Recent Myocardial Infarction Clinical Trial
Official title:
Effects of Interval Physical Training on Inflammatory Markers, Cardiac Autonomic Modulation at Rest, Expiratory Flow Limitation and Respiratory Efficiency in Recent Myocardial Infarction
Introduction: Expiratory flow limitation (EFL) and ventilatory inefficiency during dynamic
exercise have been identified in patients with recent myocardial infarction (RMI) with
preserved ventricular and pulmonary function. However, it is not known what is the prevalence
of EFL in this population and what are the effects of physical and respiratory training on
this limitation.
Objectives: To evaluate the prevalence of EFL and ventilatory inefficiency during dynamic
exercise in individuals with uncomplicated RMI, and to evaluate the effects of interval
physical training (IT) in addition to inspiratory muscle training (IMT), exclusive IT and
absence of cardiopulmonary rehabilitation (CR) on EFL and ventilatory efficiency.
Methods: 54 patients will be included, divided into three groups with 18 participants each.
All will be submitted to evaluations of heart rate variability, hematological and biochemical
profile, erythrocytes membrane deformability and stability, inflammatory markers, respiratory
pressures, plethysmography, spirometry, carbon monoxide diffusion capacity, ankle brachial
index, electrical bioimpedance, echocardiogram, quality of life questionnaires,
cardiopulmonary exercise testing and constant load tests. Then, groups 1 (IT) and group 2 (IT
+ IMT) will participate in a physical training program for 12 weeks and will be re-evaluated
after this period. In addition, they will be monitored for a 6 month period after discharge,
with returns every two months to measure the energy expenditure through an accelerometer, and
at the end of this period they will repeat all the tests again. Group 3 (absence of CR), will
consist of patients who do not live in the city or those who can not participate in the CR
program for any other reason, and will only participate in the evaluations.
Patients with coronary artery disease (CAD) attended by the Sistema Unico de Saude (SUS) in
the city of Uberlandia and region are routinely referred to Hospital de Clinicas - Federal
University of Uberlandia after acute myocardial infarction (AMI) for coronary angiography and
other exams, receiving appropriate clinical or surgical follow-up. After the resolution of
the clinical condition, the patient is released from the hospital with a medical referral to
the Cardiorespiratory Rehabilitation Program offered by the institution.
These patients are contacted by telephone by the team of the rehabilitation sector, and
invited to attend for a pre-entry evaluation for inclusion in treatment. In this telephone
contact the secretary of the sector clarifies that the hospital does not have transportation
services for the patients who accept to be part of the program, and afterwards the evaluation
is scheduled. The initial anamnesis will be performed by a multidisciplinary team. In this
screening are collected complaints, past and current history of possible diseases, personal
and family history, life habits, medications in use, exams performed pre-hospital discharge
and physical examination, collected from an individual anamnesis form. At the end of the
evaluation the patient receives a card with the scheduling of training days that occur three
times a week and dressing and feeding instructions prior to training.
All volunteers who fit the study criteria will be invited to participate in the study, being
informed about the experimental procedures to which they would be submitted. They will also
be clarified that all the information collected during the accomplishment of the work will be
kept confidential, protecting their identities. Individuals who agree to participate in the
study will sign an informed consent according to National Health Council (466/12) guidelines,
and a next return will be scheduled to begin physical testing and blood collection. At that
moment, the Research Participant Identification Card will be filled in, which will be kept in
a confidential place separated from the other evaluations, with restricted access to the
researcher, and a code will be given to the participant. In case of refusal to participate in
the study, the participant will receive the same care offered to other patients routinely
referred to the rehabilitation sector, being included into the conventional rehabilitation
program that also lasts for 12 weeks.
Considering that the patients enrolled in the research will have to attend for evaluation and
monitoring related to the study, all the displacements related to these additional activities
will be refunded to the participants during the entire period of the study.
The evaluation procedures that will be performed in 2 days will consist of: Step 1 - ankle
brachial index, heart rate variability at rest, respiratory pressures (maximal inspiratory
and expiratory pressures), cardiopulmonary exercise test (incremental and constant load
tests), spirometry and quality of life questionnaires (SF-36 and MacNew QLMI); Step 2 - blood
collection (hematological and biochemical profile, erythrocytes membrane deformability and
stability, inflammatory markers), plethysmography, carbon monoxide diffusion capacity and
echocardiography.
After these exams the participant will be randomized to a training group: Group 1 - interval
training (IT) or group 2 - IT + inspiratory muscle training (IMT), and will participate in
the cardiorespiratory rehabilitation program for a period of 12 weeks, three times a week.
Group 3 will consist of those participants who for any reason do not agree to participate in
the rehabilitation program, such as those who do not live in the city, and will remain
without intervention.
During the 6 months of discharge, participants will be monitored monthly, by telephone
contact to verify possible changes in medications in use and general health status.
At the end of the 2nd, 4th and 6th month of discharge, in the last week of each period, the
patient will be invited to return to the rehabilitation sector for placement of an
accelerometer, a monitor that quantifies free activities and sedentary lifestyle. The
selected equipment (activPAL3 ™ micro, PAL Technologies Ltd, Scotland, UK) makes use of
algorithms properties to quantify periods of sitting, orthostatism and walking. This
information will be used to estimate the daily energy expenditure in the period and will
store information of seven consecutive days during the selected weeks.
The re-evaluations will consist of all the exams mentioned above (steps 1 and 2), and will be
performed at the beginning and at the end of the training period and after 6 months of the
program's discharge.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00893360 -
CArdiosphere-Derived aUtologous Stem CElls to Reverse ventricUlar dySfunction
|
Phase 1 |