Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.
DZHK (German Centre for Cardiovascular Research), partner site Greifswald, Greifswald, Germany.
Trials. 2018 Jan 22;19(1):57. doi: 10.1186/s13063-017-2425-2.
Cardiovascular diseases (CVD) are the leading cause of mortality. In 2014, they were responsible for 38.9% of all causes of death in Germany. One major risk factor for CVD is a lack of physical activity (PA). A health-promoting lifestyle including regular PA and minimizing sitting time (ST) in daily life is a central preventive measure. Previous studies have shown that PA decreases in older age; 2.4-29% of the people aged over 60 years achieve the World Health Organization recommendations. This age group spends on average 9.4 h per day in sedentary activities. To increase PA and decrease ST, a low-threshold intervention, consisting of individualized feedback letters based on objectively measured data of PA and ST, was developed. The research question is: Do individual feedback letters, based on accelerometer data, have a positive effect on PA and ST?
METHODS/DESIGN: MOVING is a two-arm, randomized controlled trial. Inclusion criteria are age ≥ 65 years and the ability to be physically active. Exclusion criteria are the permanent use of a wheelchair and simultaneous participation in another study on PA. At baseline participants who give informed consent will receive general information and recommendations about the positive effects of regular PA and less ST. Participants of both groups will receive an accelerometer device, which records PA and ST over a period of seven consecutive days following by a randomization. Participants in the intervention group will receive automatically generated, individualized feedback letters by mail based on their PA and ST at baseline and at 3-month follow-up. Further follow-up examinations will be carried out at 6 and 12 months. The primary outcome is the increase of PA and the reduction of ST after 6 months in the intervention group compared to the control group.
The goal of the study is to examine the effects of a simple feedback intervention on PA and ST in elderly people. We aim to achieve an effect of 20% increase in moderate-to-vigorous physical activity (MVPA). The intervention may have the potential to decrease crucial cardiovascular risk factors and, therefore, contribute to prevention of CVD.
German Clinical Trials Register, ID: DRKS00010410 . Registered on 17 May 2017.
心血管疾病(CVD)是导致死亡的主要原因。2014 年,德国 38.9%的死亡原因是心血管疾病。缺乏身体活动(PA)是 CVD 的一个主要危险因素。促进健康的生活方式包括定期进行身体活动和减少日常生活中的久坐时间(ST),是一种重要的预防措施。先前的研究表明,随着年龄的增长,身体活动量会减少;60 岁以上的人群中有 2.4%-29%的人达到了世界卫生组织的建议。该年龄组每天平均有 9.4 小时处于久坐状态。为了增加身体活动量并减少久坐时间,我们开发了一种基于 PA 和 ST 客观测量数据的个体化反馈信的低门槛干预措施。研究问题是:基于加速度计数据的个体反馈信对 PA 和 ST 是否有积极影响?
方法/设计:MOVING 是一项双臂、随机对照试验。纳入标准为年龄≥65 岁且有能力进行身体活动。排除标准为长期使用轮椅和同时参加另一项关于 PA 的研究。在基线时,知情同意的参与者将获得关于定期进行身体活动和减少久坐时间的积极影响的一般信息和建议。两组参与者都将收到一个加速度计设备,该设备将在连续七天内记录 PA 和 ST,之后进行随机分组。干预组的参与者将通过邮件收到自动生成的、基于其在基线和 3 个月随访时的 PA 和 ST 的个体化反馈信。进一步的随访检查将在 6 个月和 12 个月时进行。主要结局是干预组在 6 个月时与对照组相比 PA 的增加和 ST 的减少。
该研究的目标是检验简单反馈干预对老年人 PA 和 ST 的影响。我们的目标是实现中等到剧烈体力活动(MVPA)增加 20%。该干预措施可能具有降低关键心血管危险因素的潜力,从而有助于预防 CVD。
德国临床试验注册中心,注册号:DRKS00010410。注册于 2017 年 5 月 17 日。