University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
NCT Number: NCT02593955
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.
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Notify Me45 year and older
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35294, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
PD participants
Inclusion criteria
Healthy Controls
Exclusion criteria
PD Participants
Exclusion criteria
for PD subjects undergoing imaging studies:
Exclusion criteria
for healthy controls:
Supervised high intensity exercise 3x/week for 16 weeks
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
Time frame: baseline, week 18, and week 34
polysomnography
Time frame: baseline, week 18, and week 34
psychomotor vigilance task (PVT)
Time frame: baseline, week 18, and week 34
Timed up and go test (TUG)
Time frame: baseline, week 18 and week 34
comparison of sleep diaries and actigraph related to home sleep environment
Time frame: baseline (both PD and control), week 18 (PD only)
comparison of PD and control imaging scans
University of Alabama at Birmingham
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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