WALK-Copenhagen (WALK-Cph): Promoting Physical Activity in Older Adults During Hospitalization and After Discharge
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
研究概览
简要总结
The WALK-Copenhagen project aims at enhancing physical activity during and after hospitalization in older medical patients by an intervention developed in co-operation with key stakeholders
详细描述
In four phases we will develop (Phase 1), fidelity- and feasibility test (Phase 2), efficacy test (Phase 3) and adoption test the intervention (Phase 4). The project will use a combination of qualitative (Phase 1-4) and quantitative methods (Phase 2-3) and consists of two parallel tracks - WALK-Intervention and WALK-Implementation. Phase 1 of the study has been completed. Through workshops with patients, relatives, health professionals and researchers we have developped an intervention to enhance physical activity. Phase 2 will be carried out in October 2018 and January 2019 at Copenhagen University Hospital Hvidovre and in February 2019 at Copenhagen University Hospital, Frederiksberg. The developed intervention will be fidelity tested through daily observations at the wards. Also, the intervention will be feasibility tested in a prospective cohort study aiming at qualifying the intervention, testing recruitment strategies, testing patient willingness towards the intervention, testing randomization and blinding procedures and estimating an inclusion rate for Phase 3 (randomized controlled trial) to be conducted in 2019.
Update March 2019:
Due to a political decision to close down the medical ward at Copenhagen University Hospital, Frederiksberg in the spring of 2019, it was decided to change Phase 3 to a cohort study at Copenhagen University Hospital, Hvidovre. This decision was based on the fact that the methodological setup of the study (cluster RCT) was unintentionally changed due to the close down of one of the intervention wards.
Update November 2019:
Due to changes in characteristics of patients admitted to the intervention ward and thus a very slow inclusion rate in Phase 3 (Cohort Study), it was decided to terminate inclusion of patients. Qualitative data will still be collected as anticipated.
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
- None
盲法说明
All patients at the intervention wards will receive the intervention why neither investigators nor outcome assessors will be blinded to the intervention. Patients at intervention and control wards will get equal information regarding the study and will be asked to participate in equal assessments
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •+65 years
- •acutely admitted to intervention wards
- •able to walk independently with or without walking aid
排除标准
- •in isolation
- •inability to cooperate
- •not able to speak or understand Danish
- •in treatment for cancer
- •terminally ill
- •transferred to intensive care unit or another ward within 24 hours after admission
结局指标
主要结局
Upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor
时间窗: Mean number of hours per day spent upright during hospitalization (up to 7 days)
Between group difference in time spent standing or walking per day (Upright time)
次要结局
- Number of steps measured by an ActivPal (PAL Technologies Ltd) activity monitor(Mean number of steps per day during hospitalization (up to 7 days))
- Change in number of steps measured by an ActivPal (PAL Technologies Ltd)activity monitor(Change in mean number of steps per day between hospitalization and 4 weeks after discharge)
- Time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor(Mean number of hours per day spent lying/sitting during hospitalization (up to 7 days))
- Change in upright time measured by an ActivPal (PAL Technologies Ltd) activity monitor(Change in mean number of hours per day spent upright between hospitalization and 4 weeks after discharge)
- Change in time spent lying/sitting measured by an ActivPal (PAL Technologies Ltd) activity monitor(Change in mean number of hours per day spent lying/sitting between hospitalization and 4 weeks after discharge)
- Change in Life-Space mobility using The University of Alabama at Birmingham (UAB) Life Space Assessment (a 0-120 point scale with 0 representing low mobility and 120 high mobility)(Change in Life Space between admission and 4 weeks after discharge)
- Change in 4-meter gait speed test(Change in habitual gait speed between admission and 4 weeks after discharge)
- Change in mobility using The de Morton Mobility Index (DEMMI) (0-100 point scale with 0 representing low mobility and 100 representing high mobility)(Change in DEMMI score between admission and 4 weeks after discharge)
研究者
Mette Merete Pedersen
Postdoctoral Fellow
Copenhagen University Hospital, Hvidovre