A Forced Cycling Exercise Program in Individuals With Parkinson's Disease: Can it Improve Gait Parameters?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 6-minute walk test
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a forced exercise aerobic exercise program, utilizing a cycling activity, on specific gait parameters and balance in individuals with Parkinson's Disease (PD). Design: pilot, feasibility, randomized control, evaluator blinded. Subjects: Twenty four patients with idiopathic PD Hoehn and Yahr (H&Y) stage II or III. Intervention: Participants randomly assigned to one of two exercise groups, forced exercise or self selected exercise, on cycling machine three times a week for 8 weeks. Both groups to exercise at same aerobic intensity level to keep heart rate at 60-80% heart rate max. Outcomes: Gait parameters of step length, width, and variability as measured by the GAITRite; 6 Minute Walk Test; mini-BESTest (balance testing); exercise tolerance via Patient Reported Outcomes Measurement Information System (PROMIS) scale.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants and those performing outcome assessments were not aware of group allotment, nor was the PI. The therapists supervising the exercise interventions were aware of the group allotment
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease
- •Hoehn and Yahr Stages II - III.
- •Ages 30-80 years
- •Medical Clearance
- •Ability to understand and the willingness to sign a written informed consent.
排除标准
- •MOCA: (Montreal Cognition Scale) : rating of less than 24, indicative of cognitive dysfunction
- •Changes in Parkinson's medications within the two weeks prior to starting the study
- •Anticipated change in Parkinson Disease medications during the course of the study
- •Uncontrolled orthostasis
- •Symptomatic coronary artery disease
- •Fracture of lower limb within 6 months prior to study onset or significant lower limb orthopedic diagnosis that would limit cycling
- •Other significant neurologic diagnoses including multiple sclerosis or vestibular disease
- •Acute illness
- •Physical therapy within the month prior to study entry
- •Subjects already participating in a forced exercise or high intensity exercise program
- •Any medical condition that the physician investigator determined would compromise safety.
结局指标
主要结局
6-minute walk test
时间窗: 8 weeks
Distance walked in 6 minutes
次要结局
- miniBESTest (Balance Evaluation Systems Test)(8 weeks)
- Step Width(8 weeks)
- Step variability(8 weeks)
- Stride length(8 weeks)
- 10 meter walk test(8 weeks)
研究者
Christina Marciniak
Professor, Northwestern University and Attending Physician, Shirley Ryan AbilityLab
Shirley Ryan AbilityLab