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The Effect of Exercise Training on Cardiac Structure and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 21, 2014
First Posted Date  ICMJE August 25, 2014
Last Update Posted Date August 25, 2014
Study Start Date  ICMJE September 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity) [ Time Frame: 4 months ]
Determined by echocardiography; results in cm/s
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2014)
  • 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)
  • Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity) [ Time Frame: 4 months ]
    Determined by echocardiography; results in cm/s
  • Left ventriclular ejection fraction [ Time Frame: 4 months ]
    Determined by echocardiography; results in %
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Exercise Training on Cardiac Structure and Function
Official Title  ICMJE The Effect of Exercise Training on Cardiac Structure and Function
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE Behavioral: Structured exercise training
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Structured exercise training
Publications * Fontes-Carvalho R, Sampaio F, Teixeira M, Gama V, Leite-Moreira AF. The role of a structured exercise training program on cardiac structure and function after acute myocardial infarction: study protocol for a randomized controlled trial. Trials. 2015 Mar 12;16:90. doi: 10.1186/s13063-015-0612-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2014)
200
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Portugal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02224495
Other Study ID Numbers  ICMJE ET2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ricardo Fontes Carvalho, Gaia Hospital
Study Sponsor  ICMJE Gaia Hospital
Collaborators  ICMJE Universidade do Porto
Investigators  ICMJE
Study Director: Adelino Leite-Moreira, PhD Universidade do Porto
PRS Account Gaia Hospital
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP