 years old, with coronary artery disease will perform clinical exercise testing, cardiopulmonary exercise testing, carotid ultrasound, laboratory tests (biochemical blood) and isometric exercise will be performed.

干预措施: Isometric exercise (Other)

结局指标

主要结局

Cardiovascular responses during isometric exercise

时间窗: Change in heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, cardiac output, stroke volume and peripheral resistance. [time frame: initial (10 min), during the time of contraction (peak) and after contraction (10 min)

15 men with coronary artery disease and 15 healthy subjects will perform isometric contractions (handgrip) in different percentages (15,30, 45 60%) of maximum voluntary contraction (MVC) and in different postures (supine, seated and standing position). The percentages and postures will be randomized and the subjects will perform two contractions per day in a posture. All the variables will be evaluated through pulse plethysmograph (Finometer PRO, Finapress Medical System, The Netherlands). The subjects will be assessed in the protocol of isometric exercise for six days (two contractions per day and one posture). Initially they will remain at rest for 10 minutes and wiil perform the percentage drawn of maximal voluntary contraction until exhaustion. After 10 minutes of recovery subjects will perform another percentage of maximum contraction to exhaustion.

次要结局

未报告次要终点

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aparecida Maria Catai

Cardiovascular oscillations at rest and during isometric exercise in coronary patients with and without type 2 diabetes

Universidade Federal de Sao Carlos

研究点 (1)

Loading locations...

相似试验