The Effect of Exercise Training on Cardiac Structure and Function

NCT02224495 | Completed Phase 1

• 1 other identifier: ET2011
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Myocardial early diastolic velocity at mitral annulus by tissue Doppler (E' velocity)

  Determined by echocardiography; results in cm/s

  4 months

Secondary Outcomes (3)

• Ratio between early diastolic filling velocity from mitral inflow and myocardial early diastolic velocity at mitral annulus by tissue Doppler (E/E' ratio)

  4 months

• Myocardial systolic velocity at mitral annulus by tissue Doppler (S' velocity)

  4 months

• Left ventriclular ejection fraction

  4 months

Study Arms (2)

Control

PLACEBO COMPARATOR

Standard of care

Structured exercise training

EXPERIMENTAL

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

Behavioral: Structured exercise training

Interventions

Structured exercise training BEHAVIORAL

Structured exercise training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients one month after myocardial infarction
• Older 18 years

You may not qualify if:

• 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).

Sponsors & Collaborators

• Gaia Hospital: lead
• Universidade do Porto: collaborator

Study Sites (1)

Cardiology Department Gaia Hospital Center

Gaia, 4450-189, Portugal

Location

Related Publications (1)

• 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.

  PMID: 25872588 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Adelino Leite-Moreira, PhD

  Universidade do Porto

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 25, 2014
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: May 1, 2013
• Last Updated: August 25, 2014

Record last verified: 2014-08

Locations

PT (1)