NCT01229670

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 28, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 28, 2010

Status Verified

October 1, 2010

Enrollment Period

2.9 years

First QC Date

October 18, 2010

Last Update Submit

October 27, 2010

Conditions

Keywords

Heart failureHemorheologyAtherothrombosisAngiogenesis

Outcome Measures

Primary Outcomes (1)

  • ventilation efficacy

    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

Study Arms (3)

aerobic intermittent group

EXPERIMENTAL

aerobic intermittent group

Other: exercise

aerobic continuous group

EXPERIMENTAL

aerobic continuous group

Other: exercise

control

NO INTERVENTION

home exercise group

Other: exercise

Interventions

* 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

aerobic continuous groupaerobic intermittent groupcontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Kwei-Shan., Tao-Yuan, 333, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 15179103BACKGROUND
  • 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.

    PMID: 16569970BACKGROUND
  • 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.

    PMID: 15608107BACKGROUND
  • 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.

    PMID: 7556120BACKGROUND
  • 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.

    PMID: 17548726BACKGROUND

MeSH Terms

Conditions

Heart FailureThrombosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesEmbolism and ThrombosisVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jong-Shyan Wang, Ph.D

    Chamg Gung university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong-Shyan Wang, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 28, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 28, 2010

Record last verified: 2010-10

Locations