Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease A Phase 2 Randomized Clinical Trial
Effect of High-Intensity Treadmill Exercise on Motor Symptoms in Patients With De Novo Parkinson Disease A Phase 2 Randomized Clinical Trial
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DOI：
10.1001/jamaneurol.2017.3517
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发表时间：
2018-02-01
期刊：
影响因子：
29
通讯作者：
Corcos, Daniel M.
中科院分区：
文献类型：
--
作者：
Schenkman, Margaret;Moore, Charity G.;Corcos, Daniel M.
帕金森病是一种进行性神经系统疾病。有限的证据表明耐力运动改变了疾病的严重程度，特别是高强度运动。目的检查高强度跑步机运动在没有服用药物的帕金森病患者中的可行性和安全性，以及对运动症状的影响是否需要进行第三阶段试验。设计、设置和参与者帕金森运动疾病研究(SPARX)是一项第二阶段的多中心随机临床试验，有3组和蒙面评估者。来自门诊和社区诊所的个人从2012年5月1日到2015年11月30日登记，主要终点是6个月。特发性帕金森病(Hoehn和Yahr分期1或2)患者，年龄在确诊后5年内40至80岁，每周中等强度运动不超过3次，预计在6个月内不需要多巴胺能药物，参与了这项研究。共有384名志愿者通过电话进行了筛选；128名志愿者被随机分配到3组中的一组(大强度运动、中等强度运动或对照组)。干预：高强度跑步机运动(每周4天，最大心率80%~85%[n=43])、中等强度跑步机运动(每周4天，最大心率60%~65%[n=45])或等待名单对照(n=40)，持续6个月。主要结果和措施可行性措施是坚持每周3天的规定心率和运动频率以及安全性。结果纳入研究的患者共12 8例，平均年龄[9岁；年龄40~80岁；男性73例(57.0%)；非西班牙裔白人108例(84.4%)]。高强度组在80.2%(95%CI，78.8%-81.7%)最大心率下的每周运动率为2.8天(95%CI，78.8%-81.7%；P=.13)，中等强度组在65.9%(95%CI，64.2%-67.7%)最大心率下为3.2天(95%CI，2.8-3.6；P=.13)。高强度组统一帕金森病评定量表运动评分的平均变化为0.3(95%CI，-1.7~2.3)，而常规护理组为3.2(95%CI，1.4~5.1)(P=0.03)。与对照组相比，高强度组，但不是中等强度组，达到了预定的无效阈值。预期的不良肌肉骨骼事件并不严重。结论和相关性高强度跑步机运动对帕金森病患者可能是可行的和安全的处方。有必要进行一项有效性试验，以确定高强度跑步机运动是否对初发帕金森病产生有意义的临床益处。
IMPORTANCE Parkinson disease is a progressive neurologic disorder. Limited evidence suggests endurance exercise modifies disease severity, particularly high-intensity exercise.OBJECTIVES To examine the feasibility and safety of high-intensity treadmill exercise in patients with de novo Parkinson disease who are not taking medication and whether the effect on motor symptoms warrants a phase 3 trial.DESIGN, SETTING, AND PARTICIPANTS The Study in Parkinson Disease of Exercise (SPARX) was a phase 2, multicenter randomized clinical trial with 3 groups and masked assessors. Individuals from outpatient and community-based clinics were enrolled from May 1, 2012, through November 30, 2015, with the primary end point at 6 months. Individuals with idiopathic Parkinson disease (Hoehn and Yahr stages 1 or 2) aged 40 to 80 years within 5 years of diagnosis who were not exercising at moderate intensity greater than 3 times per week and not expected to need dopaminergic medication within 6 months participated in this study. A total of 384 volunteers were screened by telephone; 128 were randomly assigned to 1 of 3 groups (high-intensity exercise, moderate-intensity exercise, or control). INTERVENTIONS High-intensity treadmill exercise (4 days per week, 80%-85% maximum heart rate [n = 43]), moderate-intensity treadmill exercise (4 days per week, 60%-65% maximum heart rate [n = 45]), or wait-list control (n = 40) for 6 months.MAIN OUTCOMES AND MEASURES Feasibility measures were adherence to prescribed heart rate and exercise frequency of 3 days per week and safety. The clinical outcome was 6-month change in Unified Parkinson's Disease Rating Scale motor score.RESULTS A total of 128 patients were included in the study (mean [SD] age, 64 [9] years; age range, 40-80 years; 73 [57.0%] male; and 108 [84.4%] non-Hispanic white). Exercise rates were 2.8 (95% CI, 2.4-3.2) days per week at 80.2%(95% CI, 78.8%-81.7%) maximum heart rate in the high-intensity group and 3.2 (95% CI, 2.8-3.6; P = .13) days per week at 65.9%(95% CI, 64.2%-67.7%) maximum heart rate in the moderate-intensity group (P < .001). The mean change in Unified Parkinson's Disease Rating Scale motor score in the high-intensity group was 0.3 (95% CI, -1.7 to 2.3) compared with 3.2 (95% CI, 1.4 to 5.1) in the usual care group (P = .03). The high-intensity group, but not the moderate-intensity group, reached the predefined nonfutility threshold compared with the control group. Anticipated adverse musculoskeletal events were not severe.CONCLUSIONS AND RELEVANCE High-intensity treadmill exercise may be feasible and prescribed safely for patients with Parkinson disease. An efficacy trial is warranted to determine whether high-intensity treadmill exercise produces meaningful clinical benefits in de novo Parkinson disease.