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

Stopped early · Not applicable

Conditions studied: Parkinson's Disease, Poor Quality Sleep, Hypersomnia

In brief

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.

Key facts

Study ID

NCT01544465

Run by

Northwestern University

People needed

1

Starts

2011-08-01

Expected to finish

2014-03-01

Last updated by the study team

2014-03-21

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northwestern University — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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