背景:高强度间歇训练(HIIT)已被确定为在多发性硬化症(MS)患者中以有效方式引发促进健康的身体活动的潜在刺激。当前的研究旨在研究使用卧位踏步机(RSTEP)对患有行走障碍的MS患者进行为期12周的HIIT计划的可行性和初始疗效。利益包括过程的可行性结果(即,招募,坚持,和保留率),资源(即,时间和货币成本),管理(即,数据管理和安全报告评估),和科学(即,安全,负担,和治疗效果评估)。我们假设12周的HIIT将通过在过程中满足先验基准是可行的,资源,管理,和科学成果。感兴趣的疗效结果包括有氧健身的变化,身体活动,走路,上臂功能,认知,疲劳,和抑郁症状。我们假设12周的HIIT将导致有氧能力的改善,走路,上臂功能,认知,疲劳,和抑郁症。
方法:采用临床前-后试验设计。参与者(N=16)被招募并参加了12周的RSTEPHIIT计划,他们符合以下纳入标准:年龄≥18岁,自我报告的MS诊断,患者确定的残疾步数量表评分3.0-7.0,过去30天内无复发,愿意去大学实验室学习协议,最大运动测试的无症状状态,医生批准,和自我报告的说话能力,阅读,懂英语.感兴趣的疗效结果的测量包括六分钟步行测试(6MW),定时25英尺行走测试(T25FW),MS中的简要国际认知评估(BICAMS),9孔栓试验(9-HPT),扩展的残疾状态量表(EDSS),疲劳严重程度调查(FSS),医院焦虑和抑郁量表(HADS),戈丁休闲时间锻炼问卷(GLTEQ),多发性硬化步行量表-12(MSWS-12)。参与者完成了分级的最大运动测试,以测量整个干预期间的有氧健身(VO2peak)和运动处方。所有结果均在基线测量,中间点(6周),和干预后(12周)。干预包括12周的监督,使用RSTEP每周两次个性化HIIT会话。单独的HIIT会话包括10个周期的60s间隔,其工作速率与90%VO2peak相关,然后是60s的主动恢复间隔,总共20分钟加上5分钟的热身和冷却时间。Process,资源,管理,并使用描述性统计数据检查科学可行性结果,百分比,和频率分析。使用1因素(时间)评估干预措施的有效性,重复测量方差分析,以确定随时间的显著变化。
结果:在整个研究期间,16名参与者中有14名被保留,对规定锻炼时间的依从性为97%。23名工作人员在两个地点接受了全面培训。仅有一个不良事件报告不影响参与研究,参与者对该计划的总体平均满意度为4.7/5。认知处理速度有统计学意义的变化(p=0.002),GLTEQ(p=0.005),和MSWS-12(p=0.04),但不是健身的其他结果,手臂功能,和走路。值得注意的是,尽管缺乏统计学上的显着变化,但峰值功率输出(d=1.10)和FSS(d=1.05)的效应大小很大。结论:建立了为期12周的个性化RSTEPHIIT计划的可行性,参与者在认知测量方面得到了显着改善。身体活动,和走路。
BACKGROUND: High intensity interval training (HIIT) has been identified as potential stimulus for eliciting health-promoting physical activity in an efficient manner among persons with multiple sclerosis (MS). The current study aimed to examine the feasibility and initial efficacy of a 12-week HIIT program using a recumbent stepper (RSTEP) in persons with MS who have walking disability. Feasibility outcomes of interest included process (i.e., recruitment, adherence, and retention rates), resource (i.e., time and monetary costs), management (i.e., data management and safety reporting assessment), and science (i.e., safety, burden, and treatment effect assessment). We hypothesized that 12-weeks of HIIT will be feasible via meeting a priori benchmarks in process, resource, management, and scientific outcomes. The efficacy outcomes of interest included changes in aerobic fitness, physical activity, walking, upper arm function, cognition, fatigue, and depressive symptoms. We hypothesized that 12 weeks of HIIT would result in improvements in aerobic capacity, walking, upper arm function, cognition, fatigue, and depression.
METHODS: A pre-post clinical trial design was applied. Participants (N = 16) were recruited and enrolled in the 12-week RSTEP HIIT program who met the following inclusion criteria: age ≥18 years, self-reported diagnosis of MS, Patient Determined Disability Steps scale score 3.0-7.0, relapse free in past 30 days, willing to visit a University Laboratory for study protocol, asymptomatic status for maximal exercise testing, physician approval, and a self-reported ability to speak, read, and understand English. Measures of efficacy outcomes of interest included Six Minute Walk Test (6MW), Timed 25 Foot Walk Test (T25FW), the Brief International Cognitive Assessment in MS (BICAMS), 9-hole peg test (9-HPT), Expanded Disability Status Scale (EDSS), Fatigue Severity Survey (FSS), Hospital Anxiety and Depression Scale (HADS), Godin Leisure Time Exercise Questionnaire (GLTEQ), Multiple Sclerosis Walking Scale-12 (MSWS-12). Participants completed a graded maximal exercise test for measuring aerobic fitness (VO2peak) and prescription of exercise throughout the intervention. All outcomes were measured at baseline, mid-point (6-weeks), and post-intervention (12-weeks). The intervention involved 12 weeks of supervised, individualized HIIT sessions two times per week using RSTEP. The individual HIIT sessions included 10 cycles of 60 s intervals at the work rate associated with 90 % VO2peak followed by 60 s of active recovery intervals, totaling 20 minutes plus 5-minute warm-up and cool-down periods. Process, resources, management, and scientific feasibility outcomes were examined using descriptive statistics, percentage, and frequency analyses. The efficacy of the intervention was assessed using a 1-factor (Time), repeated measure analysis of variance to identify significant changes over time.
RESULTS: Fourteen of 16 participants were retained throughout the full study period and adherence with prescribed exercise sessions was 97 %. Twenty-three staff were comprehensively trained across two sites. There was only one adverse event reported that did not impact participation in the study and overall mean satisfaction rating with the program among participants was 4.7/5. There were statistically significant changes in cognitive processing speed (p = 0.002), GLTEQ (p = 0.005), and MSWS-12 (p = 0.04), but not the other outcomes of fitness, arm function, and walking. Of note, there were large effect sizes noted for peak power output (d = 1.10) and FSS (d = 1.05) despite the lack of statistically significant changes CONCLUSION: Feasibility of a 12-week individualized RSTEP HIIT program was established and participants significantly improved on measures of cognition, physical activity, and walking.