Effect of Rhythm-based Multitask Training on Fall Rate in Community-dwelling Older Adults: An Assessor-blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Fall rate (falls per person-years)
研究概览
简要总结
In this assessor-blinded, randomized, controlled trial our primary aim is to quantify the effects of a six-month rhythm-based multitask training (RYMA) intervention on fall rates collected over 12 months, compared to continuation of regular activity schedule, among community-dwelling older adults (≥70 years).
This assessor-blinded, randomized, controlled trial aim is to quantify the effects of six-month rhythm-based multitask training (RYMA) on fall rates collected over 12 months, compared to continuation of regular activity schedule, among community-dwelling older adults (≥70 years).
A sample size calculation estimates that 126 older community-dwelling older adults (≥70 years) are needed. Following baseline measures, the recruited participants will randomly be assigned to either the RYMA or the control group. The participants in the RYMA group will be assigned to a single weekly one-hour session for six months, while the control group will be encouraged to continue their regular activity schedule. Assessment of the primary outcome, fall rates, will be conducted continuously in 12 months from the beginning of training using monthly fall calendars. When a fall is reported in the fall calendar, a telephone interview will be conducted to assess circumstances and consequences (e.g. fall-related fractures, fall-related hospital admissions) of the falls. Moreover, assessment of physical, cognitive, and social-psychological surrogate outcomes will be made at baseline, six, and 12 months.
详细描述
Background:
Approximately one-third of older adults (≥65 years) fall at least once a year and 40-60% of falls lead to injuries. Of these injuries, 30-40% are minor, such as brushes, while 10% are serious, such as head injuries or fractures. Indeed, falls are the most common cause of injuries among older adults, and injuries are the fifth leading cause of premature death among older adults.
In an attempt to reduce the fall rate, several fall prevention interventions have been examined. Here, physical exercise has proven as an effective and cost-effective approach. However, the majority of exercise interventions only addressed physical risk factors while only a few focused on cognitive risk factors. For instance, a reduced executive function has been associated with increased fall risk. Thus, interventions addressing both physical and cognitive functions could enhance the efficacy of fall prevention.
Cognitive-motor training is a training modality that simultaneously incorporates physical and cognitive elements. A cognitive-motor training approach is RhYthm-based Multitask trAining (RYMA). During RYMA, participants perform rhythm-based balance-challenging multitask exercises following the rhythm of improvised piano music. A preliminary study by Trombetti et al. 2011 showed promising results as the fall rate decreased by 54% following six months of RYMA using a Dalcroze Eurhythmics approach compared to controls. The observed reduced fall rate may be due to RYMAs ability to decrease gait variability under dual-task conditions, improve postural balance, and executive function. However, the Trombetti study had some limitations. For instance, the primary outcome was gait-variability and not fall rates. Thus, the study was not adequately designed to quantify differences in fall rates (e.g. no follow-up period with a no-attention control group). Moreover, the effects of RYMA on social-psychological factors, such as health-related quality of life (HRQoL), fear of falling, and loneliness is yet be investigated.
Methods:
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
- Single (Outcomes Assessor)
盲法说明
The randomization will be conducted by staff members not involved in the data collection. Moreover, the randomization code will only be available for non-blinded research staff to maintain allocation concealment.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥70 years old
- •Community-dwelling
- •Able to walk 20 meters without a walking aid
- •Understand and remember a message in Danish
- •Willing to provide informed consent for the trial
排除标准
- •Having a progressive neurological disease (e.g. Parkinson, multiple sclerosis, etc.)
- •Unstable medical conditions that would prevent safe participation
- •Severe cognitive impairment
- •Current participation in another fall prevention trial
结局指标
主要结局
Fall rate (falls per person-years)
时间窗: 12 months following the randomization
Fall calendar
次要结局
- Number of falls, number of fallers/non-/multiple-fallers, and time to first fall(12 months following the randomization)
- Single- and dual-task gait(Baseline, six months, and 12 months)
- Number of fall-related injuries(12 months following the randomization)
- Number of fall-related hospital admissions(12 months following the randomization)
- Single- and dual-task balance(Baseline, six months, and 12 months)
- Health-related quality of life(Baseline, six months, 12 months, and during phone-interview following a registered fall)
- Executive function(Baseline, six months, and 12 months)
- Choice stepping reaction time(Baseline, six months, and 12 months)
- Lower extremity physical performance(Baseline, six months, and 12 months)
- Fear of Falling(Baseline, six months, and 12 months)
- Loneliness(Baseline, six months, and 12 months)
- Frailty(Baseline and 12 months)
研究者
Jens Eg Nørgaard
PhD-student, Cand.Scient.
Aalborg University Hospital