Clinical trial NCT01053091: Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure
Official title: Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: exercise-base rehabilitation
diastolic heart failure
cardiovascular function
aerobic fitness
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2010-01-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics
timeFrame: one year
Secondary outcomes:
measure: blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions change between pre-ex and post-ex.
timeFrame: one year
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: T'sang-T'ang Hsieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
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