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

March 20, 2014 updated by: Roneil Malkani, Northwestern University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 therapy
Behavioral: Sleep hygiene education
Educational materials on insomnia published by the American Academy of Sleep medicine
Other Names:
  • Review of sleep hygiene checklist every 2 weeks via telephone for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in polysomnographically-derived wake after sleep onset
Time Frame: Baseline and 10 weeks
Baseline and 10 weeks
Change in mean sleep latency test-derived mean sleep latency
Time Frame: Baseline and 10 weeks
Baseline and 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 10 weeks
Change in Epworth Sleepiness Scale
Time Frame: Baseline and 10 weeks
The Epworth Sleepiness Scale is a survey-derived measure of sleepiness
Baseline and 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Phyllis C Zee, MD, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 22, 2012

First Submitted That Met QC Criteria

February 28, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

March 21, 2014

Last Update Submitted That Met QC Criteria

March 20, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00045490
  • 67-PA-11 (Other Grant/Funding Number: American Sleep Medicine Foundation)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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