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The Effect of Exercise Training on Cardiac Structure and Function

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 1
Locations
Portugal
Study Type
Interventional
Intervention
Structured exercise training
Sponsored by
Gaia Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Cardiology Department Gaia Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Structured exercise training

Arm Description

Standard of care

8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training

Outcomes

Primary Outcome Measures

Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
Determined by echocardiography; results in cm/s

Secondary Outcome Measures

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

Full Information

First Posted
August 21, 2014
Last Updated
August 21, 2014
Sponsor
Gaia Hospital
Collaborators
Universidade do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT02224495
Brief Title
The Effect of Exercise Training on Cardiac Structure and Function
Official Title
The Effect of Exercise Training on Cardiac Structure and Function
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaia Hospital
Collaborators
Universidade do Porto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Standard of care
Arm Title
Structured exercise training
Arm Type
Experimental
Arm Description
8-week outpatient exercise-training program, encompassing 3 sessions per week, including endurance and resistance training
Intervention Type
Behavioral
Intervention Name(s)
Structured exercise training
Primary Outcome Measure Information:
Title
Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)
Description
Determined by echocardiography; results in cm/s
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)
Description
Determined by echocardiography; no unit (ratio)
Time Frame
4 months
Title
Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)
Description
Determined by echocardiography; results in cm/s
Time Frame
4 months
Title
Left ventriclular ejection fraction
Description
Determined by echocardiography; results in %
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adelino Leite-Moreira, PhD
Organizational Affiliation
Universidade do Porto
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology Department Gaia Hospital Center
City
Gaia
ZIP/Postal Code
4450-189
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
25872588
Citation
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.
Results Reference
derived

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The Effect of Exercise Training on Cardiac Structure and Function

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