Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier:
NCT01887080
First received: June 18, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Acute Myocardial Infarction
Other: Exercise
Device: Microcurrent
Other: Cardiovascular Risk Factors

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program in Patients With Acute Myocardial Infarction

Resource links provided by NLM:


Further study details as provided by Escola Superior de Tecnologia da Saúde do Porto:

Primary Outcome Measures:
  • Cardiorespiratory Fitness [ Time Frame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program ] [ Designated as safety issue: Yes ]

    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.


  • Blood tests [ Time Frame: Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program ] [ Designated as safety issue: Yes ]

    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.


  • Computerized axial tomography [ Time Frame: Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program ] [ Designated as safety issue: Yes ]
    It was measured subcutaneous, visceral and total abdominal fat.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: Yes ]
    Subscapular, Triceps, Biceps, Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by Harpenden Caliper

  • 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 ] [ Designated as safety issue: Yes ]
    Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT3X, Florida, USA).

  • 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 ] [ Designated as safety issue: Yes ]
    It was proceeded 3 measurements with flexicurve, with references of C7 and L1 to calculate the thoracic index.

  • 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 ] [ Designated as safety issue: Yes ]
    The Y-balance test assesses anterior, posteromedial and posterolateral components.

  • 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 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Food Frequency Questionnaire was used to monitor lifestyle during sessions.

  • 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 ] [ Designated as safety issue: Yes ]
    Moderate physical activity level was used to monitor lifestyle during sessions

  • 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 ] [ Designated as safety issue: Yes ]
    Depression Anxiety Stress Scales was used to monitor lifestyle during sessions

  • 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 ] [ Designated as safety issue: Yes ]
    MacNew was used to monitor lifestyle during sessions

  • 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 ] [ Designated as safety issue: Yes ]
    EQ-5D was used to monitor lifestyle during sessions

  • 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 ] [ Designated as safety issue: Yes ]
    Moca was used to monitor lifestyle during sessions

  • 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 ] [ Designated as safety issue: Yes ]

    Transtheoretical Model Exercise Behavior consists of four subscales:

    1. Identify the stages of exercise behavior
    2. Processes of change of exercise behavior
    3. Decisional balance of exercise behavior
    4. Self-efficacy of exercise behavior


Enrollment: 40
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise
Experimental group 1 performed cardiovascular rehabilitation home-based program
Other: Exercise

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.

Other: Cardiovascular Risk Factors
It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.
Experimental: Exercise afther Microcurrent
Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.
Other: Exercise

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.

Device: Microcurrent

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.

Other: Cardiovascular Risk Factors
It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.
Cardiovascular Risk Factors
Education about risk factors
Other: Cardiovascular Risk Factors
It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01887080

Locations
Portugal
Andreia Noites
Porto, Vila Nova de Gaia, Portugal, 4400-303
Sponsors and Collaborators
Escola Superior de Tecnologia da Saúde do Porto
Investigators
Principal Investigator: Andreia Noites, MSc Escola Superior de Tecnologia da Saúde do Porto
Principal Investigator: Carla Patricia Freitas, MSc Escola Superior de Tecnologia da Saúde do Porto
Principal Investigator: Joana Moura Pinto, MSc Escola Superior de Tecnologia da Saúde do Porto
  More Information

Publications:
Responsible Party: Andreia Noites, Professor, Escola Superior de Tecnologia da Saúde do Porto
ClinicalTrials.gov Identifier: NCT01887080     History of Changes
Other Study ID Numbers: AN-002
Study First Received: June 18, 2013
Last Updated: January 29, 2014
Health Authority: Portugal: Ethics Committee for Clinical Research

Keywords provided by Escola Superior de Tecnologia da Saúde do Porto:
Cardiovascular rehabilitation home-based
Acute myocardial infarction
Obesity
Microcurrent

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014