跳至主要内容
临床试验/NCT01053091
NCT01053091已完成不适用

Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年10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
120
试验地点
1
主要终点
physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics

研究概览

简要总结

The purpose of this study is to investigate how exercise-base rehabilitation influences circulatory functions in patients with diastolic heart failure (DHF).

详细描述

A quasi-experimental design will be used in this investigation. Eighty DHF patients will be recruited from Chang Gung Medical Foundation, Keelung Branch after they have provided informed consent. These subjects will be randomized into the trained (n=40) and the control groups (n=40). The trained subjects will be trained on a bicycle ergometer at about 60-70%of heart rate reserve for 35-55 minutes (that will include 10-min warm-up, 15-35-min main exercise, and 10-min cool-down) per day, 3 days per week for 12 weeks. The control subjects will maintain their normal living pattern. Subjects' physical fitness, oxygen transport and utilization of exercising skeletal muscles, cardiovascular functions and hemodynamics, blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions will be measured at pre-training stage and following the 8th and 12th week of the training program. Experimental results were analyzed by descriptive statistics (percentage, mean, and standard deviation), independent t-test, two-way ANOVA, and two-way ANCOVA. Previous researches were mainly focus on systolic heart failure, less on diastolic heart failure. We study the above parameter to realize the physiological response to exercise of these patients and discover the appropriate exercise intensity for prescription.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •cardiac event with optimal medial treatment within 3 months and have 4 more weeks spared from heart disease attack or major cardiac procedure.
  • •LVEF>50%

排除标准

  • •unstable angina pectoris,
  • •uncompensated heart failure,
  • •myocardial infarction during the past 4 weeks,
  • •complex ventricular arrhythmias,
  • •orthopedic or neurological limitations to exercise.

研究组 & 干预措施

Exercise

Experimental

exercise

干预措施: exercise (Behavioral)

Control

No Intervention

control

结局指标

主要结局

physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics

时间窗: one year

次要结局

  • blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions change between pre-ex and post-ex.(one year)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fu Tieh Cheng

attending physician

Chang Gung Memorial Hospital

研究点 (1)

Loading locations...

相似试验

Effect of Exercise-based Rehabilitation on... | 临床试验