Nymberg Peter, Calling Susanna, Stenman Emelie, Palmér Karolina, Hansson Eva Ekvall, Sundquist Kristina, Sundquist Jan, Zöller Bengt
Center for Primary Health Care Research, Region Skåne, Lund, Sweden.
Department of Clinical Sciences, Malmö Lund University, Lund, Sweden.
Pilot Feasibility Stud. 2021 Mar 17;7(1):70. doi: 10.1186/s40814-021-00810-6.
Increased physical activity can have health benefits among inactive individuals. In Sweden, the healthcare system uses physical activity on prescription (PAP) to motivate patients to increase their physical activity level. Mindfulness may further heighten the internal motivation to engage in physical activity. However, previous research has not demonstrated clear evidence of such an association.
Examine the feasibility of the study design as a preparation for a full-scale study, and examine the differences, between three interventions, in change over time in physical activity levels and in related variables.
Comparison between three different interventions in an ordinary primary health care setting: PAP, mindfulness, and a combination of PAP and mindfulness. Physical activity was measured with self-report and ACTi Graph GT1X activity monitor. Statistical analysis was performed with a mixed-effect model to account for repeated observations and estimate differences both within groups and between groups at 3- and 6-months follow-up.
Between September 2016 and December 2018, a total of 88 participants were randomised into three groups. The total dropout rate was 20.4%, the attendance rate to the mindfulness courses (52% > 6 times) and the web-based mindfulness training (8% > 800 min) was low according to the stated feasibility criteria. Eleven participants were excluded from analysis due to low activity monitor wear time. Neither the activity monitor data nor self-reported physical activity showed any significant differences between the groups.
The study design needs adjustment for the mindfulness intervention design before a fully scaled study can be conducted. A combination of PAP and mindfulness may increase physical activity and self-rated health more than PAP or mindfulness alone.
ClinicalTrials.gov, registration number NCT02869854 . Regional Ethical Review Board in Lund registration number 2016/404.
增加身体活动对缺乏运动的个体有益健康。在瑞典，医疗保健系统采用运动处方（PAP）来激励患者提高身体活动水平。正念可能会进一步增强参与体育活动的内在动力。然而，先前的研究尚未证明这种关联的明确证据。
作为全面研究的准备，检验研究设计的可行性，并研究三种干预措施在身体活动水平及相关变量随时间变化方面的差异。
在普通初级卫生保健环境中对三种不同干预措施进行比较：运动处方、正念以及运动处方与正念的组合。通过自我报告和ACTi Graph GT1X活动监测器测量身体活动。采用混合效应模型进行统计分析，以考虑重复观测，并估计在3个月和6个月随访时组内和组间的差异。
2016年9月至2018年12月期间，共有88名参与者被随机分为三组。总退出率为20.4%，根据既定的可行性标准，正念课程的出勤率（52%>6次）和基于网络的正念训练（8%>800分钟）较低。由于活动监测器佩戴时间短，11名参与者被排除在分析之外。活动监测器数据和自我报告的身体活动在各组之间均未显示出任何显著差异。
在进行全面研究之前，研究设计需要针对正念干预设计进行调整。运动处方与正念相结合可能比单独的运动处方或正念更能增加身体活动和自我评定的健康状况。
ClinicalTrials.gov，注册号NCT02869854。隆德地区伦理审查委员会注册号2016/404。
