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临床试验/NCT03169387
NCT03169387Unknown不适用

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

Universidade do Oeste Paulista1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年6月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
24
试验地点
1
主要终点
Change in percentual of body fat

研究概览

简要总结

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%.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

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

研究组 & 干预措施

Virtual Reality

Experimental

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

干预措施: Virtual Reality (Behavioral)

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

干预措施: Conventional Training (Behavioral)

结局指标

主要结局

Change in percentual of body fat

时间窗: Baseline and 8 weeks of training

Body composition

次要结局

  • Change in fat free weight(Baseline and 8 weeks of training)

研究者

发起方
Universidade do Oeste Paulista
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Paula Coelho Figueira Freire

Professor

Universidade do Oeste Paulista

研究点 (1)

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