The Effects of a High Intensity Exercise Training Program in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: PD exercise
* Behavioral: Sleep Hygiene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 Pregnancy 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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PD exercise group<br>Supervised exercise training, 3x per week for 16 weeks | Behavioral: PD exercise<br>* Supervised high intensity exercise 3x/week for 16 weeks<br>|
| Active Comparator: PD sleep hygeine group<br>Tips for improved sleep hygiene, reading materials | Behavioral: Sleep Hygiene<br>* Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.<br>|
| No Intervention: Healthy control<br>MRI sub-study only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep efficiency measured by polysomnography | polysomnography | baseline, week 18, and week 34 | 
| Vigilance outcome measured by psychomotor vigilance task (PVT) | psychomotor vigilance task (PVT) | baseline, week 18, and week 34 | 
| Motor outcome measured by Timed up and go test (TUG) | Timed up and go test (TUG) | baseline, week 18, and week 34 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home sleep environment | comparison of sleep diaries and actigraph related to home sleep environment | baseline, week 18 and week 34 | 
| MRI Sub-study | comparison of PD and control imaging scans | baseline (both PD and control), week 18 (PD only) |