Physical Exercise and Jaques-Dalcroze Eurhythmics: Effects on Physical and Cognitive Functions, and Falls in Seniors (EPHYCOS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Change in gait variability under dual-task condition
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and the possible mechanisms underlying music-based multitask training (i.e., Jaques-Dalcroze eurhythmics) in older people, compared to multicomponent exercise training.
This study is designed as a 12-month, prospective, single-centre, single-blind, 2-arm, parallel group, randomized controlled trial in which 140 community-dwelling older adults at high risk of falls are randomly assigned to receive either a music-based multitask training intervention (i.e., Jaques-Dalcroze eurhythmics) or a multicomponent exercise training intervention, for 12 months. A 12-month follow-up is planned with outcome measures assessed at three time points: baseline (before intervention initiation), 6-month (intervention mid-point), and 12-month (intervention termination). Outcomes of interest include physical and cognitive performances, and falls. In addition, the investigators specifically address brain circuits in an exploratory sub-study. Volunteer trial participants from both study arms are invited to undergo functional magnetic resonance imaging (fMRI) at baseline and 12-month.
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
- •aged ≥ 65 years (no upper age limit)
- •living in the community, even in protected housing
- •identified as being at high risk of falls (i.e., one or more self-reported falls after the age of 65 years or balance impairment as assessed by a simplified Tinetti test or presence of one or two indicators of physical frailty based on Fried's criteria)
- •willing to comply with all study requirements
排除标准
- •neurological or orthopaedic disease (e.g., stroke with residual motor deficit, Parkinson's disease) with a significant impact on gait and balance performances
- •fully dependent on a technical aid for walking such as canes or walker
- •diagnosis of dementia based on a comprehensive neuropsychological assessment
- •participation in a Jaques-Dalcroze Eurhythmics program or a supervised multicomponent exercise program in the past 12 months
- •serious medical conditions or other factors that may limit adherence to interventions or affect conduct of the trial (e.g., terminal illness)
结局指标
主要结局
Change in gait variability under dual-task condition
时间窗: 6 months, 12 months
次要结局
- Change in balance performances (quantitative balance analysis)(6 months, 12 months)
- Change in functional tests performances (Timed Up & Go test and Short Physical Performance Battery)(6 months, 12 months)
- Change in cognitive performances (comprehensive neuropsychological battery assessing different aspects of executive functioning)(6 months, 12 months)
- Change in anxiety/depression (Hospital Anxiety and Depression scale)(6 months, 12 months)
- Incidence of falls and fractures (prospective daily recording using calendars, to be returned monthly)(6 months, 12 months)
- Change in gait performances (quantitative gait analysis under single and dual-task conditions)(6 months, 12 months)
- Change in fear of falling (Short-FESI)(6 months, 12 months)
研究者
Andrea Trombetti
Principal investigator
University Hospital, Geneva