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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring exercise-base rehabilitation, diastolic heart failure, cardiovascular function, aerobic fitness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

exercise

control

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
January 20, 2010
Last Updated
February 25, 2015
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01053091
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
exercise-base rehabilitation, diastolic heart failure, cardiovascular function, aerobic fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
exercise
Arm Title
Control
Arm Type
No Intervention
Arm Description
control
Intervention Type
Behavioral
Intervention Name(s)
exercise
Other Intervention Name(s)
behavioral
Intervention Description
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
Primary Outcome Measure Information:
Title
physical fitness including cardiovascular functions, oxygen transport and utilization of exercising skeletal muscles and hemodynamics
Time Frame
one year
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
T'sang-T'ang Hsieh, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
City
Keelung
ZIP/Postal Code
104
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
17428822
Citation
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.
Results Reference
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PubMed Identifier
17897465
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. doi: 10.1186/1476-7120-5-32.
Results Reference
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PubMed Identifier
19324966
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. No abstract available. Erratum In: Circulation. 2010 Mar 30;121(12):e258.
Results Reference
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PubMed Identifier
19351941
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, 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.
Results Reference
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PubMed Identifier
16286176
Citation
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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PubMed Identifier
26053189
Citation
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.
Results Reference
derived

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

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