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Parkinson's DiseaseNCT01544465

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

A study testing Structured Physical Activity and Sleep hygiene education in people with Parkinson's Disease and Poor Quality Sleep, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Structured Physical Activity and Sleep hygiene education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
Aug 2011to Mar 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Structured Physical Activity, Sleep hygiene education
Keywords
Parkinson's disease, Sleep Quality, Daytime sleepiness, physical therapy, exercise
Medical subject headings
Parkinson Disease, Disorders of Excessive Somnolence, Sleep Initiation and Maintenance Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured Physical ActivityBehavioural

    Rehabilitation evaluation and 8 weeks of physical therapy

  • Sleep hygiene educationBehavioural

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

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

Study groups in NCT01544465
Study groupRoleWhat they receive
Structured physical activityExperimentalRehabilitation evaluation followed by physical therapy for approximately 8 weeks
Receives: Behavioral: Structured Physical Activity
Sleep hygiene educationActive comparatorSleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine.
Receives: Behavioral: Structured Physical Activity; Behavioral: Sleep hygiene education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in polysomnographically-derived wake after sleep onset

    Measured: Baseline and 10 weeks

  2. Change in mean sleep latency test-derived mean sleep latency

    Measured: Baseline and 10 weeks

Secondary outcomes (2)

  1. Change in Pittsburgh Sleep Quality Index

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

    Measured: Baseline and 10 weeks

  2. Change in Epworth Sleepiness Scale

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

    Measured: Baseline and 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionMar 2014
  4. Study completionMar 2014

Why it stopped: Difficulty recruiting, funding lapsed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01544465
Sponsor's protocol ID
STU00045490
Other IDs
67-PA-11
Status last verified
Mar 2014
First submitted
22 Feb 2012
Last updated
21 Mar 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17261678

  • 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.

    PubMed 20187236

  • 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.

    PubMed 11673578

  • 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.

    PubMed 8980207

  • 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.

    PubMed 15161452

  • 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.

    PubMed 20813580

  • 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.

    PubMed 11322151

  • 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.

    PubMed 16637049

Questions about this trial

What is this clinical trial studying?

A study testing Structured Physical Activity and Sleep hygiene education in people with Parkinson's Disease and Poor Quality Sleep, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Difficulty recruiting, funding lapsed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in polysomnographically-derived wake after sleep onset (time frame: Baseline and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01544465, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2014.

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