Said Catherine M, Morris Meg E, McGinley Jennifer L, Szoeke Cassandra, Workman Barbara, Liew Danny, Hill Keith, Woodward Michael, Wittwer Joanne E, Churilov Leonid, Ventura Cameron, Bernhardt Julie
Department of Physiotherapy, School of Allied Health, La Trobe University, Kingsbury Drive, Bundoora, Victoria, 3086, Australia.
Department of Physiotherapy, Austin Health, 145 Studley Rd, Heidelberg, Victoria, 3084, Australia.
Trials. 2015 Jan 15;16:13. doi: 10.1186/s13063-014-0531-y.
Older adults who have received inpatient rehabilitation often have significant mobility disability at discharge. Physical activity levels in rehabilitation are also low. It is hypothesized that providing increased physical activity to older people receiving hospital-based rehabilitation will lead to better mobility outcomes at discharge.
METHODS/DESIGN: A single blind, parallel-group, multisite randomized controlled trial with blinded assessment of outcome and intention-to-treat analysis. The cost effectiveness of the intervention will also be examined. Older people (age >60 years) undergoing inpatient rehabilitation to improve mobility will be recruited from geriatric rehabilitation units at two Australian hospitals. A computer-generated blocked stratified randomization sequence will be used to assign 198 participants in a 1:1 ratio to either an 'enhanced physical activity' (intervention) group or a 'usual care plus' (control) group for the duration of their inpatient stay. Participants will receive usual care and either spend time each week performing additional physical activities such as standing or walking (intervention group) or performing an equal amount of social activities that have minimal impact on mobility such as card and board games (control group). Self-selected gait speed will be measured using a 6-meter walk test at discharge (primary outcome) and 6 months follow-up (secondary outcome). The study is powered to detect a 0.1 m/sec increase in self-selected gait speed in the intervention group at discharge. Additional measures of mobility (Timed Up and Go, De Morton Mobility Index), function (Functional Independence Measure) and quality of life will be obtained as secondary outcomes at discharge and tertiary outcomes at 6 months follow-up. The trial commenced recruitment on 28 January 2014.
This study will evaluate the efficacy and cost effectiveness of increasing physical activity in older people during inpatient rehabilitation. These results will assist in the development of evidenced-based rehabilitation programs for this population.
Australian New Zealand Clinical Trials Registry ACTRN12613000884707 (Date of registration 08 August 2013); ClinicalTrials.gov Identifier NCT01910740 (Date of registration 22 July 2013).
接受住院康复治疗的老年人在出院时往往存在明显的行动能力障碍。康复期间的身体活动水平也较低。据推测,为接受医院康复治疗的老年人增加身体活动将使出院时的行动能力结果更好。
方法/设计:一项单盲、平行组、多中心随机对照试验,对结果进行盲法评估并采用意向性分析。还将研究干预措施的成本效益。将从澳大利亚两家医院的老年康复科招募60岁以上接受住院康复以改善行动能力的老年人。将使用计算机生成的区组分层随机化序列,以1:1的比例将198名参与者分配到“增强身体活动”(干预)组或“常规护理加”(对照)组,在其住院期间接受相应治疗。参与者将接受常规护理,干预组每周花时间进行额外的身体活动,如站立或行走,对照组则进行等量的对行动能力影响最小的社交活动,如纸牌和棋类游戏。出院时(主要结局)和随访6个月时(次要结局),使用6米步行测试测量自我选择的步速。出院时的其他行动能力指标(起立行走测试、德莫顿行动指数)、功能指标(功能独立性测量)和生活质量指标将作为次要结局,随访6个月时作为三级结局。该试验于2014年1月28日开始招募。
本研究将评估在住院康复期间增加老年人身体活动的疗效和成本效益。这些结果将有助于为该人群制定循证康复计划。
澳大利亚新西兰临床试验注册中心ACTRN12613000884707(注册日期2013年8月8日);美国国立医学图书馆临床试验注册中心标识符NCT01910740(注册日期2013年7月22日)。