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临床试验/NCT04042896
NCT04042896已完成不适用

Effects of Exergame vs. Traditional Aerobic Exercise in Patients at High Cardiovascular Risk

Kyoung Im Cho2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Change of volume of maximal oxygen uptake

研究概览

简要总结

Background: Exergaming is thought to have a similar effect on cardiovascular (CV) responses as aerobic fitness activities. The aim of this study was to compare the cardiovascular effects of exergaming and traditional treadmill exercises in patients with high CV risk.

Methods: Sixty-four patients with high CV risk were randomized among exergame (EG: n = 22), treadmill (TM: n = 22), and control (n=20) groups. The EG group was engaged in the running-based exergame using Exer Heart and the TM group walked or jogged on a treadmill. Cardiorespiratory fitness (CRF), brachial artery flow-mediated dilation (FMD), endothelial progenitor cell numbers (EPCs), epicardial fat thickness (EFT), metabolic parameters and anthropometric parameters were measured in patients before and 3 months after the training.

详细描述

Introduction Cardiovascular (CV) disease is a major cause of premature death and morbidity worldwide. It is widely known that age, sex, hypertension, dyslipidemia, diabetes, and smoking are the main risk factors which can cause CV disease[1]. Many other CV risk factors and their markers have been identified in recent studies. Among these, cardiorespiratory fitness (CRF) and endothelial dysfunction are strong predictors of the risk of developing CV disease[2, 3]. In addition, epicardial adipose tissue is a visceral fat which accumulates in the epicardium of the heart, and has recently been considered as a new index of CV risk[4, 5].

It is well established that regular exercise (physical activity) is effective in preventing and treating CV risk factors by improving health-related fitness[6]. Despite the health benefits of regular exercise, many patients with CV risk factors often do not participate in regular exercise for reasons including lack of time, motivation, or interest.

In recent years, a new exercise program called exergame has been developed as a result of the technical advancements in gaming and virtual reality programs. Exergames are interactive video games which provide the opportunity to increase physical activity by requiring movement of the entire body[7] and are proving to be an alternative exercise modality. In addition, exergames are used to fight pediatric obesity[8], improve senior physical performance[9], and facilitate poststroke motor rehabilitation[10]. However, only a few studies have examined the effects of exergaming on CV or chronic disease related risk factors. Furthermore, in order for exergames to progress as a rehabilitation program for the prevention and treatment of CV disease in the future, it is necessary to compare it to traditional aerobic exercises.

Therefore, the aim of this study was to compare the effects of exergame versus treadmill exercises on cardiorespiratory fitness (CRF), endothelial function, epicardial fat, cardiometabolic, and anthropometric parameters in patients with high CV risk.

Methods Participants and Study Design This single-center study was approved by the Institutional Review Board of Kosin University Gospel Hospital (Protocol no. KUGH 2016-06-029). Sixty-four female patients with a Framingham CV disease 10-year risk score above 20% were enrolled in this study[11, 12]. All participants voluntarily participated in the study and signed a consent form agreeing to the study process. In order to reduce the margin of error due to sex differences and physiological responses to the greatest degree possible, only post-menopausal women were recruited considering the hormonal changes which occur during menstruation. The inclusion criteria were post-menopausal women aged ≤80 years who did not have a history of participating in regular exercise within the past 3 months. The exclusion criteria were resistant hypertension, any systemic disease including significant liver disease, neurologic disorders, malignant disease, renal failure, chronic obstructive pulmonary disease, valvular heart disease, a positive treadmill test, a history of acute coronary syndrome, myocardial infarction or any revascularization procedure, or musculoskeletal patients for whom exercise was impossible. Patients were randomized to the exergame (EG: n=22), treadmill (TM: n=22), or control (n=20) groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Framingham CV disease 10-year risk score above 20%
  • post-menopausal women
  • no history of exercise

排除标准

  • resistant hypertension
  • liver disease
  • neurologic disorders
  • malignant disease
  • chronic obstructive pulmonary disease
  • valvular heart disease
  • musculoskeletal patients

研究组 & 干预措施

exergame group

Experimental

The exergame group performed exercise using the Exer Heart device (D&J Humancare, Seoul, South Korea), which consisted of a running/jumping board and a screen connected to the board. The exercise program "Alchemist's Treasure", a running-based exergame, moves the avatar according to the user's motions and was used for the exercise session. "Alchemist's Treasure" is a game in which the user listens to stimulating music, runs with the avatar, avoiding obstacles, and wins items using the front, back, left, and right sensors on the exercise board. The subject can control the speed of the avatar movement by adjusting the walking or running speed on the board.

This study did not enforce exercise intensity in order to allow patients to enjoy the exergame. Thus, during the training period, the patients exercised at a self-selected pace for 40 minutes per day.

干预措施: exergame (Behavioral)

treadmill group

Active Comparator

The treadmill group consisted of 40 minutes of walking or jogging at 60-80% of the heart rate (HR) reserve. The exercise intensity was determined using the Karvonen method target HR = [Exercise Intensity × (HRmax - resting HR)] + resting HR. The HR was recorded during each session using an HR monitor (Polar RS400sd; Madison Height, Michigan, USA). The control group was asked to maintain their regular physical activity level for 12 weeks.

干预措施: treadmill exercise (Behavioral)

control group

No Intervention

The control group was asked to maintain their regular physical activity level for 12 weeks.

结局指标

主要结局

Change of volume of maximal oxygen uptake

时间窗: Change from Baseline maximal oxygen uptake at 3 months

maximal oxygen uptake refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical activity.

次要结局

  • Change of percent of flow mediated dilation(Change from Baseline flow mediated dilation at 3 months)
  • Change of thickness of epicardial adipose tissue(Change from Baseline epicardial adipose tissue at 3 months)

研究者

发起方
Kyoung Im Cho
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Kyoung Im Cho

Clinical Professor

Kosin University Gospel Hospital

研究点 (2)

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