Body Composition of Individuals With Cardiovascular Diseases

NCT03169387 | Unknown DMC

• 1 other identifier: 35632017
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 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%.

Conditions

Cardiovascular Diseases; Body Composition

Keywords

Virtual Reality Exposure Therapy

Outcome Measures

Primary Outcomes (1)

• Change in percentual of body fat

  Body composition

  Baseline and 8 weeks of training

Secondary Outcomes (1)

• Change in fat free weight

  Baseline and 8 weeks of training

Other Outcomes (1)

• Change in abdominal circumference

  Baseline and 8 weeks of training

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Microsoft's Xbox 360® will be used with Kinect™,

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

Behavioral: Conventional Training

Interventions

Virtual Reality BEHAVIORAL

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.

Also known as: Experimental: Virtual Reality

Virtual Reality

Conventional Training BEHAVIORAL

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.

Also known as: Active Comparator: Conventional Training

Conventional Training

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade do Oeste Paulista: lead

Study Sites (1)

Ana Paula Coelho Figueira Freire

Presidente Prudente, São Paulo, 19050070, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

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

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 30, 2017
• Study Start: June 30, 2017
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)