Body Composition of Individuals With Cardiovascular Diseases

May 29, 2017 updated by: Ana Paula Coelho Figueira Freire, Universidade do Oeste Paulista

Body Composition of Individuals With Cardiovascular Diseases Submitted to Conventional Cardiac or Virtual Reality Rehabilitation: A Randomized Clinical Trial

Introduction: Cardiovascular diseases are the leading cause of death in the world, thus, rehabilitation programs are essential to improve symptoms and reduce mortality. Virtual reality presents itself as a new alternative of therapeutic resource, stimulating the practice of physical activity through interaction between man and machine, based on the use of games and virtual environments. Objective: To compare the body composition of individuals with cardiovascular diseases submitted to conventional cardiac or virtual reality rehabilitation. Methods: Twenty-four individuals with cardiovascular diseases, divided into a conventional rehabilitation group (GRC) or virtual reality rehabilitation group (GRV), will be evaluated, and undergo a rehabilitation program for a period of 8 weeks, with two weekly sessions lasting 60 minutes. For the GRV training, the Xbox 360® from Microsoft with Kinect™ will be used with the games YourShape™ (Fitness Evolved) and Dance Central 3™. For the GRC training, treadmills (embreex) will be used to perform the aerobic training and free weights and weight training equipment to perform the resistance training. Food frequency will be evaluated by means of the Food Frequency Questionnaire, food consumption by the 24-hour food recall, body composition by bioimpedance, and functional capacity by the six-minute walk test. For analysis of data normality the Shapiro Wilk test will be applied. For paired analysis, the Student's T test will be performed in case of normal distribution or the Wilcoxon test for variables that do not follow Gaussian distribution. The intergroup comparisons will be analyzed through absolute variation before and after the interventions and the unpaired Student's T test or Mann Whitney test applied according to the normality of the data. The level of significance adopted will be 5%.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Materials and methods Ethical aspects Participants included in the study will be instructed in relation to all procedures that will be performed and sign the informed consent form agreeing to participate in the study (Annex 1), which was approved by the Institutional Ethics Committee (CAAE: CAAE 62437816.4.0000.5515,protocol number 1.865.530) and is in line with CONEP resolution 466/2012.

Experimental design In the first instance, the patients will perform an initial evaluation (Appendix 2) for the detection of comorbidities, diagnosis identification, clinical history, and collection of drug data. The following will be evaluated before and after 8 weeks of intervention: food frequency, food consumption, anthropometric variables, abdominal circumference, body composition, glycemic behavior, and functional capacity.

Food frequency The Food Frequency Questionnaire (FFQ) will be used to analyze the periodicity of food consumption. The FFQ has a space that contains the food and another for the respondent to register how often they consume this food. The frequency is recorded in units of time: days, weeks, months, years, according to the needs of the evaluation. It is considered a practical and easily applied questionnaire, besides being important for studies that associate diet with chronic diseases .

Food consumption The 24-hour food recall (R24h) will be used to measure the current food consumption of the individuals. The R24h is a quantitative assessment of food and beverage intake. It provides detailed information on weight and total volume of portions consumed in the previous 24 hours. This method aims to evaluate the current diet and estimate absolute or relative values of nutrient intake, according to the total of the foods offered to the individual. The recall will be completed by the patients for three consecutive days.

Anthropometric variables Weight and height will be evaluated through anthropometry, using a Filizola® scale (accuracy of 100g), with the patient wearing light, comfortable clothes and barefoot. Height will be measured using a Filizola® stadiometer (0.1 cm accuracy) with the patient barefoot, in the orthostatic position, their back to the marker, feet together, head adjusted to the Frankfurt plane, and the metal bar on the patient's head. The body mass index (BMI) will be calculated based on the patient's weight and height, through the weight / height ratio.

Abdominal circumference The abdominal circumference will be obtained using a non-distensible tape measure (accuracy of 1 mm). With the individual in the orthostatic position, feet parallel, upper limbs relaxed and alongside the trunk, the tape measure will be positioned at the height of the iliac crest and immediately above the umbilical scar, without compressing the skin. The measurement will be performed 3 times and the lowest value selected for the study.

Body composition Body composition will be evaluated using Tetrapolar Bioimpedance Apparatus (BIA), Biodynamics® Model 310e, in which weight and percentage of body fat and fat free weight (muscles, bones, and organs) will be analyzed and quantified. The BIA will be performed in the morning and patients will be required to be in a fasting state, empty their bladder prior to the test, discontinue diuretic medication 24 hours prior to the test, refrain from drinking alcohol and caffeine for 24 hours prior to the examination, and not perform intense physical activity for 72 hours before the evaluation. The BIA will not be performed on patients with pacemakers or those with unstable heart failure, as alterations in volume could interfere with the results.

Glycemic behavior Verification of capillary glycemia will be carried out using a glycosimeter, brand OptiumXceed®, that determines glucose in fresh capillary blood, collected by puncturing the digital pulp of the ring finger using sterile lancet blades. The collections will be carried out individually, before and after the training.

Functional capacity Functional capacity will be evaluated through the 6-minute Walk Test (WT6') performed according to the criteria established by the American Thoracic Society. The WT6' will be performed in a hall of the gymnasium at the Universidade do Oeste Paulista, Presidente Prudente/SP- Brazil.

Cardiovascular parameters Heart rate will be measured using a Sigma® heart rate monitor. Oxygen saturation will be verified through a Choicemmed® brand pulse oximeter, model Md300c1. Blood pressure will be checked with the patient seated, in the dominant arm, using a Premium® brand aneroid sphygmomanometer and Littman® brand stethoscope, according to the Brazilian arterial hypertension guidelines.

Training protocol For both groups the training protocol will consist of 2 weekly sessions, lasting 60 minutes, for a period of 8 weeks in the Physical Therapy Clinic of the Universidade do Oeste Paulista, Presidente Prudente/SP, Brazil, totaling sixteen sessions. The initial and final 5 minutes of each session will be used to measure blood pressure, blood glucose, and O2 saturation, and apply the Borg scale of subjective effort. Throughout all sessions, the Borg scale of subjective effort and heart rate will also be verified to ensure that the training heart rate, calculated individually according to the Karvonen formula, is not exceeded.

For the GVR training, Microsoft's Xbox 360® will be used with Kinect™, which features an infrared camera sensor that recognizes user movements without a controller. The games used will be YourShape™(Fitness Evolved) and Dance Central 3™, which will be played for 25 minutes each; the former will be associated with the use of Velcro weights on the ankles and dumbbells in the hands to provide resistance.

For the GRC training, treadmills (embreex) will be used to perform the aerobic training for a period of 30 minutes and free weights and weight training equipment for the resistance training, which will be carried out in 3 sets of 10 repetitions, with a recovery interval of 1 minute between sets. The exercises performed will be shoulder abduction, elbow flexion, and knee extension and flexion, all performed in the seated position, with the exception of the knee flexion which will be performed in the orthostatic position. The increase in resistance will be carried out in an individualized way based on the Borg sensation of effort (13- slightly tiring).

Statistical analysis The data will be analyzed using the statistical software GraphPadPrism. For analysis of data normality the Shapiro Wilk test will be applied. For paired analysis, the Student's T test will be performed in case of normal distribution or the Wilcoxon's test for variables that do not follow Gaussian distribution. The intergroup comparisons will be analyzed by absolute variation before and after the interventions and the unpaired Student's T test or Mann Whitney test applied according to normality of the data. The level of significance used will be 5%.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Presidente Prudente, SP, Brazil, 19050070
        • Ana Paula Coelho Figueira Freire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individuals over 45 years of age,
  • Both genders,
  • Presenting cardiovascular diseases (coronary insufficiency, postoperative myocardial revascularization, acute myocardial infarction, systemic arterial hypertension, and diabetes mellitus)
  • Patients hemodynamically stable,
  • Not participated in previous rehabilitation programs for the last year,
  • Not present arteriopathies or muscular or orthopedic alterations.

Exclusion Criteria:

  • Decompensation during the training protocol,
  • Patients who do not adapt to the training,
  • Patients a participation frequency of less than 75%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Virtual Reality
Microsoft's Xbox 360® will be used with Kinect™,
Behavioral: Virtual Reality
For the VRG training, Microsoft's Xbox 360® will be used with Kinect™, which features an infrared camera sensor that recognizes user movements without a controller. The games used will be YourShape™(Fitness Evolved) and Dance Central 3™, which will be played for 25 minutes each; the former will be associated with the use of Velcro weights on the ankles and dumbbells in the hands to provide resistance.
Other Names:
  • Experimental: Virtual Reality
Active Comparator: Conventional Training
treadmills (embreex) will be used to perform the aerobic training for a period of 30 minutes and free weights and weight training equipment for the resistance training
Behavioral: Conventional Training
treadmills (embreex) will be used to perform the aerobic training for a period of 30 minutes and free weights and weight training equipment for the resistance training, which will be carried out in 3 sets of 10 repetitions, with a recovery interval of 1 minute between sets.
Other Names:
  • Active Comparator: Conventional Training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in percentual of body fat
Time Frame: Baseline and 8 weeks of training
Body composition
Baseline and 8 weeks of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in fat free weight
Time Frame: Baseline and 8 weeks of training
Body composition
Baseline and 8 weeks of training

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in abdominal circumference
Time Frame: Baseline and 8 weeks of training
Mesurement of abdmominal region
Baseline and 8 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade do Oeste Paulista

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 35632017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No plans for sharing data with other reserarchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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