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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fu Tieh Cheng, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01053091
First received: January 20, 2010
Last updated: February 25, 2015
Last verified: February 2015
History of Changes
  Purpose

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


Condition Intervention
Heart Failure
 Behavioral: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood cell parameters, RBC deformity and aggregation, plasma biomarkers of myocardial damage, and thrombotic factors/reactions change between pre-ex and post-ex. [ Time Frame: one year ] [ Designated as safety issue: No ]
Enrollment: 120
Study Start Date: October 2009
Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
exercise
 Behavioral: exercise
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
Other Name: behavioral
No Intervention: Control
control

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053091

Locations
Taiwan
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
Keelung, Taiwan, 104
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: T'sang-T'ang Hsieh, MD Chang Gung Memorial Hospital
  More Information

Publications:

Responsible Party: Fu Tieh Cheng, attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01053091     History of Changes
Other Study ID Numbers: 98-1374B
Study First Received: January 20, 2010
Last Updated: February 25, 2015
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
exercise-base rehabilitation
diastolic heart failure
cardiovascular function
aerobic fitness

Additional relevant MeSH terms:
Heart Failure
Heart Failure, Diastolic
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on February 27, 2015