Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay : a Multicenter Randomised Controlled Double Blind Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 4
- 主要终点
- SPPB
研究概览
简要总结
Around 30% of patients aged 65 and over experience functional decline due to hospitalization. Physical inactivity, often without medical justification, is common during hospital stays.This immobility leads to loss of autonomy, muscle strength, and increases post-discharge risks.
Slow walking for 25-40 minutes daily significantly improves functional capacity. However, it could be difficult to reach this time of walking due to a lack of physiotherapist in hospital.
A vibrating watch may encourage patients to walk or perform strengthening exercises. This simple intervention aims to improve function without requiring additional staff or resources
详细描述
30% of patients aged 65 or older will experience a decline in functional capacity as a result of hospitalization.
Illness and hospitalization increase sedentary behavior in patients. It is common for patients to spend long periods of time resting in bed, regardless of their primary reason for admission. During hospitalization, nearly 60% of episodes of bed rest have no documented medical indications. Low physical activity during hospitalization can lead to impaired independence, loss of muscle strength, and decreased functional capacity. These losses in frail individuals are associated with increased disability and lead to a critical 30-day period after hospital discharge that exacerbates deconditioning. This period of increasing functional vulnerability can lead to readmission to hospital, disability, institutionalization, morbidity, and early mortality.
The results of a meta-analysis show that walking slowly for about 25-40 minutes per day is sufficient to improve patients' functional capacity during hospitalization. The organization of care to promote patient mobility must be reviewed to make patients more involved in their care and more independent.
It has been demonstrated for some time that the use of a reminder system (e.g., alarm) is a factor that promotes increased patient adherence to their treatments. The advantage of a vibrating reminder is that it is simple to use, very inexpensive, easy to implement in all hospital wards, and does not require additional human resources.
The main hypothesis of this study is that the use of a vibrating watch set to 6 reminders per day to prompt patients to perform muscle strengthening exercises or walk a distance determined by the rehabilitation professional will increase patients' functional capacity.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 50 or over with a score of 4 or above on the Clinical Frailty Scale (vulnerable but not dependent patients, symptoms limiting activities, patients who are slower/more fatigued).
- •Must be able to get up from a chair without assistance.
- •Patients must be able to communicate with staff, understand instructions, give consent, and cooperate with staff.
排除标准
- •Patients with an estimated hospital stay of less than 5 days.
- •Contraindications to physical activity determined by the medical team (e.g., cardiovascular instability, orthopedic contraindications, etc.).
- •Terminal illness.
- •Patients scheduled for surgery.
- •Pregnant women.
- •People who do not understand French.
- •People protected under the law.
研究组 & 干预措施
Intervention
Regardless of randomization, the physiotherapist will be able to provide the patient with the usual care, such as walking, muscle strengthening exercises, and respiratory physiotherapy if necessary. Self-rehabilitation exercises will be given to the patient, who will have to perform them independently. The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off six times a day. The patient will be required to perform the prescribed exercises each time the vibrating alarm goes off. Six vibrating reminders per day will be sent in the hope that the patient will be active at least three times a day, taking into account various constraints (visits, medical care, examinations, fatigue).
干预措施: Vibrating reminder (Device)
control
In the control group, the physiotherapist will perform the usual treatments and apply the protocol described above in the experimental group, but will set the vibrating watch, to go off once a day. The patient will be advised to perform the exercises every hour independantly.
干预措施: Control group (Device)
结局指标
主要结局
SPPB
时间窗: Within 24 hours of admission and within 48 hours prior to discharge from hospital.
The SPPB (Short Physical Performance Battery) is the sum of scores on three criteria: the balance test, the walking speed test, and the chair rise test. This test assesses an individual's physical performance. The score ranges from 0 (lowest) to 12 (highest). The magnitude of change considered clinically relevant for the SPPB is 1 point.
次要结局
- Volume and intensity of physical activity(Within 24 hours of admission and within 48 hours prior to discharge from hospital.)
- functional independancy(Within 24 hours of admission and within 48 hours prior to discharge from hospital.)
- Patient compliance to the prescribed exercises(Within 24 hours of baseline and within 48 hours prior to discharge from hospital)
- falls(Within 24 hours of baseline and within 48 hours prior to discharge from hospital ; and at 3 months after discharge.)
- Volume and type of rehabilitation in-hospital(Within 24 hours of baseline and within 48 hours prior to discharge from hospital)
- The volume and location of rehabilitation(at 3 months after discharge)
- Health-related Quality of life(24 hours after admission, 48 hours before discharge, and 3 months after hospitalization)