Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]
研究概览
简要总结
Forced cadence cycling (FCC) in which individuals with Parkinson's Disease (PD) pedal with external augmentation at 80-90 revolutions per minute (rpm) has demonstrated significant motor improvement in prior clinical trials. These studies required either a tandem bicycle with second rider or an expensive motorized bicycle, making this therapy inaccessible to most patients. In this pragmatic open-label before and after pilot study investigators examine implementation and effectiveness of (RCC) without tandem or motor augmentation and in a community-based setting. Approximately 30 participants will be recruited to participate in 24 one-hour rapid-cadence spin classes in YMCAs over 8 weeks. Primary outcomes will examine implementation of the intervention and secondary outcomes will examine effectiveness against a historical comparison group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 or older.
- •Clinically confirmed diagnosis of idiopathic PD by a movement disorder specialist.
- •Hoehn and Yahr stage I-III while ON anti-parkinsonian medication.
- •Stable or absent MAO-B inhibitors (Selegiline, Rasagiline, Zydis selegiline HCL Oral disintegrating) for at least 60 days prior to enrollment; stable or absent other medications for PD motor symptoms (Levodopa, Dopamine agonists, Anticholinergics, Amantadine, COMT-Inhibitors) for at least 30 days prior to enrollment; stable or absent medications for the following PD-non-motor symptoms: depression, anxiety, cognition, sleep, orthostatic hypotension.
- •Agreement to defer any medication changes until after completion of 8-week program and post-test measurements.
- •Written permission by a physician to participate in the program.
- •English language proficiency sufficient to understand and participate in a cycling class taught in English.
排除标准
- •Clinically significant medical disease that would increase the risk of exercise-related complications (eg: cardiac or pulmonary disease, uncontrolled diabetes mellitus, uncontrolled hypertension or stroke) as determined by a treating physician through letter obtained by YMCA or the study investigator.
- •Dementia as evidenced by a score of less than 116 on the Mattis Dementia Rating Scale or dementia in the opinion of the study investigator that would prohibit subject from complying with all study activities.
- •Other medical or musculoskeletal contraindication to exercise.
- •Concurrent participation in another trial of exercise therapy for PD or initiation of a new structured exercise plan during the duration of the study. Note: participants may continue any pre-existing exercise routine (including group-based classes) during the study but will be asked not to start anything new.
结局指标
主要结局
Percentage of individuals who complete at least 80% of offered cycling sessions [Tolerability]
时间窗: assessed at conclusion of the 8 week intervention
Investigators will consider those who do not withdraw from the study, are not lost to follow up, and complete at least 80% of the cycling sessions to demonstrate tolerability of the study.
Proportion of subjects reporting an adverse event during class [Safety]
时间窗: assessed at each class by study staff and weekly by PI for duration of 8 week intervention
Safety will be reported descriptively and include the proportion of subjects reporting any adverse event.
次要结局
- Modified Unified Parkinson's Disease Rating Scale-section III Motor(Assessed within two weeks prior to start of intervention and within one week after completion of intervention)
- Assessment of Intelligibility of Dysarthria (AIDS)(Assessed within two weeks prior to start of intervention and within one week after completion of intervention)
- Timed Up and Go(Assessed within two weeks prior to start of intervention and within one week after completion of intervention)
- Trail Making Test A& B(Assessed within two weeks prior to start of intervention and within one week after completion of intervention)
- PROMIS sf v1.0 Global Health(Assessed within two weeks prior to start of intervention and within one week after completion of intervention)
研究者
Anne-Marie Alexandra Wills, MD
Assistant Professor in Neurology
Massachusetts General Hospital