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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 71
- Locations
- 1
- Primary Endpoint
- Motor outcome measured by Timed up and go test (TUG)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Amy Amara, MD
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Motor outcome measured by Timed up and go test (TUG)
Time Frame: baseline, week 18, and week 34
Timed up and go test (TUG)
Change in sleep efficiency measured by polysomnography
Time Frame: baseline, week 18, and week 34
polysomnography
Vigilance outcome measured by psychomotor vigilance task (PVT)
Time Frame: baseline, week 18, and week 34
psychomotor vigilance task (PVT)
Secondary Outcomes
- MRI Sub-study(baseline (both PD and control), week 18 (PD only))
- Home sleep environment(baseline, week 18 and week 34)