- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229670
Effects of Aerobic Interval and Continuous Exercise Trainings in Patients With Chronic Heart Failure
Effects of Aerobic Interval and Continuous Exercise Trainings on Cardiovascular Hemorheological Characteristics and Atherothrombosis/Angiogenesis-related Variables in Patients With Chronic Heart Failure
Heart failure (HF) is a major and increasingly common cardiovascular syndrome, and is the end result of many cardiovascular disorders. It has been reported that HF patients with pharmacological therapy often remain burdened by dyspnea and fatigue, diminished exercise tolerance, reduced quality of life, recurrent hospitalizations, and early mortality. HF is associated with neurohumoral changes as the body attempts to reverse the effect of reduced cardiac output and organ perfusion. Persistent neurohumoral excitation, however, actually results in deterioration of myocardial function with inflammatory response, end-organ damage, and skeletal muscle derangement, which lead to worsened exercise capacity.
Physical training can have beneficial effects on neurohumoral, inflammatory, metabolic and central hemodynamic responses, as well as on endothelial, skeletal muscle and cardiovascular function, leading to improvement in functional capacity and quality of life. All these training-induced changes can effectively counteract the progression of deleterious compensatory mechanisms of HF.
Several lines of evidence suggest greater aerobic and cardiovascular adaptations after high-intensity exercise than with moderate levels in patients with coronary artery disease or left ventricular dysfunction function and in healthy subjects. Aerobic interval training (AIT) involving periods at 90% of VO2peak has been shown to rescue impaired cardiomyocyte contractility, attenuate myocardial hypertrophy, and reduce myocardial expression of atrial natriuretic peptide in animal model of post-infarction heart failure. However, underlying mechanisms of AIT-improved regulations remain unclear.
The different effects of AIT and moderate continuous training (MCT) on hemorheology, atherothrombosis or angiogenesis modulated by erythrocyte, monocyte or EPC in patients with CHF have been not investigated yet. Accordingly, the investigators will conduct this three-year study to clarify how the two exercise trainings affect cardiovascular hemorheological characteristics and atherothrombosis/ angiogenesis-related variables in patients with chronic heart failure. The investigators expect that these results obtained from this study can aid in determining appropriate exercise intervention to improve aerobic fitness as well as simultaneously improve hemodynamic control and minimize the risk of thrombogenesis in patients with CHF.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Heart failure (HF) is a major and increasingly common cardiovascular syndrome, and is the end result of many cardiovascular disorders. It has been reported that HF patients with pharmacological therapy often remain burdened by dyspnea and fatigue, diminished exercise tolerance, reduced quality of life, recurrent hospitalizations, and early mortality. HF is associated with neurohumoral changes as the body attempts to reverse the effect of reduced cardiac output and organ perfusion. Persistent neurohumoral excitation, however, actually results in deterioration of myocardial function with inflammatory response, end-organ damage, and skeletal muscle derangement, which lead to worsened exercise capacity.
Physical training can have beneficial effects on neurohumoral, inflammatory, metabolic and central hemodynamic responses, as well as on endothelial, skeletal muscle and cardiovascular function, leading to improvement in functional capacity and quality of life. All these training-induced changes can effectively counteract the progression of deleterious compensatory mechanisms of HF. Which exercise intensity yields maximal beneficial adaptations is controversial.
Several lines of evidence suggest greater aerobic and cardiovascular adaptations after high-intensity exercise than with low and moderate levels in patients with coronary artery disease or left ventricular dysfunction function and in healthy subjects. Aerobic interval training (AIT) involving periods at 90% of VO2peak has been shown to rescue impaired cardiomyocyte contractility, attenuate myocardial hypertrophy, and reduce myocardial expression of atrial natriuretic peptide in animal model of post-infarction heart failure.
However, underlying mechanisms of AIT-improved regulations of cardiac hemodynamics and risk factors in patients with CHF remain unclear.
Pathological erythrocyte deformability and aggregation reduces capillary perfusion and oxygen transfer to tissue, resulting in tissue ischemia or infraction. Shedding of procoagulant-rich microparticles from activated monocytes can accelerate the pathogenesis of atherothrombosis. Bone marrow-derived, circulating endothelial progenitor cells (EPC) is contributes to the maintenance of endothelial function and organ perfusion by mechanisms ranging from endothelial repair to angiogenesis. However, the different effects of AIT and moderate continuous training (MCT) on hemorheology, atherothrombosis or angiogenesis modulated by erythrocyte, monocyte or EPC in patients with CHF have been not investigated yet.
Accordingly, we will conduct this three-year study that includes 1st year study: the effects of AIT and MCT on hemorheology modulated by erythrocyte in patients with CHF; 2nd year: the effects of AIT and MCT on atherothrombosis modulated by monocyte in patients with CHF; and 3rd year study: the effects of AIT and MCT on angiogenesis modulated by EPC in patients with CHF to clarify how the two exercise trainings affect cardiovascular hemorheological characteristics and atherothrombosis/ angiogenesis-related variables in patients with chronic heart failure. We expect that these results obtained from this study can aid in determining appropriate exercise intervention to improve aerobic fitness as well as simultaneously improve hemodynamic control and minimize the risk of thrombogenesis in patients with CHF.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jong-Shyan Wang, Ph.D
- Phone Number: 5748 886-3-2118800
- Email: s5492@mail.cgu.edu.tw
Study Locations
-
-
Tao-Yuan
-
Kwei-Shan., Tao-Yuan, Taiwan, 333
- Recruiting
- Chang Gung University
-
Contact:
- Jong-Shyan Wang, Ph.D
- Phone Number: 5748 886-3-218800
- Email: s5492@mail.cgu.edu.tw
-
Principal Investigator:
- Jong-shyan Wang, Ph.D
-
Sub-Investigator:
- Tieh-Cheng Fu, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aerobic intermittent group
|
|
Experimental: aerobic continuous group
|
|
No Intervention: control
home exercise group
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ventilation efficacy
Time Frame: three year
|
Ventilation efficacy could be show as ventilation equivalent(minute ventilation / oxygen consumption (VE/VO2) or minute ventilation / Carbon dioxide production (VE/VCO2).
The slope of VE/VCO2 predict mortality in HF patient.
These data ia available during cardiopulmonary exercise test(CPX or CPET).
We also got other traditional data including Peak HR, Peak O2 consumption, Peak workload......
|
three year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jong-Shyan Wang, Ph.D, Chamg Gung university
Publications and helpful links
General Publications
- Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
- Rognmo O, Hetland E, Helgerud J, Hoff J, Slordahl SA. High intensity aerobic interval exercise is superior to moderate intensity exercise for increasing aerobic capacity in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil. 2004 Jun;11(3):216-22. doi: 10.1097/01.hjr.0000131677.96762.0c.
- Engoren M, Barbee D. Comparison of cardiac output determined by bioimpedance, thermodilution, and the Fick method. Am J Crit Care. 2005 Jan;14(1):40-5.
- Ribeiro JP, Stein R, Chiappa GR. Beyond peak oxygen uptake: new prognostic markers from gas exchange exercise tests in chronic heart failure. J Cardiopulm Rehabil. 2006 Mar-Apr;26(2):63-71. doi: 10.1097/00008483-200603000-00001. No abstract available.
- Belardinelli R, Barstow TJ, Porszasz J, Wasserman K. Changes in skeletal muscle oxygenation during incremental exercise measured with near infrared spectroscopy. Eur J Appl Physiol Occup Physiol. 1995;70(6):487-92. doi: 10.1007/BF00634377.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 98-3605B
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