Effects of Aerobic Exercise in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Change in Aerobic Fitness
研究概览
简要总结
Motivated by reported improvements in aerobic fitness and executive functions after a 6-month aerobic walking intervention in normal sedentary elderly, we conducted a Phase I/II study to investigate effects of aerobic exercise on motor function, cognition, and quality of life in mild-moderate patients with Parkinson's disease (PD). To identify the best method to deliver fitness training, we also aimed to compare safety, tolerability, and fitness benefits between different training methods (continuous/moderate intensity vs. interval/alternating between low and vigorous intensity) and exercise settings (individual vs. group). Interval training reportedly facilitates higher fitness gains than continuous training. Group training may promote success through social interaction, whereas individual training offers greater flexibility.
Details of the study can be found in the publication below:
Phase I/II randomized trial of aerobic exercise in Parkinson disease in a community setting.
Uc EY, Doerschug KC, Magnotta V, Dawson JD, Thomsen TR, Kline JN, Rizzo M, Newman SR, Mehta S, Grabowski TJ, Bruss J, Blanchette DR, Anderson SW, Voss MW, Kramer AF, Darling WG.
Neurology. 2014 Jul 29;83(5):413-25. doi: 10.1212/WNL.0000000000000644. Epub 2014 Jul 2.
PMID: 24991037
详细描述
Participants:
The participants were recruited in Spring 2009, 2010, and 2011 through regional newspaper advertisements and solicitations in the Movement Disorders Clinic at the University of Iowa and the Veterans Affairs Medical Center of Iowa City. We phone screened respondents and evaluated eligible candidates in-person using clinical examination, MMSE, 12-lead ECG, blood count and biochemistry, followed by graded exercise test using cycle ergometry within one week of starting the intervention. At each visit, we obtained body weight and height, heart rate and blood pressure after 5 minutes of supine rest [Goldberg et al. 1988] and after 3 minutes of standing. Throughout the study, the medications of participants continued to be managed by their treating neurologists.
Inclusion criteria: Idiopathic PD; Hoehn and Yahr Scale I-III; men or women aged 50-80; stable dopaminergic treatment regimen for at least 4 weeks prior to baseline not requiring adjustment.
Exclusion criteria: Current participation in an aerobic exercise program; Mini Mental Status Exam score <24; confounding medical, orthopedic or psychiatric disorders; cardiac abnormalities during cycle ergometry.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran or non-veteran;
- •Presence of all 3 cardinal features of Parkinson's disease (resting tremor, bradykinesia, and rigidity), which have to be asymmetrical;
- •Hoehn and Yahr Scale stage I-III;
- •Men or women aged 50-80 capable of performing the planned exercise programs;
- •Intention to remain in the local area over the study period;
- •Stable dopaminergic treatment regimen for at least 4 weeks prior to baseline without any clinical need for medication adjustment at the time of screening
排除标准
- •Secondary parkinsonism;
- •Parkinson-plus syndromes;
- •MMSE score <24;
- •Participating in a aerobic exercise program;
- •An unstable dosage of drugs active in the central nervous system (e.g., anxiolytics, antidepressants) during the 60 days before the baseline visit;
- •Participation in drug studies or the use of investigational drugs within 30 days before screening; structural brain disease;
- •Active epilepsy;
- •Acute illness or active, confounding medical, neurological, or musculoskeletal conditions; alcoholism or other forms of drug addiction;
- •Inability to complete the graded exercise test;
- •Lack of medical clearance from our pulmonologist;
- •Intention to move or take a >1 month vacation during the study period;
- •Contraindications to MRI or claustrophobia requiring sedation
研究组 & 干预措施
Continuous training
Aerobic walking using continuous heart rate training.
干预措施: Continuous training (Behavioral)
Interval training
Aerobic walking using interval heart rate training
干预措施: Interval training (Behavioral)
结局指标
主要结局
Change in Aerobic Fitness
时间窗: 6 months
VO2max after the training - VO2max at baseline (Adjusted for levodopa-equivalent, year, training mode, setting). Please see publication PMID: 24991037 for details.
次要结局
- Change in the MOCA Score(6 months)
- Change in the UPDRS Section III Score(6 months)
- Change in 7 Meter Walk Time(6 months)
- Change in the UPDRS Section I Score(6 months)
- Change in UPDRS Section II Score(6 months)
- Change in the Total UPDRS Score(6 months)
- Change in Percent Increase Score (PIS) on Eriksen's Flanker Task(6 months)