The Effect of Exercise Training on Cardiac Structure and Function

NCT ID: NCT02224495

Last Updated: 2014-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

Standard of care

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Structured exercise training

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

Group Type EXPERIMENTAL

Structured exercise training

Intervention Type BEHAVIORAL

Interventions

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Structured exercise training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade do Porto

OTHER

Sponsor Role collaborator

Gaia Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ricardo Fontes Carvalho

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adelino Leite-Moreira, PhD

Role: STUDY_DIRECTOR

Universidade do Porto

Locations

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Cardiology Department Gaia Hospital Center

Gaia, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type DERIVED
PMID: 25872588 (View on PubMed)

Other Identifiers

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ET2011

Identifier Type: -

Identifier Source: org_study_id

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