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

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

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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% Exclusion Criteria: unstable angina pectoris, uncompensated heart failure, myocardial infarction during the past 4 weeks, complex ventricular arrhythmias, orthopedic or neurological limitations to exercise.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>exercise | Behavioral: exercise<br>* 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<br>* Other names: behavioral;|
| No Intervention: Control<br>control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise-base rehabilitation, diastolic heart failure, cardiovascular function, aerobic fitness