Department of Physical Medicine and Rehabilitation, College of Physicians and Surgeons, Columbia University Medical Center, Harkness Pavilion, 180 Fort Washington, New York, NY, 10032, USA.
Department of Neurology, College of Physicians and Surgeons, Columbia University Medical Center, New York, NY, USA.
Cerebellum. 2023 Apr;22(2):272-281. doi: 10.1007/s12311-022-01394-4. Epub 2022 Mar 18.
Balance training has shown some benefits in cerebellar ataxia whereas the effects of aerobic training are relatively unknown. To determine whether a phase III trial comparing home aerobic to balance training in ambulatory patients with cerebellar ataxia is warranted, we conducted a single-center, assessor-blinded, randomized controlled trial. Nineteen subjects were randomized to aerobic training and 17 subjects to balance training. The primary outcome was improvement in ataxia as measured by the Scale for the Assessment and Rating of Ataxia (SARA). Secondary outcomes included safety, training adherence, and balance improvements. There were no differences between groups at baseline. Thirty-one participants completed the trial, and there were no training-related serious adverse events. Compliance to training was over 70%. There was a mean improvement in ataxia symptoms of 1.9 SARA points (SD 1.62) in the aerobic group compared to an improvement of 0.6 points (SD 1.34) in the balance group. Although two measures of balance were equivocal between groups, one measure of balance showed greater improvement with balance training compared to aerobic training. In conclusion, this 6-month trial comparing home aerobic versus balance training in cerebellar ataxia had excellent retention and adherence to training. There were no serious adverse events, and training was not interrupted by minor adverse events like falls or back pain. There was a significant improvement in ataxia symptoms with home aerobic training compared to balance training, and a phase III trial is warranted. Clinical trial registration number: NCT03701776 on October 8, 2018.
平衡训练已显示出对小脑性共济失调的一些益处,而有氧训练的效果则相对未知。为了确定是否需要进行一项比较家庭有氧训练与平衡训练对小脑性共济失调患者的 III 期试验,我们进行了一项单中心、评估者盲法、随机对照试验。19 名受试者被随机分配到有氧训练组,17 名受试者被分配到平衡训练组。主要结局是通过共济失调评估量表(SARA)测量的共济失调改善。次要结局包括安全性、训练依从性和平衡改善。两组在基线时无差异。31 名参与者完成了试验,没有与训练相关的严重不良事件。训练依从性超过 70%。有氧训练组的共济失调症状平均改善 1.9 个 SARA 点(SD 1.62),而平衡训练组的改善为 0.6 个 SARA 点(SD 1.34)。尽管两组间有两项平衡措施存在争议,但一项平衡措施显示平衡训练比有氧训练有更大的改善。总之,这项比较小脑性共济失调家庭有氧与平衡训练的 6 个月试验保留率和训练依从性都很好。没有严重的不良事件,训练也没有因跌倒或背痛等轻微不良事件而中断。与平衡训练相比,家庭有氧训练可显著改善共济失调症状,因此需要进行 III 期试验。临床试验注册号:NCT03701776,于 2018 年 10 月 8 日注册。