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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23NS080912 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD exercise group | Active Comparator | Supervised exercise training, 3x per week for 16 weeks |
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| PD sleep hygeine group | Active Comparator | Tips for improved sleep hygiene, reading materials |
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| Healthy control | No Intervention | MRI sub-study only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD exercise | Behavioral | Supervised high intensity exercise 3x/week for 16 weeks |
| |
| 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 |
| 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 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Amara, MD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. | |
| 36602886 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sleep Hygiene |
| Behavioral |
Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials. |
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| baseline (both PD and control), week 18 (PD only) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |