Training at the Limit of Balance Control on a Perturbation Treadmill to Prevent Unrecovered Falls in Geriatric Patients With and Without Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 396
- 试验地点
- 6
- 主要终点
- Rate of unrecovered falls
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of perturbation-based balance training (PBT) in preventing unrecovered falls among geriatric patients aged ≥70 years with a prospective fall risk of ≥40%. The study will also assess the safety and feasibility of PBT. The main research questions are:
A total of 396 participants will receive 9 training sessions of either PBT or conventional treadmill training and will attend an assessment before and after the intervention, as well as 6 and 12 months follow up. Falls will be documented throughout the entire study period using calendars, telephone interviews, and proxy information. The primary outcome, unrecovered falls, will be recorded after the end of the intervention until 12 months follow up.
详细描述
Falls are common and the leading cause of injuries among older adults, but falls may be attenuated by the promising and time-efficient intervention called perturbation-based balance training (PBT). The aim of the TRAIL-study is to confirm the effectiveness of a treadmill PBT protocol for preventing unrecovered falls in geriatric patients with and without cognitive impairment. This study is designed as a confirmatory, multicenter, assessor-blinded, randomized controlled study. The 396 geriatric patients aged ≥70 years with ≥40% prospective fall risk and being capable of walking ≥70 m in a 2-Minute Walk Test will receive 9 sessions of PBT on a treadmill (intervention) or a conventional treadmill training (control group; CTT).
Outcome assessments will be performed shortly after the intervention interval as well as 6 and 12 months thereafter. The primary outcome is defined as unrecovered falls (defined as falls in which persons who fell are unable to get up independently) within 12-month follow-up. Falls are documented over at least 12 months using calendars, telephone interviews, and proxy information. Secondary outcomes include mobility, balance performance, concerns about falling, physical activity and capacity, stepping responses, health-related quality of life, cognitive functioning, mobility, reactive dynamic balance and training acceptability of PBT. The study will be accompanied by a patient advisory board and an expert advisory board and focus groups will be conducted to involve the target group.
Based on pilot studies and the available literature, we expect a ≥50% reduction of unrecovered falls during the following year in the intervention group (PBT) compared to the control group (CTT).
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)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 70 years
- •≥40% prospective fall risk for the following year according to the Fall Risk Assessment Tool (FRAT-up)
- •Walking distance ≥ 70 m in the 2 Minute Walk Test
- •Possibility to reach the study site at least via taxi
- •Written informed consent, obtained according to international guidelines and local laws
排除标准
- •MoCA score < 10 pts (or MMSE < 17 pts)
- •Performing a Timed up and Go test (TUG) <10 s
- •Leg amputation
- •Osteosynthesis or joint replacement of lower extremities within the past 6 weeks.
- •Blindness
- •Parkinson's disease with Hoehn and Yahr stage > 3
- •Body weight >135 kg and height >185 cm
- •Life-expectancy <12 months, instable or severe illness
- •Inability to communicate verbally and coorporate appropriatly
- •(Prior) participation perturbation training programs
- •Gait-relevant foot-drop paresis
结局指标
主要结局
Rate of unrecovered falls
时间窗: Continuously from intervention end until 12 months after the end of the intervention
Falls are assessed using fall calendars, telephone interviews, and proxy information.
次要结局
- Rate of falls(Continuously from intervention end until 12 months after the end of the intervention)
- Physical activity(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Stepping response (a)(12 months after the intervention)
- Stepping reponse (b)(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Cognitive functioning (a)(Before the training intervention (up to 4 weeks before the beginning of the training), and 12 months after the intervention)
- Cognitive functioning (b)(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Concerns about falling(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Health-related quality of life(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Physical capacity (a)(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Physical capacity (b)(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Physical capacity (c)(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
- Nutritional status(Before the training intervention (up to 4 weeks before the beginning of the training), 6 months after the intervention, and 12 months after the intervention)
- Reactive dynamic balance (a)(3rd (during the on average 1st week of the intervention) and last training session (during the on average 3rd week, at maximum 6th week of the intervention) (intervention group only), and 12 months after the intervention (intervention and control group))
- Reactive dynamic balance (b)(3rd (during the on average 1st week of the intervention) and last training session (during the on average 3rd week, at maximum 6th week of the intervention) (intervention group only), and 12 months after the intervention (intervention and control group))
- Laboratory falls(during 3rd (on average 1st week of the intervention) and last training session (on average 3rd week, at maximum 6th week of the intervention; intervention group only), and 12 months after the intervention (intervention and control group))
- Acceptability of PBT(during the last training session (during the on average 3rd week, at maximum 6th week of the intervention, in the intervention group only))
- Vibration sensation(Before the training intervention (up to 4 weeks before the beginning of the training), after the intervention (up to 8 weeks after its beginning), 6 months after the intervention, and 12 months after the intervention)
研究者
Prof. Dr. med. Tania Zieschang
Prof. Dr. med.
University of Oldenburg