Mobile Exergaming for Health - Effects of a Serious Game Application for Smartphones on Physical Activity and Exercise Adherence in Type 2 Diabetes Mellitus (Randomized Controlled Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline daily physical activity at 24 weeks
研究概览
简要总结
The purpose of this study is to investigate if MOBIGAME (an innovative, mobile phone-based game application) is suitable to increase daily physical activity and physical activity adherence as well as health parameters such as cardiorespiratory fitness, leg strength, glucose metabolism, vascular health and self-determination as well as health related quality of life in the course of a 24-week intervention in comparison to the control group receiving one-time lifestyle counseling.
详细描述
In recent years, type 2 diabetes mellitus (T2DM) has grown into an emerging pandemic that is a key determinant of morbidity and mortality in both developed and developing countries worldwide. The successful treatment and prevention of T2DM is one of the biggest future health care challenges and most important to manage the enormous socio-economic burden that is associated with T2DM and its various comorbidities. Physical inactivity is known to be one of the most important risk factors for the development of obesity and T2DM. In contrast, increases in physical activity (PA) and fitness can lower the T2DM incidence, improve the patient's glucose metabolism and reduce morbidity and (premature) mortality, independent of body mass index (BMI) or other risk factors. Despite the obvious benefits of regular PA in the treatment and prevention of T2DM, most activity-promoting programs targeting T2DM patients are seldom successful in the long term due to diminishing patient motivation. A novel approach to motivate those individuals that are the least likely to engage in regular PA to be more physically active and adhere to regular PA are active video games or "exergames" that combine PA and video gaming. However, existing exergames do not offer fitness-level adjusted, individualized workouts and are normally stationary and bound to a TV, thus not enabling PA anywhere and at any time. To address these shortcomings, the investigators used sports scientific expertise to develop a smartphone-based, mobile gardening simulation game application, specifically designed for middle-aged T2DM patients, to induce a healthier, more active lifestyle as part of a successful T2DM treatment and management.
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 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •Non-insulin-dependent diabetes mellitus (doctor diagnosed)
- •Body Mass Index >25 kg/m2
- •Regular smartphone use during the last year before the study
- •Motivation to participate in the study for its entire duration of 24 weeks
排除标准
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Previous enrolment into the current study
- •Participation in other studies in the last four weeks
- •Systolic blood pressure > 170mmHg, diastolic blood pressure > 100 mmHg
- •Regular physical activity before the study (≥150 min moderate intensity daily PA per week or >1 endurance or strength training session per week of more than 30 min in duration)
研究组 & 干预措施
Intervention
MOBIGAME group
干预措施: MOBIGAME (Device)
Control
Lifestyle counseling group
干预措施: Control (Other)
结局指标
主要结局
Change from baseline daily physical activity at 24 weeks
时间窗: Baseline and 24 weeks
Measured as steps per day.
次要结局
- Adherence to the intervention(24 weeks)
研究者
Arno Schmidt-Trucksäss
Prof. Arno Schmidt-Trucksäss MD, MA, FESC
University of Basel
