Clinical trial NCT01887080: Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program
Official title: Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program in Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Cardiovascular rehabilitation home-based
Acute myocardial infarction
Obesity
Microcurrent
Lead sponsor: Escola Superior de Tecnologia da Saúde do Porto
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Cardiorespiratory Fitness
timeFrame: Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program
measure: Blood tests
timeFrame: Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program
measure: Computerized axial tomography
timeFrame: Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program
Secondary outcomes:
measure: Bioimpedance values
timeFrame: Change from Baseline in Bioimpedance values at 8 weeks of Cardiac Rehabilitation Home-Based Program and 4 Weeks After Finishing the Protocol
measure: Perimeters measurements
timeFrame: Change from Baseline in Perimeters measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Skinfolds measurements
timeFrame: Change from Baseline in Skinfolds measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Daily Physical Activity
timeFrame: Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Flexicurve spinal measurement
timeFrame: Change from Baseline in Flexicurve Spinal Measurement at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Y-Balance Test
timeFrame: 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
measure: One Leg Standing Test
timeFrame: Change from Baseline in One Leg Standing Test at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Other outcomes:
measure: Food Frequency Questionnaire
timeFrame: Change from Baseline in Food Frequency Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: International Physical Activity Questionnaire
timeFrame: Change from Baseline in International Physical Activity Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Depression Anxiety Stress Scales (DASS-21)
timeFrame: Change from Baseline in DASS-21 at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: MacNew Heart Disease health-related quality of life instrument
timeFrame: Change from Baseline in MacNew at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: EuroQoL Quality of Life Scale (EQ-5D)
timeFrame: Change from Baseline in EQ-5D at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Montreal Cognitive Assessment(MOCA)
timeFrame: Change from Baseline in MOCA at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
measure: Transtheoretical Model Exercise Behavior
timeFrame: Change from Baseline in Transtheoretical Model Exercise Behavior at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Locations:
city: Porto
country: Portugal
facility: Andreia Noites
state: Vila Nova de Gaia
Study officials:
affiliation: Escola Superior de Tecnologia da Saúde do Porto
name: Andreia Noites, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Escola Superior de Tecnologia da Saúde do Porto
name: Carla Patricia Freitas, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Escola Superior de Tecnologia da Saúde do Porto
name: Joana Moura Pinto, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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. 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.
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.
citation: 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.
citation: 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.