Effects of Aerobic Interval and Continuous Exercise Trainings in Patients With Chronic Heart Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Chang Gung Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Science Council, Taiwan
Chang Gung University
Information provided by:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01229670
First received: October 18, 2010
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Cardiac and Hemodynamic Response
Blood Flow Distribution and Oxygen Uptake Efficiency
Hemorheology Modulated by Erythrocyte
Atherothrombosis Modulated by Monocyte
Angiogenesis Modulated by EPC
Other: exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Aerobic Interval and Continuous Exercise Trainings on Cardiovascular Hemorheological Characteristics and Atherothrombosis/Angiogenesis-related Variables in Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • ventilation efficacy [ Time Frame: three year ] [ Designated as safety issue: Yes ]
    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......


Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aerobic intermittent group
aerobic intermittent group
Other: exercise
  • 1.exercise(Aerobic interval training (AIT)): training with 90% of VO2 peak and 40% of VO2 peak cycle for total 30 minutes exercise time
  • 2.exercise(moderate continuous training (MCT)):training with 60% of VO2peak for 30 min
Experimental: aerobic continuous group
aerobic continuous group
Other: exercise
  • 1.exercise(Aerobic interval training (AIT)): training with 90% of VO2 peak and 40% of VO2 peak cycle for total 30 minutes exercise time
  • 2.exercise(moderate continuous training (MCT)):training with 60% of VO2peak for 30 min
No Intervention: control
home exercise group
Other: exercise
  • 1.exercise(Aerobic interval training (AIT)): training with 90% of VO2 peak and 40% of VO2 peak cycle for total 30 minutes exercise time
  • 2.exercise(moderate continuous training (MCT)):training with 60% of VO2peak for 30 min

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229670

Contacts
Contact: Jong-Shyan Wang, Ph.D 886-3-2118800 ext 5748 s5492@mail.cgu.edu.tw

Locations
Taiwan
Chang Gung University Recruiting
Kwei-Shan., Tao-Yuan, Taiwan, 333
Contact: Jong-Shyan Wang, Ph.D    886-3-218800 ext 5748    s5492@mail.cgu.edu.tw   
Principal Investigator: Jong-shyan Wang, Ph.D         
Sub-Investigator: Tieh-Cheng Fu, M.D         
Sponsors and Collaborators
Chang Gung Memorial Hospital
National Science Council, Taiwan
Chang Gung University
Investigators
Principal Investigator: Jong-Shyan Wang, Ph.D Chamg Gung university
  More Information

Publications:
Responsible Party: Jong-Shyan Wang, Chang Gung University
ClinicalTrials.gov Identifier: NCT01229670     History of Changes
Other Study ID Numbers: 98-3605B
Study First Received: October 18, 2010
Last Updated: October 27, 2010
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Heart failure
Hemorheology
Atherothrombosis
Angiogenesis

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 14, 2014