The HUNT 4 PAI Study: A Randomized Controlled Intervention Study Using Wearable Devices to Promote Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Peak oxygen uptake (VO2peak)
研究概览
简要总结
This study evaluates the effect of a new wearable device, that measures physical activity level based on heart rates, on relevant health outcomes including cardiorespiratory fitness. Half of participants will be instructed in using the Mio Slice wristband, while the other half will be requested to follow today's recommendations for physical activity.
详细描述
Two critical challenges precluding the full potential of physical activity in preventive healthcare are: 1) The majority of people are not sufficiently active, and 2) there is a lack of large, long-term intervention studies documenting the effect of personalized activity and improved health in the population. Using HUNT data an algorithm called Personal Activity Intelligence (PAI) has been developed. PAI was integrated in a smartphone application and user friendly wristband (Mio Slice), that measures heart rate continuously and estimates an individual threshold for total physical activity (defined as 100 weekly PAI) that is associated with reduced risk of cardiovascular disease and mortality. The primary aim of the study is to reveal whether using the wristband will increase cardiorespiratory fitness, determined by maximal oxygen uptake, after 4 months among low-fit participants. The secondary aims includes the effect on reversing cardiovascular risk factors, cardiac structure and function, adherence to physical activity and identification of barriers after 16 weeks and 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 23 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participated in HUNT 3 and HUNT 4 Fitness Study
- •VO2peak in HUNT4 in the lowest sex- and age-specific tertile.
排除标准
- •Illness or disabilities that preclude completion of the study or make exercise contraindicated
- •uncontrolled hypertension, arrhythmias or angina
- •heart failure
- •primary pulmonary hypertension
- •diagnosed dementia
- •chronic communicable infectious diseases
- •participation in conflicting interventions
研究组 & 干预措施
PAI group
Participants randomized to the PAI-group will receive a wearable device (Mio Slice PAI wristband) that measure heart rate continuously and via an algorithm calculates a physical activity score called PAI. The weekly goal of 100 PAI can be reached by a combination of different intensities and durations and the participants will get continuous information about their current score and amount of activity needed to reach the goal. 100 PAI is expected to approximate current guidelines of 150 minutes of moderate intensity or 75 minutes of vigorous intensity for the average participant or somewhat less if the intensity of the chosen activity is high. Proper instruction in use of the device and App will be given both oral and written after baseline testing and randomization.
干预措施: PAI group (Behavioral)
PAI group
Participants randomized to the PAI-group will receive a wearable device (Mio Slice PAI wristband) that measure heart rate continuously and via an algorithm calculates a physical activity score called PAI. The weekly goal of 100 PAI can be reached by a combination of different intensities and durations and the participants will get continuous information about their current score and amount of activity needed to reach the goal. 100 PAI is expected to approximate current guidelines of 150 minutes of moderate intensity or 75 minutes of vigorous intensity for the average participant or somewhat less if the intensity of the chosen activity is high. Proper instruction in use of the device and App will be given both oral and written after baseline testing and randomization.
干预措施: Usual care (Behavioral)
Usual care
Usual care: Participants in the control group will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Peak oxygen uptake (VO2peak)
时间窗: 16 weeks
Measured by ergospirometry during a maximal treadmill protocol to exhaustion
次要结局
- Quality of life(1 year)
- Peak oxygen uptake (VO2peak)(1 year)
- Cardiovascular risk profile (ESC Score)(1 year)
- Structural and functional cardiac changes(1 year)
- Adherence to prescribed physical activity(1 year)
- Feedback from users(1 year)