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

NCT01053091 | Completed DMC

• 1 other identifier: 98-1374B
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics

  one year

Secondary Outcomes (1)

• 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

Study Arms (2)

Exercise

EXPERIMENTAL

exercise

Behavioral: exercise

Control

NO INTERVENTION

control

Interventions

exercise BEHAVIORAL

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

Also known as: behavioral

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• unstable angina pectoris,
• uncompensated heart failure,
• myocardial infarction during the past 4 weeks,
• complex ventricular arrhythmias,
• orthopedic or neurological limitations to exercise.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital

Keelung, 104, Taiwan

Location

Related Publications (7)

• Paulus WJ, Tschope C, Sanderson JE, Rusconi C, Flachskampf FA, Rademakers FE, Marino P, Smiseth OA, De Keulenaer G, Leite-Moreira AF, Borbely 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. doi: 10.1093/eurheartj/ehm037. Epub 2007 Apr 11.

  PMID: 17428822 BACKGROUND

• 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. doi: 10.1186/1476-7120-5-32.

  PMID: 17897465 BACKGROUND

• 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. No abstract available.

  PMID: 19324966 BACKGROUND

• 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, Pina 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.

  PMID: 19351941 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.07.051. Epub 2005 Oct 24.

  PMID: 16286176 BACKGROUND

• 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.

  PMID: 19281919 BACKGROUND

• 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.

  PMID: 26053189 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Failure, Diastolic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• T'sang-T'ang Hsieh, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: January 20, 2010
• First Posted: January 21, 2010
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: February 26, 2015

Record last verified: 2015-02

Locations

TW (1)