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

Primary Purpose

Parkinson's Disease, Poor Quality Sleep, Hypersomnia

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Structured Physical Activity

Sleep hygiene education

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Sleep Quality, Daytime sleepiness, physical therapy, exercise

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Structured physical activity

Sleep hygiene education

Arm Description

Rehabilitation evaluation followed by physical therapy for approximately 8 weeks

Sleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine.

Outcomes

Primary Outcome Measures

Change in polysomnographically-derived wake after sleep onset

Change in mean sleep latency test-derived mean sleep latency

Secondary Outcome Measures

Change in Pittsburgh Sleep Quality Index

The Pittsburgh Sleep Quality Index is a survey-derived measure of sleep quality.

Change in Epworth Sleepiness Scale

The Epworth Sleepiness Scale is a survey-derived measure of sleepiness

Full Information

NCT ID

NCT01544465

First Posted

February 22, 2012

Last Updated

March 20, 2014

Sponsor

Northwestern University

Collaborators

Shirley Ryan AbilityLab

1. Study Identification

Unique Protocol Identification Number

NCT01544465

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Difficulty recruiting, funding lapsed

Study Start Date

August 2011 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

Collaborators

Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Poor Quality Sleep, Hypersomnia

Keywords

Parkinson's disease, Sleep Quality, Daytime sleepiness, physical therapy, exercise

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Structured physical activity

Arm Type

Experimental

Arm Description

Rehabilitation evaluation followed by physical therapy for approximately 8 weeks

Arm Title

Sleep hygiene education

Arm Type

Active Comparator

Arm Description

Sleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine.

Intervention Type

Behavioral

Intervention Name(s)

Structured Physical Activity

Intervention Description

Rehabilitation evaluation and 8 weeks of physical therapy

Intervention Type

Behavioral

Intervention Name(s)

Sleep hygiene education

Other Intervention Name(s)

Review of sleep hygiene checklist every 2 weeks via telephone for 8 weeks.

Intervention Description

Educational materials on insomnia published by the American Academy of Sleep medicine

Primary Outcome Measure Information:

Title

Change in polysomnographically-derived wake after sleep onset

Time Frame

Baseline and 10 weeks

Title

Change in mean sleep latency test-derived mean sleep latency

Time Frame

Baseline and 10 weeks

Secondary Outcome Measure Information:

Title

Change in Pittsburgh Sleep Quality Index

Description

The Pittsburgh Sleep Quality Index is a survey-derived measure of sleep quality.

Time Frame

Baseline and 10 weeks

Title

Change in Epworth Sleepiness Scale

Description

The Epworth Sleepiness Scale is a survey-derived measure of sleepiness

Time Frame

Baseline and 10 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Phyllis C Zee, MD, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17261678

Citation

Hirtz D, Thurman DJ, Gwinn-Hardy K, Mohamed M, Chaudhuri AR, Zalutsky R. How common are the "common" neurologic disorders? Neurology. 2007 Jan 30;68(5):326-37. doi: 10.1212/01.wnl.0000252807.38124.a3.

Results Reference

background

PubMed Identifier

20187236

Citation

Menza M, Dobkin RD, Marin H, Bienfait K. Sleep disturbances in Parkinson's disease. Mov Disord. 2010;25 Suppl 1(Suppl 1):S117-22. doi: 10.1002/mds.22788.

Results Reference

background

PubMed Identifier

11673578

Citation

Ondo WG, Dat Vuong K, Khan H, Atassi F, Kwak C, Jankovic J. Daytime sleepiness and other sleep disorders in Parkinson's disease. Neurology. 2001 Oct 23;57(8):1392-6. doi: 10.1212/wnl.57.8.1392.

Results Reference

background

PubMed Identifier

8980207

Citation

King AC, Oman RF, Brassington GS, Bliwise DL, Haskell WL. Moderate-intensity exercise and self-rated quality of sleep in older adults. A randomized controlled trial. JAMA. 1997 Jan 1;277(1):32-7.

Results Reference

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PubMed Identifier

15161452

Citation

Li F, Fisher KJ, Harmer P, Irbe D, Tearse RG, Weimer C. Tai chi and self-rated quality of sleep and daytime sleepiness in older adults: a randomized controlled trial. J Am Geriatr Soc. 2004 Jun;52(6):892-900. doi: 10.1111/j.1532-5415.2004.52255.x.

Results Reference

background

PubMed Identifier

20813580

Citation

Reid KJ, Baron KG, Lu B, Naylor E, Wolfe L, Zee PC. Aerobic exercise improves self-reported sleep and quality of life in older adults with insomnia. Sleep Med. 2010 Oct;11(9):934-40. doi: 10.1016/j.sleep.2010.04.014. Epub 2010 Sep 1.

Results Reference

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PubMed Identifier

11322151

Citation

Baatile J, Langbein WE, Weaver F, Maloney C, Jost MB. Effect of exercise on perceived quality of life of individuals with Parkinson's disease. J Rehabil Res Dev. 2000 Sep-Oct;37(5):529-34.

Results Reference

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PubMed Identifier

16637049

Citation

Rodrigues de Paula F, Teixeira-Salmela LF, Coelho de Morais Faria CD, Rocha de Brito P, Cardoso F. Impact of an exercise program on physical, emotional, and social aspects of quality of life of individuals with Parkinson's disease. Mov Disord. 2006 Aug;21(8):1073-7. doi: 10.1002/mds.20763.

Results Reference

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

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