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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Heart Failure	Behavioral: exercise	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Exercise-based Rehabilitation on Circulatory Functions in Patients With Diastolic Heart Failure
Study Start Date :	October 2009
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics [ Time Frame: one year ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Paulus WJ, Tschöpe C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbély A, Edes I, Handoko ML, Heymans S, Pezzali N, Pieske B, Dickstein K, Fraser AG, Brutsaert DL. How to diagnose diastolic heart failure: a consensus statement on the diagnosis of heart failure with normal left ventricular ejection fraction by the Heart Failure and Echocardiography Associations of the European Society of Cardiology. Eur Heart J. 2007 Oct;28(20):2539-50. Epub 2007 Apr 11.

Loimaala A, Groundstroem K, Rinne M, Nenonen A, Huhtala H, Vuori I. Exercise training does not improve myocardial diastolic tissue velocities in Type 2 diabetes. Cardiovasc Ultrasound. 2007 Sep 26;5:32.

Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW. 2009 focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the International Society for Heart and Lung Transplantation. Circulation. 2009 Apr 14;119(14):e391-479. doi: 10.1161/CIRCULATIONAHA.109.192065. Epub 2009 Mar 26. Review. Erratum in: Circulation. 2010 Mar 30;121(12):e258.

O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.

Guazzi M, Myers J, Arena R. Cardiopulmonary exercise testing in the clinical and prognostic assessment of diastolic heart failure. J Am Coll Cardiol. 2005 Nov 15;46(10):1883-90. Epub 2005 Oct 24.

Maeder MT, Kaye DM. Heart failure with normal left ventricular ejection fraction. J Am Coll Cardiol. 2009 Mar 17;53(11):905-18. doi: 10.1016/j.jacc.2008.12.007. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fu TC, Yang NI, Wang CH, Cherng WJ, Chou SL, Pan TL, Wang JS. Aerobic Interval Training Elicits Different Hemodynamic Adaptations Between Heart Failure Patients with Preserved and Reduced Ejection Fraction. Am J Phys Med Rehabil. 2016 Jan;95(1):15-27. doi: 10.1097/PHM.0000000000000312.

Responsible Party:	Fu Tieh Cheng, attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01053091 History of Changes
Other Study ID Numbers:	98-1374B
First Posted:	January 21, 2010
Last Update Posted:	February 26, 2015
Last Verified:	February 2015

Keywords provided by Fu Tieh Cheng, Chang Gung Memorial Hospital:

exercise-base rehabilitation; diastolic heart failure; cardiovascular function; aerobic fitness

Additional relevant MeSH terms:

Heart Failure; Heart Failure, Diastolic; Heart Diseases; Cardiovascular Diseases