The Effect of Accelerometer Guided App Feedback on Change in Activity in Patients With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Average daily activity
研究概览
简要总结
In a cross-over, open-label, randomized, controlled trial, the investigators aim to determine if the daily activity level in patients with LBP can be increased via feedback from an app, connected to a wearable sensor of physical activity.
详细描述
The aim of the study is to determine if a wearable device that measure physical activity and a smartphone application with nudges and feedback increase the physical activity level of patients with low back pain over a 14 days period.
Secondary to determine how many of the patients, that use the smartphone application, and if they perceived the feedback as inspiring.
And to explore, if a potential effect of the device and smartphone application depended on the baseline activity level, gender, diagnoses, age, education level and previous exercise experience.
- Is there a difference in average (mean) daily number of active minutes (defined as walking, cycling, running or exercise) over the 14 days intervention period compared to the 14 days control period.
- If there is an effect of the device and smartphone application, then determine how many of the patients, that use the smartphone application, and if they perceived the feedback as inspiring.
To explore, if a potential effect of the device and smartphone application depended on the baseline activity level, gender, diagnoses, age, education level and previous exercise experience. 3. Is the outcome measures; function measured by sensor, the subjective measurements as pain, stiffness and function, responsive to the intervention compared, to the global scale. 4. Is the patient´s self-evaluated change in activity in the intervention period compared to the baseline period and the control period corelated to the changes in activity measured by the sensor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •non-specific low back pain, spinal stenosis, radiculopathy
- •moderate disability or worse (20-100 points on Oswestry Disability Index)
排除标准
- •co-morbidity making the patients unable to move
- •unsufficient Danish-skills
- •patients who already monitored their activity by watch or phone on a daily basis
- •allergy to band-aid
- •pregnancy or breast-feeding
- •patients referred for back-surgical evaluation
结局指标
主要结局
Average daily activity
时间窗: 1 month
The Primary outcome was defined as the difference in average (mean) daily number of minutes in activity (defined as the sum of time spent with standing, walking, cycling and exercising) in 14 days intervention period compared to 14 days control period, registered by the sensor.
次要结局
未报告次要终点
研究者
Anna Katrine Skovsgaard Itenov
senior registrar, MD
Rigshospitalet, Denmark