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Completed

NCT Number: NCT01887080

Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

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

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Key information

Conditions

Acute Myocardial Infarction Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Andreia Noites

Porto, Vila Nova de Gaia, 4400-303, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Other

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.

Microcurrent

Device

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.

Cardiovascular Risk Factors

Other

It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.

Primary outcomes

  1. Cardiorespiratory Fitness

    Time frame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program

    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.

  2. Blood tests

    Time frame: Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program

    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.

  3. Computerized axial tomography

    Time frame: Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program

    It was measured subcutaneous, visceral and total abdominal fat.

Secondary outcomes

  1. Bioimpedance values

    Time frame: Change from Baseline in Bioimpedance values at 8 weeks of Cardiac Rehabilitation Home-Based Program and 4 Weeks After Finishing the Protocol

    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.

  2. Perimeters measurements

    Time frame: Change from Baseline in Perimeters measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    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

  3. Skinfolds measurements

    Time frame: Change from Baseline in Skinfolds measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Subscapular, Triceps, Biceps, Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by Harpenden Caliper

  4. Daily Physical Activity

    Time frame: Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT3X, Florida, USA).

  5. Flexicurve spinal measurement

    Time frame: Change from Baseline in Flexicurve Spinal Measurement at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    It was proceeded 3 measurements with flexicurve, with references of C7 and L1 to calculate the thoracic index.

  6. Y-Balance Test

    Time frame: 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

    The Y-balance test assesses anterior, posteromedial and posterolateral components.

  7. One Leg Standing Test

    Time frame: Change from Baseline in One Leg Standing Test at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    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.

Other outcomes

  1. Food Frequency Questionnaire

    Time frame: Change from Baseline in Food Frequency Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Food Frequency Questionnaire was used to monitor lifestyle during sessions.

  2. International Physical Activity Questionnaire

    Time frame: Change from Baseline in International Physical Activity Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Moderate physical activity level was used to monitor lifestyle during sessions

  3. Depression Anxiety Stress Scales (DASS-21)

    Time frame: Change from Baseline in DASS-21 at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Depression Anxiety Stress Scales was used to monitor lifestyle during sessions

  4. MacNew Heart Disease health-related quality of life instrument

    Time frame: Change from Baseline in MacNew at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    MacNew was used to monitor lifestyle during sessions

  5. EuroQoL Quality of Life Scale (EQ-5D)

    Time frame: Change from Baseline in EQ-5D at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    EQ-5D was used to monitor lifestyle during sessions

  6. Montreal Cognitive Assessment(MOCA)

    Time frame: Change from Baseline in MOCA at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Moca was used to monitor lifestyle during sessions

  7. Transtheoretical Model Exercise Behavior

    Time frame: Change from Baseline in Transtheoretical Model Exercise Behavior at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

    Transtheoretical Model Exercise Behavior consists of four subscales:

    • Identify the stages of exercise behavior
    • Processes of change of exercise behavior
    • Decisional balance of exercise behavior
    • Self-efficacy of exercise behavior

Sponsors and collaborators

Lead sponsor

Escola Superior de Tecnologia da Saúde do Porto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2013
Registry last updated
Jan 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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