The Effect of a Smartphone App With Accelerometer on Patients' Physical Activity: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Time spent walking per day (min.)
研究概览
简要总结
The primary objective of this study is to investigate if using Hospital Fit 2.0 as part of the usual care physiotherapy treatment of patients hospitalised at the department of Internal Medicine and the department of Pulmonology in MUMC+ will result in an increase in the amount of PA performed compared to patients who do not use Hospital Fit 2.0 as part of the physiotherapy treatment.
详细描述
Rationale: Low physical activity (PA) levels are common in hospitalised patients. Digital health tools could be valuable to prevent negative effects of inactivity. We therefore developed Hospital Fit 1.0; a smartphone application with accelerometer, designed for hospitalised patients. It enables objective activity monitoring, provides patients insight in their recovery progress and offers a tailored exercise program. Hospital Fit 1.0 has recently been updated, resulting in the improved Hospital Fit 2.0. Improvements in the accelerometer algorithm are made, a goalsetting and reminder function are added, and data from the app can be linked to the electronic medical record. It is hypothesized that using Hospital Fit 2.0 as part of the physiotherapy treatment of hospitalised patients will result in an increase in the amount of PA performed compared to patients who do not use Hospital Fit 2.0 as part of the physiotherapy treatment.
Objective: To investigate if using Hospital Fit 2.0 as part of the usual care physiotherapy treatment will result in an increase in the amount of PA performed compared to patients who did not use Hospital Fit 2.0 as part of the usual care physiotherapy treatment.
Study design: Assessor blinded randomised controlled trial. Study population: 78 patients hospitalised equally distributed over the department of Internal Medicine and the department of Pulmonology at the Maastricht University Medical Center.
Intervention (if applicable): PA will be measured with an accelerometer until discharge with a maximum of seven days in all patients. The control group receives usual care physiotherapy (n=39), while the intervention group uses Hospital Fit additionally (n=39).
Main study parameters/endpoints: Primary outcome parameter: time spent walking per day (min). Secondary outcome parameters: time spent standing per day (min.), average time spent standing and walking (min.) measured over total measurement time (max. 7 days), number of transitions per day and average number of transitions measured over total measurement time (max. 7 days), number of times walking longer than 5 minutes per day and the average number measured over total measurement time (max.7 days), number of times sitting/lying longer than 30 minutes per day and the average number measured over total measurement time (max. 7 days) and the mILAS score per day (max. 7 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigators and outcome assessors are blinded for treatment (control group: usual care physiotherapy treatment versus intervention group: usual care physiotherapy treatment and Hospital Fit 2.0 use)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years
- •Receiving physiotherapy while hospitalised at the department of Internal Medicine department or the department of Pulmonology at the Maastricht University Medical Centre (MUMC+)
- •Sufficient understanding of the Dutch language
- •Having access to a smartphone
- •Able to walk independently 2 weeks before admission, as scored on the Functional Ambulation Categories (FAC >3)
排除标准
- •A contraindication to walking (as reported by the attending medical specialists in the medical record)
- •A contraindication to wearing an accelerometer, fixed by a hypoallergenic plaster at the upper leg (such as active bilateral upper leg infection, severe edema or bilateral transfemoral amputation)
- •Admission at the intensive care department
- •Impaired cognition (delirium / dementia) as reported by the attending doctor
- •Incapacitated subjects as reported by the attending medical specialist in the medical record. When any doubt arises, the patient will not be considered eligible
- •A life expectancy shorter than 3 months as mentioned by the attending medical specialist in the medical record
- •Previous participation in this study
研究组 & 干预措施
Control group
All subjects eligible for inclusion in this study receive usual care physiotherapy as prescribed by the physician. The number of treatment sessions and content of physiotherapy treatment sessions will depend on the diagnosis and needs of the individual patient. This study will not interfere with the content of the usual care physiotherapy treatment. Patients in the control group will receive an accelerometer, measuring PA, which is applied by the physiotherapist during the first treatment. They receive no other additional intervention. Usual care physiotherapy sessions will take approximately 20-30 minutes per session.
Intervention group
Patients in the intervention group will receive usual care physiotherapy and use Hospital Fit 2.0 (HF) additionally. After the last treatment session (max. 7 days), the therapist will remove the accelerometer and participation in the study will end.
干预措施: Hospital Fit 2.0 (Device)
结局指标
主要结局
Time spent walking per day (min.)
时间窗: Period between inclusion and discharge, with a maximum of seven days
Defined as the total number of minutes walking per day.
次要结局
- Number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking) per day(Period between inclusion and discharge, with a maximum of seven days)
- Time spent standing per day (min.)(Period between inclusion and discharge, with a maximum of seven days)
- Average time spent standing(Period between inclusion and discharge, with a maximum of seven days)
- Number of times walking longer than five minutes(Period between inclusion and discharge, with a maximum of seven days)
- Number of times sitting/lying longer than 30 minutes(Period between inclusion and discharge, with a maximum of seven days)
- Average number of times walking longer than 5 minutes(Period between inclusion and discharge, with a maximum of seven days)
- Average number of times sitting/lying longer than 30 minutes(Period between inclusion and discharge, with a maximum of seven days)
- mILAS score per day(Period between inclusion and discharge, with a maximum of seven days)
- Average time spent walking(Period between inclusion and discharge, with a maximum of seven days)
- Average number of transitions from a sedentary position (lying or sitting) to an active position (standing or walking)(Period between inclusion and discharge, with a maximum of seven days)