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

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Moderate continuous exercise training
Interval exercise training
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary Heart Disease, Interval exercise training, Continuous exercise training, Quality of life, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Infanta Elena

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Moderate continuous exercise training

Interval exercise training

Arm Description

Moderate intensity continuous exercise training

High intensity interval exercise training

Outcomes

Primary Outcome Measures

Impact on functional capacity
Basal and peak oxygen consumption values will be measured.

Secondary Outcome Measures

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)

Full Information

First Posted
June 16, 2014
Last Updated
June 18, 2014
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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1. Study Identification

Unique Protocol Identification Number
NCT02168712
Brief Title
Interval Versus Continuous Training on Functional Capacity and Quality of Life in Patients With Coronary Artery Disease
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 Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary Heart Disease, Interval exercise training, Continuous exercise training, Quality of life, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate continuous exercise training
Arm Type
Active Comparator
Arm Description
Moderate intensity continuous exercise training
Arm Title
Interval exercise training
Arm Type
Experimental
Arm Description
High intensity interval exercise training
Intervention Type
Other
Intervention Name(s)
Moderate continuous exercise training
Intervention Type
Other
Intervention Name(s)
Interval exercise training
Primary Outcome Measure Information:
Title
Impact on functional capacity
Description
Basal and peak oxygen consumption values will be measured.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
quality of life
Description
Quality of life will be compared between the two arms with one generic questionnaire (SF-36) and one ischemic heart disease specific questionnaire (MacNew)
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Incidence of Adverse Events
Description
The incidence of cardiovascular adverse events in each group will be compared
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Hospital Infanta Elena
City
Valdemoro
State/Province
Madrid
ZIP/Postal Code
28342
Country
Spain

12. IPD Sharing Statement

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

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