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



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:50 - Any
Updated:5/3/2014
Start Date:August 2011
End Date:June 2013
Contact:Roneil G Malkani, MD, MS
Email:r-malkani@fsm.northwestern.edu
Phone:312-503-1264

Use our guide to learn which trials are right for you!

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.

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 PDSS-2 total score ≥ 12;

- EDS as determined by 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.
We found this trial at
1
site
201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
?
mi
from
Chicago, IL
Click here to add this to my saved trials