NCT01544465

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

2.6 years

First QC Date

February 22, 2012

Last Update Submit

March 20, 2014

Conditions

Parkinson's DiseasePoor Quality SleepHypersomnia

Keywords

Parkinson's diseaseSleep QualityDaytime sleepinessphysical therapyexercise

Outcome Measures

Primary Outcomes (2)

  • Change in polysomnographically-derived wake after sleep onset

    Baseline and 10 weeks

  • Change in mean sleep latency test-derived mean sleep latency

    Baseline and 10 weeks

Secondary Outcomes (2)

  • Change in Pittsburgh Sleep Quality Index

    Baseline and 10 weeks

  • Change in Epworth Sleepiness Scale

    Baseline and 10 weeks

Study Arms (2)

Structured physical activity

EXPERIMENTAL

Rehabilitation evaluation followed by physical therapy for approximately 8 weeks

Behavioral: Structured Physical Activity

Sleep hygiene education

ACTIVE COMPARATOR

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

Behavioral: Structured Physical ActivityBehavioral: Sleep hygiene education

Interventions

Structured Physical ActivityBEHAVIORAL

Rehabilitation evaluation and 8 weeks of physical therapy

Sleep hygiene educationStructured physical activity
Sleep hygiene educationBEHAVIORAL

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

Also known as: Review of sleep hygiene checklist every 2 weeks via telephone for 8 weeks.
Sleep hygiene education

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (8)

  • 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.

    PMID: 17261678BACKGROUND

  • 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.

    PMID: 20187236BACKGROUND

  • 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.

    PMID: 11673578BACKGROUND

  • 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.

    PMID: 8980207BACKGROUND

  • 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.

    PMID: 15161452BACKGROUND

  • 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.

    PMID: 20813580BACKGROUND

  • 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.

    PMID: 11322151BACKGROUND

  • 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.

    PMID: 16637049BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDisorders of Excessive SomnolenceSleep Initiation and Maintenance DisordersMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental DisordersBehavior

Study Officials

  • Phyllis C Zee, MD, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 22, 2012

First Posted

March 6, 2012

Study Start

August 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

US(1)