In-hospital and Post-discharge Training of Older Medical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Mobility using the de Morton Mobility Index (DEMMI)
研究概览
简要总结
The project aims to investigate the clinical value of simple strength training during hospitalization and after discharge as part of an enhanced recovery programme for acutely admitted older medical patients, in order to prevent mobility decline following acute hospitalization.
Note 11/23/16: As noted in the protocol (doi: 10.1186/s13063-016-1309-1) we have obtained funding and ethical approval (H-2-2012-115/09-12-2016) to extend the study to achieve sufficient power to look more deeply into our secondary outcomes. This will constitute a secondary part of the trial (started Nov. 2016). The primary trial report will include data for the pre-specified sample size for which the last patient was assessed Oct. 2016. Hence, the primary completion date for part 1 was April 2016 and the study completion date for part 1 was Oct 2016. The trial status is still "recruiting" although this applies to part 2 of the study.
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
- Single (Outcomes Assessor)
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 of age
- •admitted from own home
排除标准
- •Terminal illness
- •In treatment for diagnosed cancer
- •Assigned to physical rehabilitation in community
- •Chronic Obstructive Pulmonary Disease (COPD) patients participating in organized rehabilitation
- •Living outside of the municipalities of Copenhagen and Broendby
- •Not able to talk and understand danish
- •Not able to cooperate on tests/exercises
- •Hospitalized < 24 hours
- •A Cumulated Ambulation Score (CAS) of 0 in the sit-to-stand item
研究组 & 干预措施
Strength training
Supervised strength training daily during hospitalization and 3 times per week for 4 weeks after discharge in the participant's home
干预措施: Strength training (Other)
Usual care
Usual care
结局指标
主要结局
Mobility using the de Morton Mobility Index (DEMMI)
时间窗: Admittance (baseline), discharge, 4 weeks after discharge (primary analysis), and 26 weeks after discharge
The DEMMI is an advanced instrument for accurately measuring the mobility of older people across clinical settings (www.demmi.org.au). The primary analysis for the primary outcome is the change in the DEMMI score from baseline to the assessment 4 weeks after discharge (end of intervention). The primary analysis will follow the intention-to-treat principle (last observation carried forward) and be unadjusted in order to determine a systematic group-difference in the change from baseline to 4 weeks post discharge (end of training) for the primary outcome.
次要结局
- Hand-grip strength of dominant hand(Admittance (baseline), discharge, 4 weeks post discharge and 26 weeks post discharge)
- 30-sec sit to stand test(Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge)
- 24-hour mobility(Admittance to discharge, discharge to 1 week post discharge, 4 weeks post discharge to 5 weeks post discharge, 26 weeks post discharge to 27 weeks post discharge (4 x 1 week))
- Isometric knee-extension strength in dominant leg(At admittance (baseline), at discharge, 4 weeks after discharge and 26 weeks after discharge)
- Habitual gait speed(Admittance (baseline), discharge, 4 weeks post discharge, 26 weeks post discharge)
研究者
Mette Merete Pedersen
PhD student
Copenhagen University Hospital, Hvidovre