Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

NCT ID: NCT01887080

Last Updated: 2014-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

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.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Exercise

Experimental group 1 performed cardiovascular rehabilitation home-based program

Group Type EXPERIMENTAL

Exercise

Intervention Type 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.

Cardiovascular Risk Factors

Intervention Type OTHER

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

Exercise afther Microcurrent

Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Cardiovascular Risk Factors

Education about risk factors

Group Type OTHER

Cardiovascular Risk Factors

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DEVICE

Cardiovascular Risk Factors

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

Intervention Type OTHER

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Escola Superior de Tecnologia da Saúde do Porto

OTHER

Sponsor Role lead

Responsible Party

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Andreia Noites

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreia Noites, MSc

Role: PRINCIPAL_INVESTIGATOR

Escola Superior de Tecnologia da Saúde do Porto

Carla Patricia Freitas, MSc

Role: PRINCIPAL_INVESTIGATOR

Escola Superior de Tecnologia da Saúde do Porto

Joana Moura Pinto, MSc

Role: PRINCIPAL_INVESTIGATOR

Escola Superior de Tecnologia da Saúde do Porto

Locations

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Andreia Noites

Porto, Vila Nova de Gaia, Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type RESULT
PMID: 17638929 (View on PubMed)

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.

Reference Type RESULT
PMID: 21609289 (View on PubMed)

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.

Reference Type RESULT
PMID: 19127177 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27743855 (View on PubMed)

Other Identifiers

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AN-002

Identifier Type: -

Identifier Source: org_study_id

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