Parkinson's Disease Clinical Trial
Official title:
Effect of a Structured Physical Activity Program on Sleep Quality and Sleepiness in Parkinson's Disease
Verified date | March 2014 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Established clinical diagnosis of Hoehn and Yahr stage I to III idiopathic Parkinson's disease, - Male and female. - Age of onset of PD >= 50 years; - Impaired sleep quality determined by Parkinson's disease sleep scale (PDSS-2) total score = 12; - EDS as determined by Epworth Sleepiness Scale (ESS) > 10; - Sedentary (< 30 minutes/day or < 2 times/week of exercise) based on physical activity history; - Stable on medications for PD for at least 2 months; - After clinical evaluation, was provided with a referral by their Movement Disorders Neurologist for an evaluation at the Movement Disorders Rehabilitation Evaluation Clinic at the Rehabilitation Institute of Chicago. Exclusion Criteria: - Cognitive impairment as determined by Montreal Cognitive Assessment (MoCA) total score < 25; - High likelihood of sleep disordered breathing as determined by the Berlin Questionnaire (BQ); - Restless legs syndrome (RLS) based on the International RLS Study Group diagnostic criteria; - Current use of any sedative/hypnotics or stimulants, tricyclic antidepressants, and trazodone; - Use of selective serotonin reuptake inhibitors (SSRIs) and bupropion will be allowed only if the patient has been on a stable dose for at least three months; - Unstable medical or psychiatric condition; - History of falls in the last 2 months; - Participants with parasomnias such as Rapid Eye Movement Behavior Disorder will not be excluded as up to 50% of patients with PD have parasomnias and exclusion of these patients would result in difficulty with recruitment and the results would be less generalizable; - Current depression based on BDI-II total score > 19; - Current occupation involves shift work; - At visit #2, Apnea-hypopnea index >15 on baseline PSG; - At visit #2, Periodic limb movements in sleep index >15 on baseline PSG; - At physiatry evaluation at RIC, inpatient rehabilitation is recommended. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | Rehabilitation Institute of Chicago |
United States,
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. — View Citation
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. — View Citation
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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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in polysomnographically-derived wake after sleep onset | Baseline and 10 weeks | No | |
Primary | Change in mean sleep latency test-derived mean sleep latency | Baseline and 10 weeks | No | |
Secondary | Change in Pittsburgh Sleep Quality Index | The Pittsburgh Sleep Quality Index is a survey-derived measure of sleep quality. | Baseline and 10 weeks | No |
Secondary | Change in Epworth Sleepiness Scale | The Epworth Sleepiness Scale is a survey-derived measure of sleepiness | Baseline and 10 weeks | No |
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