Clinical Trial: Structured Physical Activity for Sleep Quality and Daytime Sleepiness in Patients With Parkinson's Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effect of a Structured Physical Activity Program on Sleep Quality and Sleepiness in Parkinson's Disease

Brief Summary: 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.

Detailed Summary:

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 t
Sponsor: Northwestern University

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: February 22, 2012
Date Started: August 2011
Date Completion:
Last Updated: March 20, 2014
Last Verified: March 2014