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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053091
• Other study ID #: 98-1374B
• Status: Completed
• Phase: N/A
• First received: January 20, 2010
• Last updated: February 25, 2015
• Start date: October 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

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

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics		one year	No
Secondary	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	No