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Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise
Microcurrent
Cardiovascular Risk Factors
Sponsored by
Escola Superior de Tecnologia da Saúde do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Cardiovascular rehabilitation home-based, Acute myocardial infarction, Obesity, Microcurrent

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Andreia Noites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Exercise

Exercise afther Microcurrent

Cardiovascular Risk Factors

Arm Description

Experimental group 1 performed cardiovascular rehabilitation home-based program

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

Education about risk factors

Outcomes

Primary Outcome Measures

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.
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.
Computerized axial tomography
It was measured subcutaneous, visceral and total abdominal fat.

Secondary Outcome Measures

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.
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
Skinfolds measurements
Subscapular, Triceps, Biceps, Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by Harpenden Caliper
Daily Physical Activity
Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT3X, Florida, USA).
Flexicurve spinal measurement
It was proceeded 3 measurements with flexicurve, with references of C7 and L1 to calculate the thoracic index.
Y-Balance Test
The Y-balance test assesses anterior, posteromedial and posterolateral components.
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.

Full Information

First Posted
June 18, 2013
Last Updated
January 29, 2014
Sponsor
Escola Superior de Tecnologia da Saúde do Porto
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1. Study Identification

Unique Protocol Identification Number
NCT01887080
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Tecnologia da Saúde do Porto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Cardiovascular rehabilitation home-based, Acute myocardial infarction, Obesity, Microcurrent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Experimental group 1 performed cardiovascular rehabilitation home-based program
Arm Title
Exercise afther Microcurrent
Arm Type
Experimental
Arm Description
Experimental group 2 performed cardiovascular rehabilitation home-based program just after microcurrent.
Arm Title
Cardiovascular Risk Factors
Arm Type
Other
Arm Description
Education about risk factors
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Device
Intervention Name(s)
Microcurrent
Intervention Description
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
Other
Intervention Name(s)
Cardiovascular Risk Factors
Intervention Description
It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness
Description
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.
Time Frame
Change from Baseline in Cardiorespiratory Fitness at 8 weeks of Cardiac Rehabilitation Home-based Program
Title
Blood tests
Description
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.
Time Frame
Change from Baseline in blood tests at 8 weeks of Cardiac Rehabilitation Home-based Program
Title
Computerized axial tomography
Description
It was measured subcutaneous, visceral and total abdominal fat.
Time Frame
Change from Baseline in Computerized axial tomography at 8 weeks of Cardiac Rehabilitation Home-based Program
Secondary Outcome Measure Information:
Title
Bioimpedance values
Description
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.
Time Frame
Change from Baseline in Bioimpedance values at 8 weeks of Cardiac Rehabilitation Home-Based Program and 4 Weeks After Finishing the Protocol
Title
Perimeters measurements
Description
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
Time Frame
Change from Baseline in Perimeters measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Skinfolds measurements
Description
Subscapular, Triceps, Biceps, Suprailiac, vertical and horizontal abdominal skinfolds were performed three times in right hemi body, by Harpenden Caliper
Time Frame
Change from Baseline in Skinfolds measurements at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Daily Physical Activity
Description
Physical activity will be objectively measured for 7 consecutive days using the ActiGraph accelerometer (model GT3X, Florida, USA).
Time Frame
Change from Baseline in Daily Physical Activity at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Flexicurve spinal measurement
Description
It was proceeded 3 measurements with flexicurve, with references of C7 and L1 to calculate the thoracic index.
Time Frame
Change from Baseline in Flexicurve Spinal Measurement at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Y-Balance Test
Description
The Y-balance test assesses anterior, posteromedial and posterolateral components.
Time Frame
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
Title
One Leg Standing Test
Description
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.
Time Frame
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 Pre-specified Outcome Measures:
Title
Food Frequency Questionnaire
Description
Food Frequency Questionnaire was used to monitor lifestyle during sessions.
Time Frame
Change from Baseline in Food Frequency Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
International Physical Activity Questionnaire
Description
Moderate physical activity level was used to monitor lifestyle during sessions
Time Frame
Change from Baseline in International Physical Activity Questionnaire at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Depression Anxiety Stress Scales (DASS-21)
Description
Depression Anxiety Stress Scales was used to monitor lifestyle during sessions
Time Frame
Change from Baseline in DASS-21 at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
MacNew Heart Disease health-related quality of life instrument
Description
MacNew was used to monitor lifestyle during sessions
Time Frame
Change from Baseline in MacNew at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
EuroQoL Quality of Life Scale (EQ-5D)
Description
EQ-5D was used to monitor lifestyle during sessions
Time Frame
Change from Baseline in EQ-5D at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Montreal Cognitive Assessment(MOCA)
Description
Moca was used to monitor lifestyle during sessions
Time Frame
Change from Baseline in MOCA at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol
Title
Transtheoretical Model Exercise Behavior
Description
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
Time Frame
Change from Baseline in Transtheoretical Model Exercise Behavior at 8 weeks of Cardiac Rehabilitation Home-based Program and 4 Weeks After Finishing the Protocol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreia Noites, MSc
Organizational Affiliation
Escola Superior de Tecnologia da Saúde do Porto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carla Patricia Freitas, MSc
Organizational Affiliation
Escola Superior de Tecnologia da Saúde do Porto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joana Moura Pinto, MSc
Organizational Affiliation
Escola Superior de Tecnologia da Saúde do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andreia Noites
City
Porto
State/Province
Vila Nova de Gaia
ZIP/Postal Code
4400-303
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
17638929
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.
Results Reference
result
PubMed Identifier
21609289
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.
Results Reference
result
PubMed Identifier
19127177
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. Erratum In: Med Sci Sports Exerc. 2009 Jul;41(7):1532.
Results Reference
result
PubMed Identifier
27743855
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.
Results Reference
derived

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Effects of Microcurrent in a Cardiovascular Rehabilitation Home-based Program

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