Structured Physical Activity for Sleep Quality and Daytime Sleepiness in Patients With Parkinson's Disease
|ClinicalTrials.gov Identifier: NCT01544465|
Recruitment Status : Terminated (Difficulty recruiting, funding lapsed)
First Posted : March 6, 2012
Last Update Posted : March 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Poor Quality Sleep Hypersomnia||Behavioral: Structured Physical Activity Behavioral: Sleep hygiene education||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effect of a Structured Physical Activity Program on Sleep Quality and Sleepiness in Parkinson's Disease|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
Experimental: Structured physical activity
Rehabilitation evaluation followed by physical therapy for approximately 8 weeks
Behavioral: Structured Physical Activity
Rehabilitation evaluation and 8 weeks of physical therapy
Active Comparator: Sleep hygiene education
Sleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine.
Behavioral: Structured Physical Activity
Rehabilitation evaluation and 8 weeks of physical therapyBehavioral: Sleep hygiene education
Educational materials on insomnia published by the American Academy of Sleep medicine
Other Name: Review of sleep hygiene checklist every 2 weeks via telephone for 8 weeks.
- Change in polysomnographically-derived wake after sleep onset [ Time Frame: Baseline and 10 weeks ]
- Change in mean sleep latency test-derived mean sleep latency [ Time Frame: Baseline and 10 weeks ]
- Change in Pittsburgh Sleep Quality Index [ Time Frame: Baseline and 10 weeks ]The Pittsburgh Sleep Quality Index is a survey-derived measure of sleep quality.
- Change in Epworth Sleepiness Scale [ Time Frame: Baseline and 10 weeks ]The Epworth Sleepiness Scale is a survey-derived measure of sleepiness
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01544465
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Phyllis C Zee, MD, PhD||Northwestern University|