The Effects of a High Intensity Exercise Training Program on Sleep and Vigilance in Patients With Parkinson's Disease (The Effect of Low Frequency STN DBS on Sleep and Vigilance in PD Patients)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Motor outcome measured by Timed up and go test (TUG)
研究概览
简要总结
The purpose of this randomized, controlled interventional study is to determine the effects of a high intensity exercise training program on objective sleep measures, daytime sleepiness, mobility, and brain health/functional connectivity in patients with Parkinson's disease.
详细描述
The primary outcome measure is the change in sleep efficiency (the number of minutes asleep divided by the number of minutes in bed), as measured by polysomnography. In addition, because patients with Parkinson's disease have excessive sleepiness/impaired vigilance (alertness) and impaired motor function, and because these might be expected to improve with the exercise intervention, this study will also assess vigilance and motor outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •PD participants
- •Subjects with a clinical diagnosis of idiopathic Parkinson's disease based on the presence of bradykinesia and one or both of the following: rest tremor and/or rigidity
- •Hoehn and Yahr stage 2 or 3
- •Stable dopaminergic medication regimen for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- •Stable doses of medications known to affect sleep and medications for Parkinson's disease for at least 4 weeks prior to study entry without anticipation of medication change for the duration of the study.
- •Age 45 or greater at time of study entry
- •Asymmetric onset of PD
- •Progressive motor symptoms of PD
- •Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
- •MoCA score 18-26
- •Ability to travel to UAB 3x/week for the 16 weeks duration of the study for exercise training sessions as well as for other study visits
- •Subjects must pass a physical examination and PAR-Q to assess exercise readiness
- •Inclusion Criteria: Healthy Controls
- •Age 45 or greater at time of study entry
- •Poor sleep quality (Pittsburgh Sleep Quality Index score >5)
- •Normal cognition
排除标准
- •PD Participants
- •Atypical features indicative of a Parkinson's Plus disorder (Progressive Supranuclear Palsy, Multiple Systems Atrophy, Corticobasal Degeneration) including cerebellar signs, supranuclear gaze palsy, apraxia, prominent autonomic failure, or other cortical signs.
- •Neuroleptic treatment at time of onset of Parkinsonism
- •Active treatment with a neuroleptic at time of study entry
- •History of multiple strokes with stepwise progression of Parkinsonism
- •History of multiple head injuries
- •Inability to walk without assistance, including a cane, wheelchair, or walker
- •Regular participation in an exercise program within the past 6 months
- •Deep Brain Stimulation
- •Untreated sleep apnea
- •Known narcolepsy
- •Participation in drug studies or the use of investigational drugs within 30 days prior to screening
- •Acute illness or active, confounding medical, neurological, or musculoskeletal conditions that, at the discretion of the PI, would prevent the subject's ability to participate in the study
- •Known contraindication to testing
- •Active alcoholism or other drug addiction
- •Exclusion criteria for PD subjects undergoing imaging studies:
- •Pacemaker or other metallic object that would make MR imaging unsafe
- •Claustrophobia that prevents participation in imaging portion
- •Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion
- •Exclusion criteria for healthy controls:
- •Pacemaker or other metallic object that would make MR imaging unsafe
- •Claustrophobia that prevents participation in imaging portion
- •Any motor, cognitive, or health disorder that in the opinion of the PI would prevent the subject from participating in the imaging portion
研究组 & 干预措施
PD exercise group
Supervised exercise training, 3x per week for 16 weeks
干预措施: PD exercise (Behavioral)
PD sleep hygeine group
Tips for improved sleep hygiene, reading materials
干预措施: Sleep Hygiene (Behavioral)
Healthy control
MRI sub-study only
结局指标
主要结局
Motor outcome measured by Timed up and go test (TUG)
时间窗: baseline, week 18, and week 34
Timed up and go test (TUG)
Change in sleep efficiency measured by polysomnography
时间窗: baseline, week 18, and week 34
polysomnography
Vigilance outcome measured by psychomotor vigilance task (PVT)
时间窗: baseline, week 18, and week 34
psychomotor vigilance task (PVT)
次要结局
- MRI Sub-study(baseline (both PD and control), week 18 (PD only))
- Home sleep environment(baseline, week 18 and week 34)
研究者
Amy Amara, MD
Principal Investigator
University of Alabama at Birmingham