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)

Status: Completed
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: t
View:

• 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

• Age 45 or greater at time of study entry

• Poor sleep quality (Pittsburgh Sleep Quality Index score \>5)

• Normal cognition

Locations
United States
Alabama
University of Alabama at Birmingham
Birmingham
Time Frame
Start Date: 2018-11-30
Completion Date: 2018-11-30
Participants
Target number of participants: 71
Treatments
Active_comparator: PD exercise group
Supervised exercise training, 3x per week for 16 weeks
Active_comparator: PD sleep hygeine group
Tips for improved sleep hygiene, reading materials
No_intervention: Healthy control
MRI sub-study only
Authors
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov