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Trial record 1 of 1 for:    NCT02224495
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The Effect of Exercise Training on Cardiac Structure and Function

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ClinicalTrials.gov Identifier: NCT02224495
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : August 25, 2014
Sponsor:
Collaborator:
Universidade do Porto
Information provided by (Responsible Party):
Ricardo Fontes Carvalho, Gaia Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Behavioral: Structured exercise training Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Exercise Training on Cardiac Structure and Function
Study Start Date : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity) [ Time Frame: 4 months ]
    Determined by echocardiography; results in cm/s


Secondary Outcome Measures :
  1. 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)

  2. Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity) [ Time Frame: 4 months ]
    Determined by echocardiography; results in cm/s

  3. Left ventriclular ejection fraction [ Time Frame: 4 months ]
    Determined by echocardiography; results in %



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224495


Locations
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Portugal
Cardiology Department Gaia Hospital Center
Gaia, Portugal, 4450-189
Sponsors and Collaborators
Gaia Hospital
Universidade do Porto
Investigators
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Study Director: Adelino Leite-Moreira, PhD Universidade do Porto

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ricardo Fontes Carvalho, MD, PhD, Gaia Hospital
ClinicalTrials.gov Identifier: NCT02224495     History of Changes
Other Study ID Numbers: ET2011
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: August 25, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases