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临床试验/NCT02657018
NCT02657018已完成不适用

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)

University of Basel2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
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

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

Experimental

MOBIGAME group

干预措施: MOBIGAME (Device)

Control

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arno Schmidt-Trucksäss

Prof. Arno Schmidt-Trucksäss MD, MA, FESC

University of Basel

研究点 (2)

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