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

This study has been terminated.
(Difficulty recruiting, funding lapsed)
Sponsor:
Collaborator:
Rehabilitation Institute of Chicago
Information provided by (Responsible Party):
Roneil Malkani, Northwestern University
ClinicalTrials.gov Identifier:
NCT01544465
First received: February 22, 2012
Last updated: March 20, 2014
Last verified: March 2014

February 22, 2012
March 20, 2014
August 2011
March 2014   (final data collection date for primary outcome measure)
  • Change in polysomnographically-derived wake after sleep onset [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
  • Change in mean sleep latency test-derived mean sleep latency [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01544465 on ClinicalTrials.gov Archive Site
  • Change in Pittsburgh Sleep Quality Index [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    The Pittsburgh Sleep Quality Index is a survey-derived measure of sleep quality.
  • Change in Epworth Sleepiness Scale [ Time Frame: Baseline and 10 weeks ] [ Designated as safety issue: No ]
    The Epworth Sleepiness Scale is a survey-derived measure of sleepiness
Same as current
Not Provided
Not Provided
 
Structured Physical Activity for Sleep Quality and Daytime Sleepiness in Patients With Parkinson's Disease
Effect of a Structured Physical Activity Program on Sleep Quality and Sleepiness in Parkinson's Disease

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Poor Quality Sleep
  • Hypersomnia
  • Behavioral: Structured Physical Activity
    Rehabilitation evaluation and 8 weeks of physical therapy
  • Behavioral: 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.
  • Experimental: Structured physical activity
    Rehabilitation evaluation followed by physical therapy for approximately 8 weeks
    Intervention: Behavioral: Structured Physical Activity
  • Active Comparator: Sleep hygiene education
    Sleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine.
    Interventions:
    • Behavioral: Structured Physical Activity
    • Behavioral: Sleep hygiene education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01544465
STU00045490, 67-PA-11​
No
Roneil Malkani, Northwestern University
Northwestern University
Rehabilitation Institute of Chicago
Principal Investigator: Phyllis C Zee, MD, PhD Northwestern University
Northwestern University
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP