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Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168712
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
KOLDO VILLELABEITIA JAUREGUIZAR, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief Summary:

Exercise therapy increase functional capacity improving the morbidity and mortality of patients with cardiovascular disease. Moderate continuous training is the best established training modality for this patients. However, a body of evidence has begun to emerge demonstrating that high intensity interval training obtained better results in terms of morbidity and mortality.

The purpose of this randomized clinical trial was to determine the effect of two types of exercise training: moderate continuous training vs high interval training on functional capacity and quality of life as well as verify the safety in its application.

We included 72 patients with coronary artery disease by assigning one of the training modality for 8 weeks. We analyzed cyclo-ergo-spirometry data, aspect related to quality of life as well as a record of adverse events.


Condition or disease Intervention/treatment Phase
Coronary Heart Disease Other: Moderate continuous exercise training Other: Interval exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial
Study Start Date : November 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Moderate continuous exercise training
Moderate intensity continuous exercise training
Other: Moderate continuous exercise training
Experimental: Interval exercise training
High intensity interval exercise training
Other: Interval exercise training



Primary Outcome Measures :
  1. Impact on functional capacity [ Time Frame: 2 months ]
    Basal and peak oxygen consumption values will be measured.


Secondary Outcome Measures :
  1. quality of life [ Time Frame: 2 months ]
    Quality of life will be compared between the two arms with one generic questionnaire (SF-36) and one ischemic heart disease specific questionnaire (MacNew)


Other Outcome Measures:
  1. Incidence of Adverse Events [ Time Frame: 2 months ]
    The incidence of cardiovascular adverse events in each group will be compared



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary heart Disease, with functional class II-III according to New York Heart Association classification system.
  • At least 4 weeks from acute cardiac event, percutaneous or surgery revascularization.
  • Optimized medical treatment in adequate doses ( betablockers, ACE inhibitors, ARA II, statins and antiplatelet drugs)
  • Age > 18 years old.
  • Willing to participate and sign an informed consent form

Exclusion Criteria:

  • Residual ischemia waiting for revascularization.
  • Any cardiac event for the last 4 weeks
  • Abnormal Ergometry with hemodynamic or clinically significant arrhythmias during the procedure.
  • History of severe ventricular arrhythmia
  • Uncontrolled glycaemia or blood pressure
  • Moderate to severe Chronic Pulmonary Obstructive Disease
  • Osteomuscular and/or mental disorder that hampers an adequate adherence to the intervention program
  • Other vascular diseases: rheumatologic/ autoimmune disorders, thrombopathies, hemophilia.
  • Active oncologic disease.
  • Treatment with corticosteroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168712


Locations
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Spain
Hospital Infanta Elena
Valdemoro, Madrid, Spain, 28342
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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Responsible Party: KOLDO VILLELABEITIA JAUREGUIZAR, Chief of Rehabilitation Department, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT02168712    
Other Study ID Numbers: EO31/2013-HIE
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014
Keywords provided by KOLDO VILLELABEITIA JAUREGUIZAR, Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
Coronary Heart Disease
Interval exercise training
Continuous exercise training
Quality of life
Safety
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases