Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01887080
• Other study ID #: AN-002
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: January 29, 2014
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: Escola Superior de Tecnologia da Saúde do Porto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

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.

Locations

Country	Name	City	State
Portugal	Andreia Noites	Porto	Vila Nova de Gaia

Sponsors (1)

Lead Sponsor	Collaborator
Escola Superior de Tecnologia da Saúde do Porto

Country where clinical trial is conducted

Portugal, 

References & Publications (3)

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 rega — View Citation

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. — View Citation

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. Resist — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Food Frequency Questionnaire	Food Frequency Questionnaire was used to monitor lifestyle during sessions.	Change from Baseline in Food Frequency Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Other	International Physical Activity Questionnaire	Moderate physical activity level was used to monitor lifestyle during sessions	Change from Baseline in International Physical Activity Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Other	Depression Anxiety Stress Scales (DASS-21)	Depression Anxiety Stress Scales was used to monitor lifestyle during sessions	Change from Baseline in DASS-21 at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Other	MacNew Heart Disease health-related quality of life instrument	MacNew was used to monitor lifestyle during sessions	Change from Baseline in MacNew at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Other	EuroQoL Quality of Life Scale (EQ-5D)	EQ-5D was used to monitor lifestyle during sessions	Change from Baseline in EQ-5D at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Other	Montreal Cognitive Assessment(MOCA)	Moca was used to monitor lifestyle during sessions	Change from Baseline in MOCA at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Other	Transtheoretical Model Exercise Behavior	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	Change from Baseline in Transtheoretical Model Exercise Behavior at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes