The Effect of Exercise Training on Cardiac Structure and Function

August 21, 2014 updated by: Ricardo Fontes Carvalho, Gaia Hospital

Exercise training, as part of cardiac rehabilitation, is effective in improving functional capacity and quality of life in patients with coronary artery disease. Other cardiovascular and non-cardiovascular benefits have been reported, namely in glucose metabolism, skeletal muscle function, oxidative stress, vascular function, pulmonary circulation, ischaemia-reperfusion lesion and ventricular remodelling.

However, the benefit of exercise training on systolic and diastolic function is controversial especially after acute myocardial infarction where no longitudinal study has evaluated diastolic function using modern echocardiographic parameters.

The hypothesis is that a structured program of exercise training can improve systolic and diastolic function in patients after myocardial infarction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Gaia, Portugal, 4450-189
        • Cardiology Department Gaia Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients one month after myocardial infarction
  • Older 18 years

Exclusion Criteria:

  • Age above 75 years,
  • Inability to exercise,
  • Hemodinamically significant valvular disease,
  • Moderate to severe chronic lung disease (vital capacity and/or forced expiratory volume in 1 s <80% of age-dependent predicted value),
  • Atrial fibrillation
  • Exercise induced myocardial ischemia
  • Anaemia (haemoglobin <12 g/dl).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
Standard of care
EXPERIMENTAL: Structured exercise training
8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training
Behavioral: Structured exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
Time Frame: 4 months
Determined by echocardiography; results in cm/s
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)
Time Frame: 4 months
Determined by echocardiography; no unit (ratio)
4 months
Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)
Time Frame: 4 months
Determined by echocardiography; results in cm/s
4 months
Left ventriclular ejection fraction
Time Frame: 4 months
Determined by echocardiography; results in %
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia Hospital

Collaborators

Universidade do Porto

Investigators

  • Study Director: Adelino Leite-Moreira, PhD, Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

August 21, 2014

First Submitted That Met QC Criteria

August 21, 2014

First Posted (ESTIMATE)

August 25, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 25, 2014

Last Update Submitted That Met QC Criteria

August 21, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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