Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

Study Overview
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Brief Summary
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The aim of this study was to investigate the effects of electric stimulation (electrolipolysis) in a home-based cardiovascular rehabilitation program in patients with acute myocardial infarction

Detailed Description
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Cardiovascular disease is the leading cause of death in most industrialized countries. It is widely accepted that cardiac rehabilitation has a beneficial role in the control of modifiable cardiovascular risk factors. However, these cardiovascular rehabilitation programs are scarce and only a small fraction of the population who needs has access. So, it is pertinent to the displacement of these programs to the community context. Obesity has become a truly global epidemic among children and adults, as well as changing the metabolic profile: when occurs an excessive accumulation of adipose tissue (mainly central distribution) there are a set of changes / adjustments to the cardiac structure and function. The electrical stimulation of abdominal subcutaneous (electrolipolysis) is a procedure often used in physical therapy clinics to reduce waist circumference. However, the effectiveness of this intervention, the selection of parameters, and the duration of its effects in cardiac patients are not yet clarified in the literature.

Official Title
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Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program in Patients With Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Other: Exercise
* Device: Microcurrent
* Other: Cardiovascular Risk Factors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals admitted to the coronary care unit for acute myocardial infarction for more than one year; Individuals of both sexes; Ages between 40 and 75 years; Heart disease stabilized; Motivation to perform physical activity for 8 weeks; Cognitive level sufficient to understand the particulars of the study. Exclusion Criteria: Contraindications of micro-current (pacemaker, osteosynthesis material, tumor areas and open wounds or skin changes in the abdominal region); Pregnant at the time, in the preceding 6 months or wishing to become pregnant during the intervention period; Neurological, musculoskeletal or respiratory disorders; Individuals who are to carry out other therapies.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Experimental group 1 performed cardiovascular rehabilitation home-based program | Other: Exercise<br>* This group had the exercise program, thrice a week for eight weeks. The exercise protocol consists of 10 exercises: aerobic and resistance exercises. It was used a moderate intensity (60% of maximum heart rate of stress test with progression until 80%). Subjects were taught to monitor exercise intensity by measuring the manual heart rate, by using the scale of perceived exertion Borg (11-13), and by observation of signs. The exercise protocol was done with supervision from a distance, using information technologies (SMS, phone, email ...), and when necessary it was resorted to routine meetings.<br>Other: Cardiovascular Risk Factors<br>* It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.<br>|
| Experimental: Exercise afther Microcurrent<br>Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent. | Other: Exercise<br>* This group had the exercise program, thrice a week for eight weeks. The exercise protocol consists of 10 exercises: aerobic and resistance exercises. It was used a moderate intensity (60% of maximum heart rate of stress test with progression until 80%). Subjects were taught to monitor exercise intensity by measuring the manual heart rate, by using the scale of perceived exertion Borg (11-13), and by observation of signs. The exercise protocol was done with supervision from a distance, using information technologies (SMS, phone, email ...), and when necessary it was resorted to routine meetings.<br>Device: Microcurrent<br>* This group had the exercise program after electrolipolysis, thrice a week for eight weeks. The electrolipolysis consisted of 30-minute sessions: the first 15 minutes with a frequency of 30 Hz and the final 15 minutes with a frequency of 10 Hz; with a pulse time of 10 ms; and an intensity below the threshold of sensitivity (with a maximum of 750 μA). There were used 4 transcutaneous electrodes in the abdominal region (parallel position). Microcurrent was done with supervision from a distance, using information technologies (SMS, phone, email ...), and when necessary it was resorted to routine meetings.<br>Other: Cardiovascular Risk Factors<br>* It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.<br>|
| Other: Cardiovascular Risk Factors<br>Education about risk factors | Other: Cardiovascular Risk Factors<br>* It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory Fitness | The stress test was performed according to the Bruce protocol on a treadmill. The test begins with the treadmill set to a low speed (2.7 km/h) and a 10% incline, and every 3 minutes the speed and angle of incline are increased. Generally the incline is increased by 2% at every level, until exhaustion. It was measured resting, maximum and recovery heart rate; resting, maximum and recovery systolic blood pressure; resting, maximum and recovery diastolic blood pressure; resting, maximum and recovery double product; time and recovery time; speed; slope; and changes in functional capacity. | Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program | 
| Blood tests | They were performed in the morning after fasting for about 12 hours, to avoid the interference of postprandial lipemia. It was measured glucose, cholesterol and triglycerides. | Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program | 
| Computerized axial tomography | It was measured subcutaneous, visceral and total abdominal fat. | Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioimpedance values | I twas used a bioimpedance scale (BIO) InnerScan Tanita, TBF-300A, which uses four electrodes (two on each foot) for the passage of an electric current. People were told to undress her clothes and stay only shorts without metal objects. | Change from Baseline in Bioimpedance values at 8 weeks of Cardiac Rehabilitation Home-Based Program and 4 Weeks After Finishing the Protocol | 
| Perimeters measurements | The perimeters measurements were done, at the end of expiration, at waist level (below last rib), at navel level, at the point immediately above the iliac crests and at trochanters level. The waist-hip ratio was calculated using the waist level perimeter divided by trochanters level perimeter | Change from Baseline in Perimeters measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol | 
| Skinfolds measurements | Subscapular, Triceps, Biceps, Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by Harpenden Caliper | Change from Baseline in Skinfolds measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol | 
| Daily Physical Activity | Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT3X, Florida, USA). | Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol | 
| Flexicurve spinal measurement | It was proceeded 3 measurements with flexicurve, with references of C7 and L1 to calculate the thoracic index. | Change from Baseline in Flexicurve Spinal Measurement at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol | 
| Y-Balance Test | The Y-balance test assesses anterior, posteromedial and posterolateral components. | Change from Baseline in Y-Balance Test at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol | 
| One Leg Standing Test | It was recorded the best time, for two lower extremities (until the maximum of 30 seconds), without unbalancing . It was made with the eye open and closed. | Change from Baseline in One Leg Standing Test at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiovascular rehabilitation home-based, Acute myocardial infarction, Obesity, Microcurrent