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

Interval Versus Continuous Exercise Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease: a Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Other: Interval exercise training; Other: Moderate continuous exercise training

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Valdemoro, Madrid, Spain, 28342
      • Hospital Infanta Elena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on functional capacity	Basal and peak oxygen consumption values will be measured.	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	Quality of life will be compared between the two arms with one generic questionnaire (SF-36) and one ischemic heart disease specific questionnaire (MacNew)	2 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	The incidence of cardiovascular adverse events in each group will be compared	2 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: June 18, 2014
• First Posted (Estimate): June 20, 2014

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Quality of life; Coronary Heart Disease; Continuous exercise training; Interval exercise training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: EO31/2013-HIE