The Transfer Effects of Stationary Bicycle Perturbation Training on Older Adults' Cycling Skills and Behavior (BiPerAge): a Single Blind Randomized Controlled Trial

经常骑自行车促进健康、机动性和自立进入老年。然而，由于与年龄相关的身体功能(协调、平衡控制)的下降，老年人在自行车事故中受伤或死亡的风险显著增加。为了应对这一趋势，迫切需要针对具有挑战性的平衡训练的老年人进行与自行车相关的有针对性的干预--但出于安全原因，到目前为止，在“现实世界”条件下很难做到这一点。最近，以色列项目合作伙伴开发了摄动固定自行车机器人(PerStBiRo)系统，以提供坐着姿势的运动学习和平衡训练。它由安装在移动平台上的一辆固定自行车和一个提供未经宣布的扰动的马达组成。这一创新的系统首次能够模拟在安全条件下(受训者佩戴安全安全带)骑自行车时具有挑战性的平衡丢失情况。为了验证骑自行车干预的转移效果，德国项目合作伙伴建立了一个标准化的自行车课程，展示与交通相关的运动能力(例如左转、上下自行车、转向左侧)。拟议的随机对照试验持续36个月，主要调查PerStBiRo系统的培训是否提高老年人在日常交通情况下的自行车能力。我们的目标是招募127名居住在德国纽伦堡地区(n=70)和以色列比尔舍瓦地区(n=57)的65岁及以上社区居民，他们1)骑自行车时感觉不稳定或在长时间休息后骑自行车，2)客观地测量到骑自行车时的不稳定(≥3自行车赛道表现错误)。参与者将被随机分配到干预组(PerTSBR-有扰动的PerStBiRo系统培训)或积极对照组(TSBR-无扰动的PerStBiRo系统培训)，比例为1：1，按性别和研究中心分层。作为主要结果的自行车能力将在3个月干预期之前(T0)和之后(T1)的标准化自行车课程中进行单盲测试，该干预期包括与日常生活中的交通情况相关的各种运动技能(例如，骑行曲线、装卸、转向左侧)。以周期误差[相对差值(T1-T0)/T0]为因变量，以分组(PerTSBR Vs TSBR)为自变量，经性别和研究中心调整后进行回归分析，以探讨主要目标。此外，我们将在第二层次上探讨PerTSBR训练是否对自行车能力产生长期影响(8个月)，以及心理参数是否受到干预的影响。

Regular cycling promotes health, mobility and independence into old age. However, the risk of older adults being injured or killed in a bicycle accident increases significantly due to the age-related decline of physical function (coordination, balance control). To counteract this trend, targeted cycling-related interventions for older adults with challenging balance training are urgently needed – but so far hardly feasible under “real world” conditions for safety reasons. Recently, the Perturbation Stationary Bicycle Robotics (PerStBiRo) system was developed by the Israeli project partner to provide motor learning and balance training in a seated position. It consists of a stationary bicycle mounted on a moving platform and a motor that provides unannounced perturbations. This innovative system makes it possible for the first time to simulate challenging balance loss situations while cycling under safe conditions (trainees wear a safety harness). To verify the transfer effect of cycling interventions, the German project partner established a standardized cycle course displaying traffic-related motor competences (e.g. turning left, getting on and off the bike, turning to the left side) The proposed randomised controlled trial with a duration of 36 months will primarily investigate whether training on the PerStBiRo system improves the cycling competence of older adults in daily traffic situations. We aim to enroll 127 community-dwelling persons aged 65 years and older living in the area of Nürnberg (Germany, n=70) and in Beer-Sheva region (Israel, n=57) who 1) feel unsteadiness while cycling or uptaking cycling after a long break and 2) have objectively measured unsteadiness while cycling (≥3 errors in cycle course performance). Participants will be randomly assigned to either the intervention group (PerTSBR – training on PerStBiRo system with pertubations) or the active control group (TSBR – training on PerStBiRo system without pertubations) with a ratio of 1:1, stratified by sex and study center. The cycling competence as primary outcome will be tested single blinded in a standardized cycle course prior (T0) and after (T1) the 3 months intervention period, which consists of variant tasks requiring motor skills related to traffic situations in daily life (e.g. riding curves, mounting/dismounting, turning to the left side). To investigate the primary objective, regression analyses with difference of errors in the cycle course [relative difference (T1-T0)/T0] as dependent variable and group (PerTSBR vs TSBR) as independent variable adjusted for sex and study center will be performed. Furthermore, we will explore on a secondary level whether the PerTSBR-training leads to long-term effects (8 months) on cycling competence and whether psychological parameters are affected by the intervention.