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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02168712
• Other study ID #: EO31/2013-HIE
• Status: Completed
• Phase: N/A
• First received: June 16, 2014
• Last updated: June 18, 2014
• Start date: November 2011
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Moderate continuous exercise training

• Interval exercise training

Locations

Country	Name	City	State
Spain	Hospital Infanta Elena	Valdemoro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Adverse Events	The incidence of cardiovascular adverse events in each group will be compared	2 months	Yes
Primary	Impact on functional capacity	Basal and peak oxygen consumption values will be measured.	2 months	No
Secondary	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	No