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临床试验/NCT02869854
NCT02869854
已完成
不适用

Increased Adherence to Physical Activity on Prescription (PAP) Through Mindfulness- A Pilot Study.

Region Skane1 个研究点 分布在 1 个国家目标入组 88 人2016年9月30日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Physical Activity
发起方
Region Skane
入组人数
88
试验地点
1
主要终点
Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X)
状态
已完成
最后更新
去年

概览

简要总结

In a pilot study, 90 physically inactive patients will be opportunistically and consecutively recruited and randomized to three intervention groups: mindfulness training, Physical Activity on Prescription (PAP) or only PAP. Follow-up will be done at baseline, three and six months with questionnaires, accelerometers and analysis of traditional risk factors to evaluate whether mindfulness may increase physical activity and decrease physical inactivity.

详细描述

All patients between 40 and 65 years of age who fulfil the inclusion criteria will be asked to participate in the study. Posters with information about the study will be put in the waiting room and in other strategic places. Patients who accept to participate will get written and oral information; they will sign an informed consent after the information. The patients will estimate their level of physical activity in minutes per week to control inclusion criteria. The patients will return in the morning for fasting blood samples and get an accelerometer attached to them to wear for 7 days. During this time, randomization will be performed. They will also get to answer a couple of different surveys. The results from the surveys and blood samples will be the study baseline. All patients with abnormal test results will follow a specific flow diagram for the usual care.

注册库
clinicaltrials.gov
开始日期
2016年9月30日
结束日期
2018年12月18日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Region Skane
责任方
Sponsor

入排标准

入选标准

  • Individuals between 40-65 years of age, with insufficient physical activity ( \<150 minutes of moderate-intensity physical activity throughout the week, or \< 75 minutes of vigorous-intensity physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity.)

排除标准

  • Dementia, severe mental disorder,newly diagnosed untreated unstable angina pectoris,myocardial infarction within 6 weeks prior to study entry. Individuals who do not master the Swedish language in speech and writing will be excluded.The patients who have abnormal values according to guidelines that require contact with a physician on the same day or week will also be excluded

结局指标

主要结局

Difference in Percentage of Time Spent Per Physical Activity Level Per Week of Time, Between the Three Different Groups Measured by Activity Monitor Actigraph (GT3X)

时间窗: Baseline ,6 months.

Each individual will wear an activity monitor for 7 days. This will be done at baseline and after 6 months. The difference in the time of physical activity level was measured in minutes of activity during a week and then divided into percentages of sedentary time, light physical activity time and moderate to vigourous physical activity time, measured by activity monitor Actigraph (GT3X). In the analysis

次要结局

  • Difference Between the Three Groups in Revised Assessment of Their Self-rated Health(base-line ,3 months, 6 months)
  • Difference Between Groups in the Amount of Self-perceived Sleep Problems(Baseline, 3 months, 6 months)

研究点 (1)

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