跳至主要内容
临床试验/NCT02855905
NCT02855905已完成不适用

Year-round Health Enhancing Exercise and Coronary Artery Disease: Randomized Controlled Study

University of Oulu2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Blood pressure [mmHg, millimeter of mercury]

研究概览

简要总结

A cold season involves higher cardiovascular morbidity and mortality. Several epidemiologic studies have implicated that persons with a cardiac disease, such as coronary artery disease (CAD) may be at higher risk for these adverse health events, but the mechanisms are not well established. Because both exercise and cold exposure stimulates cardiac and circulatory functions it is important to study their interaction especially among people with CAD and whose myocardial oxygen supply and function are weakened. The study examines how recommended health-enhancing upper and lower body exercise and warm-up in combination with cold exposure affects cardiovascular functions of people with CAD.

The research includes randomized controlled experiments where the participants are 35-75 year old men with CAD (CCS I-II) and recruited from the Oulu University Hospital. Each participant undergoes four different trials in random order where the temperature (+22°C or -15°C) and the form of exercise (brisk walking at 5.5 km/h or upper body exercise at 30 W), and warm-up regime is varied. The used exercise, clothing and exposure resemble an ordinary wintertime exercise event. Novel techniques are used to broadly assess cardiovascular function before, during and in the recovery phase.

The obtained information is synthesized and translated to tailored year-round exercise instructions for people with CAD by the research team including experts from sports sciences, physiology, public and occupational health, clinical sciences and with complementary knowledge in physical activity, effective interventions and cardiovascular function. The study has broad national and international impact on the relatively passive aging population having CAD and residing and working in a cold climate. The produced information enables finding means to activate persons with CAD and where appropriate and safe year-round exercise may reduce or prevent adverse health effects. Health care personnel will have an improved possibility to prescribe physical activity programs for their clients and enabling better instructions of healthy and safe exercise as a way to promote health.

详细描述

Introduction

National and International significance of the research

According to a worldwide estimate 42% of people with coronary artery disease (CAD) are physically inactive. There are approximately 200 000 persons in Finland with CAD, and even more have other connected health problems (high cholesterol or blood pressure, diabetes) further weakening their cardiac function and physical capacity and causing mortality. This increasing ageing population are often inactive, but would benefit substantially from regular year-round physical activity for maintaining their functional ability and independent living.

At present it is not known whether the exercise recommendation for CAD patients involves a health risk during cold exposure as they regularly report symptoms of chest pain and arrhythmias in the winter. Because both exercise and cold exposure stimulates cardiac and circulatory functions precise physical activity require defining their interaction among CAD patients whose myocardial oxygen supply and function are weakened.

Nationally and internationally the research addresses a large and special population group living in the northern hemisphere, whose symptoms, health events and mortality are common and provoked in the cold season. A passive lifestyle of this population is partially due to inadequate instructions and guidance. As a result of ageing the proportion of people with CAD will increase which emphasizes the role of prevention in reducing health care costs. The proposed research entity forms an important part of the research program examining the direct effect of temperature on human health in the newly established WHO Collaboration Centre in Global change, Environment and Public Health.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • CCS class I-II
  • Non-smokers
  • Hypertension
  • Myocardial infarction over 3 months ago

排除标准

  • NYHA CCS class III-IV
  • Myocardial infarction less than 3 months ago
  • Chronic atrial fibrillation
  • Claudication
  • Unstable angina pectoris
  • Serious complex arrhythmias or ECG anomalies during rest.
  • Bypass surgery
  • Angioplasty

研究组 & 干预措施

Coronary artery disease patients

Experimental

Coronary artery disease patients are exposed to brief cold exposure (-15 C for 30 min) mainly subjected to facial region during which their cardiovascular responses are registered. Exposure was repeated 4 times: rest and exercise in 22 C and rest and exercise in -15 C.

干预措施: Exercise/Rest and cold/neutral temperature (Other)

结局指标

主要结局

Blood pressure [mmHg, millimeter of mercury]

时间窗: 3 hours

Brachial blood pressure

次要结局

  • Stress hormones (catecholamines) [nmol/l, nanomol / liter](3 hours)
  • blood coagulation factors [mg/l, milligram / liter](3 hours)
  • Skin temperature [°C, celsius](3 hours)
  • inflammatory markers [ng/l, nanogram / liter](3 hours)
  • Central aortic blood pressure [mmHg, millimeter of mercury](3 hours)
  • Electrocardiogram [mV, milliVolts](3 hours)
  • Flow-mediated dilation [arterial diameter mm, millimeter](3 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验