Parkinson's Disease
Conditions
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.
Interventions
BEHAVIORALPD exercise
Supervised high intensity exercise 3x/week for 16 weeks
BEHAVIORALSleep Hygiene
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
Sponsors
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PD participants 1. 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 2. Hoehn and Yahr stage 2 or 3 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. 4. 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. 5. Age 45 or greater at time of study entry 6. Asymmetric onset of PD 7. Progressive motor symptoms of PD 8. Poor sleep quality (Pittsburgh Sleep Quality Index score \>5) 9. MoCA score 18-26 10. 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 11. Subjects must pass a physical examination and PAR-Q to assess exercise readiness Inclusion Criteria: Healthy Controls 1. Age 45 or greater at time of study entry 2. Poor sleep quality (Pittsburgh Sleep Quality Index score \>5) 3. Normal cognition
Exclusion criteria
PD Participants 1. 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. 2. Neuroleptic treatment at time of onset of Parkinsonism 3. Active treatment with a neuroleptic at time of study entry 4. History of multiple strokes with stepwise progression of Parkinsonism 5. History of multiple head injuries 6. Inability to walk without assistance, including a cane, wheelchair, or walker 7. Regular participation in an exercise program within the past 6 months 8. Deep Brain Stimulation 9. Untreated sleep apnea 10. Known narcolepsy 11. Participation in drug studies or the use of investigational drugs within 30 days prior to screening 12. 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 13. Known contraindication to testing 14. Active alcoholism or other drug addiction 15. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep efficiency measured by polysomnography | baseline, week 18, and week 34 | polysomnography |
| Vigilance outcome measured by psychomotor vigilance task (PVT) | baseline, week 18, and week 34 | psychomotor vigilance task (PVT) |
| Motor outcome measured by Timed up and go test (TUG) | baseline, week 18, and week 34 | Timed up and go test (TUG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Home sleep environment | baseline, week 18 and week 34 | comparison of sleep diaries and actigraph related to home sleep environment |
| MRI Sub-study | baseline (both PD and control), week 18 (PD only) | comparison of PD and control imaging scans |
Countries
United States
Outcome results
None listed