Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

NCT01887080 | Completed DMC

• 1 other identifier: AN-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Myocardial Infarction

Keywords

Cardiovascular rehabilitation home-based; Acute myocardial infarction; Obesity; Microcurrent

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (7)

• Bioimpedance values

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

• Perimeters measurements

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

• Skinfolds measurements

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

• Daily Physical Activity

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

• Flexicurve spinal measurement

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

Other Outcomes (7)

• Food Frequency Questionnaire

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

• International Physical Activity Questionnaire

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

• Depression Anxiety Stress Scales (DASS-21)

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

Study Arms (3)

Exercise

EXPERIMENTAL

Experimental group 1 performed cardiovascular rehabilitation home-based program

Other: Exercise; Other: Cardiovascular Risk Factors

Exercise afther Microcurrent

EXPERIMENTAL

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

Other: Exercise; Device: Microcurrent; Other: Cardiovascular Risk Factors

Cardiovascular Risk Factors

OTHER

Education about risk factors

Other: Cardiovascular Risk Factors

Interventions

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.

Exercise; Exercise afther Microcurrent

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.

Exercise afther Microcurrent

Cardiovascular Risk Factors OTHER

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

Cardiovascular Risk Factors; Exercise; Exercise afther Microcurrent

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escola Superior de Tecnologia da Saúde do Porto: lead

Study Sites (1)

Andreia Noites

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

Location

Related Publications (4)

• 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.

  PMID: 17638929 RESULT

• 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.

  PMID: 21609289 RESULT

• 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.

  PMID: 19127177 RESULT

• 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.

  PMID: 27743855 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Exercise; Heart Disease Risk Factors

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Risk Factors; Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 26, 2013
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 30, 2014

Record last verified: 2014-01

Locations

PT (1)