NCT02168712

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2011

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
Last Updated

June 20, 2014

Status Verified

June 1, 2014

Enrollment Period

2.4 years

First QC Date

June 16, 2014

Last Update Submit

June 18, 2014

Conditions

Keywords

Coronary Heart DiseaseInterval exercise trainingContinuous exercise trainingQuality of lifeSafety

Outcome Measures

Primary Outcomes (1)

  • Impact on functional capacity

    Basal and peak oxygen consumption values will be measured.

    2 months

Secondary Outcomes (1)

  • quality of life

    2 months

Other Outcomes (1)

  • Incidence of Adverse Events

    2 months

Study Arms (2)

Moderate continuous exercise training

ACTIVE COMPARATOR

Moderate intensity continuous exercise training

Other: Moderate continuous exercise training

Interval exercise training

EXPERIMENTAL

High intensity interval exercise training

Other: Interval exercise training

Interventions

Moderate continuous exercise training
Interval exercise training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Infanta Elena

Valdemoro, Madrid, 28342, Spain

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Rehabilitation Department

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 20, 2014

Study Start

November 1, 2011

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 20, 2014

Record last verified: 2014-06

Locations