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Acute Myocardial InfarctionNCT01887080

Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

A study testing Exercise, Microcurrent and Cardiovascular Risk Factors in people with Acute Myocardial Infarction, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Exercise, Microcurrent and Cardiovascular Risk Factors
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 sitePortugal
Study dates
Sep 2012to Sep 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Portugal1 site

  • Andreia Noites

    Porto, Vila Nova de Gaia, 4400-303

Other trials in Portugal

About this study

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

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

Read the 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.

Being tested
Exercise, Microcurrent, Cardiovascular Risk Factors
Keywords
Cardiovascular rehabilitation home-based, Acute myocardial infarction, Obesity, Microcurrent
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    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.

  • MicrocurrentDevice

    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 FactorsOther

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

Study groups in NCT01887080
Study groupRoleWhat they receive
ExerciseExperimentalExperimental group 1 performed cardiovascular rehabilitation home-based program
Receives: Other: Exercise; Other: Cardiovascular Risk Factors
Exercise afther MicrocurrentExperimentalExperimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.
Receives: Other: Exercise; Device: Microcurrent; Other: Cardiovascular Risk Factors
Cardiovascular Risk FactorsOtherEducation about risk factors
Receives: Other: Cardiovascular Risk Factors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. Computerized axial tomography

    It was measured subcutaneous, visceral and total abdominal fat.

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

Secondary outcomes (7)

  1. 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.

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

  2. 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

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

  3. Skinfolds measurements

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

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

  4. Daily Physical Activity

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

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

  5. Flexicurve spinal measurement

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

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

  6. Y-Balance Test

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

    Measured: 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

  7. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2013 (estimated)
  2. Study startSep 2012
  3. Primary completionJul 2013
  4. Study completionSep 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01887080
Sponsor's protocol ID
AN-002
Status last verified
Jan 2014
First submitted
18 Jun 2013
Last updated
30 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Williams MA, Haskell WL, Ades PA, Amsterdam EA, Bittner V, Franklin BA, Gulanick M, Laing ST, Stewart KJ; American Heart Association Council on Clinical Cardiology; American Heart Association Council on Nutrition, Physical Activity, and Metabolism. Resistance exercise in individuals with and without cardiovascular disease: 2007 update: a scientific statement from the American Heart Association Council on Clinical Cardiology and Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2007 Jul 31;116(5):572-84. doi: 10.1161/CIRCULATIONAHA.107.185214. Epub 2007 Jul 16.

    PubMed 17638929

  • Hamida ZH, Comtois AS, Portmann M, Boucher JP, Savard R. Effect of electrical stimulation on lipolysis of human white adipocytes. Appl Physiol Nutr Metab. 2011 Apr;36(2):271-5. doi: 10.1139/h11-011.

    PubMed 21609289

  • Donnelly JE, Blair SN, Jakicic JM, Manore MM, Rankin JW, Smith BK; American College of Sports Medicine. American College of Sports Medicine Position Stand. Appropriate physical activity intervention strategies for weight loss and prevention of weight regain for adults. Med Sci Sports Exerc. 2009 Feb;41(2):459-71. doi: 10.1249/MSS.0b013e3181949333.

    PubMed 19127177

  • Noites A, Freitas CP, Pinto J, Melo C, Vieira A, Albuquerque A, Teixeira M, Ribeiro F, Bastos JM. Effects of a Phase IV Home-Based Cardiac Rehabilitation Program on Cardiorespiratory Fitness and Physical Activity. Heart Lung Circ. 2017 May;26(5):455-462. doi: 10.1016/j.hlc.2016.08.004. Epub 2016 Sep 13.

    PubMed 27743855

Questions about this trial

What is this clinical trial studying?

A study testing Exercise, Microcurrent and Cardiovascular Risk Factors in people with Acute Myocardial Infarction, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiorespiratory Fitness (time frame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01887080, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2014.

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