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| ID | Type | Description | Link |
|---|---|---|---|
| 67-PA-11 | Other Grant/Funding Number | American Sleep Medicine Foundation |
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Difficulty recruiting, funding lapsed
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| Name | Class |
|---|---|
| Shirley Ryan AbilityLab | OTHER |
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The purpose of this study is to examine the ability of a structured physical activity program to improve sleep quality and daytime sleepiness in patients with Parkinson's disease.
Parkinson's disease (PD) is a chronic, progressive, neurodegenerative disease that affects 1% of elderly people. Sleep disturbances affect up to 88% of patients with PD and commonly include sleep fragmentation and excessive daytime sleepiness (EDS); these symptoms can significantly impair quality of life. The cause of sleep fragmentation and EDS is likely multifactorial, including medications, neurodegeneration, primary sleep disorders such as sleep apnea, and decreased physical activity. Pharmacotherapy in this population is limited due to side effects and drug-drug interactions.
The goal of this project is to develop non-pharmacologic therapies for impaired sleep quality and EDS in PD. Sleep disturbances and EDS are common among patients with PD and negatively affect their quality of life. There is data to support a role for physical activity in sleep in older adults with and without insomnia. Additionally, increased physical activity in patients with PD has been associated with improvement in PD motor symptoms and quality of life. Therefore, the investigators propose to examine the ability of structured physical activity to improve sleep quality and daytime sleepiness in patients with PD.
The overall objective of the proposed project is to develop behavioral approaches to improve sleep quality and daytime function in PD. The investigators propose to examine the effect of a structured physical activity program and sleep hygiene education on nighttime sleep quality and EDS in patients with idiopathic PD. There will be two groups: 1) a structured physical activity program with sleep hygiene education (SPA group), and 2) a control group receiving only sleep hygiene education (SH group) who will be offered the delayed physical activity program.
The investigators hypothesize that the structured physical activity program will improve subjective and objective sleep quality and daytime sleepiness compared to sleep hygiene education alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured physical activity | Experimental | Rehabilitation evaluation followed by physical therapy for approximately 8 weeks |
|
| Sleep hygiene education | Active Comparator | Sleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured Physical Activity | Behavioral | Rehabilitation evaluation and 8 weeks of physical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in polysomnographically-derived wake after sleep onset | Baseline and 10 weeks | |
| Change in mean sleep latency test-derived mean sleep latency | Baseline and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index is a survey-derived measure of sleep quality. | Baseline and 10 weeks |
| Change in Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a survey-derived measure of sleepiness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phyllis C Zee, MD, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17261678 | Background | Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the "common" neurologic disorders? Neurology. 2007 Jan 30;68(5):326-37. doi: 10.1212/01.wnl.0000252807.38124.a3. | |
| 20187236 | Background | Menza M, Dobkin RD, Marin H, Bienfait K. Sleep disturbances in Parkinson's disease. Mov Disord. 2010;25 Suppl 1(Suppl 1):S117-22. doi: 10.1002/mds.22788. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006970 | Disorders of Excessive Somnolence |
| D007319 | Sleep Initiation and Maintenance Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Sleep hygiene education | Behavioral | Educational materials on insomnia published by the American Academy of Sleep medicine |
|
|
| Baseline and 10 weeks |
| 11673578 | Background | Ondo WG, Dat Vuong K, Khan H, Atassi F, Kwak C, Jankovic J. Daytime sleepiness and other sleep disorders in Parkinson's disease. Neurology. 2001 Oct 23;57(8):1392-6. doi: 10.1212/wnl.57.8.1392. |
| 8980207 | Background | King AC, Oman RF, Brassington GS, Bliwise DL, Haskell WL. Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA. 1997 Jan 1;277(1):32-7. |
| 15161452 | Background | Li F, Fisher KJ, Harmer P, Irbe D, Tearse RG, Weimer C. Tai chi and self-rated quality of sleep and daytime sleepiness in older adults: a randomized controlled trial. J Am Geriatr Soc. 2004 Jun;52(6):892-900. doi: 10.1111/j.1532-5415.2004.52255.x. |
| 20813580 | Background | Reid KJ, Baron KG, Lu B, Naylor E, Wolfe L, Zee PC. Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med. 2010 Oct;11(9):934-40. doi: 10.1016/j.sleep.2010.04.014. Epub 2010 Sep 1. |
| 11322151 | Background | Baatile J, Langbein WE, Weaver F, Maloney C, Jost MB. Effect of exercise on perceived quality of life of individuals with Parkinson's disease. J Rehabil Res Dev. 2000 Sep-Oct;37(5):529-34. |
| 16637049 | Background | Rodrigues de Paula F, Teixeira-Salmela LF, Coelho de Morais Faria CD, Rocha de Brito P, Cardoso F. Impact of an exercise program on physical, emotional, and social aspects of quality of life of individuals with Parkinson's disease. Mov Disord. 2006 Aug;21(8):1073-7. doi: 10.1002/mds.20763. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |