Cardiovascular DiseasesNCT03169387
Body Composition of Individuals With Cardiovascular Diseases
A study testing Virtual Reality and Conventional Training in people with Cardiovascular Diseases and Body Composition, run by Universidade do Oeste Paulista at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Body Composition
- What is being tested?
- Virtual Reality and Conventional Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2017to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Decompensation during the training protocol,
- Patients who do not adapt to the training,
- Patients a participation frequency of less than 75%
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ana Paula Coelho Figueira Freire
Presidente Prudente, São Paulo, 19050070
Ana Paula Coelho Figuiera Freire, Professor, 551832269128, anapaulafreire@unoeste.br
About this study
Official title: 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%.
Read the 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%.
- Conditions
- Cardiovascular Diseases, Body Composition
- Being tested
- Virtual Reality, Conventional Training
- Keywords
- Virtual Reality Exposure Therapy
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityBehavioural
Also called Experimental: 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.
Conventional TrainingBehavioural
Also called 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, which will be carried out in 3 sets of 10 repetitions, with a recovery interval of 1 minute between sets.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Microsoft's Xbox 360® will be used with Kinect™, Receives: Behavioral: Virtual Reality |
| Conventional Training | Active comparator | 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 Receives: Behavioral: Conventional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentual of body fat
Body composition
Measured: Baseline and 8 weeks of training
Secondary outcomes (1)
Change in fat free weight
Body composition
Measured: Baseline and 8 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start30 Jun 2017 (estimated)
- Primary completion30 Nov 2017 (estimated)
- Study completion30 Nov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Oeste Paulista
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Paula Coelho Figueira Freire, Universidade do Oeste Paulista
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169387
- Sponsor's protocol ID
- 35632017
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for sharing data with other reserarchers
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition of Individuals With Cardiovascular Diseases Submitted to Conventional Cardiac or Virtual Reality Rehabilitation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03169387
- Acronym / sponsor ID
- 35632017
- Conditions
- Cardiovascular Diseases, Body Composition
- Keywords
- Virtual Reality Exposure Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade do Oeste PaulistaUniversity, hospital or other
- Study start
- 30 Jun 2017 (estimated)
- Primary completion
- 30 Nov 2017 (estimated)
- Study completion
- 30 Nov 2017 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: Virtual RealityMicrosoft's Xbox 360® will be used with Kinect™, |
| Conventional Training | Active comparator | Behavioral: Conventional Trainingtreadmills (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 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- Decompensation during the training protocol,
- Patients who do not adapt to the training,
- Patients a participation frequency of less than 75%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual RealityAlso: Experimental: Virtual RealityFor 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. | Behavioural | Virtual Reality |
| Conventional TrainingAlso: Active Comparator: Conventional Trainingtreadmills (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. | Behavioural | Conventional Training |
Primary outcome
Change in percentual of body fat
Time frame: Baseline and 8 weeks of training
Body composition
1 secondary outcome
Change in fat free weight
Time frame: Baseline and 8 weeks of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
- Individual participant dataSharing planned: No. No plans for sharing data with other reserarchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Conventional Training in people with Cardiovascular Diseases and Body Composition, run by Universidade do Oeste Paulista at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentual of body fat (time frame: Baseline and 8 weeks of training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.