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

20. marts 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Structured physical activity
Rehabilitation evaluation followed by physical therapy for approximately 8 weeks
Adfærdsmæssigt: Structured Physical Activity
Rehabilitation evaluation and 8 weeks of physical therapy
Aktiv komparator: Sleep hygiene education
Sleep hygiene education consists of educational materials on insomnia published by the American Academy of Sleep Medicine.
Adfærdsmæssigt: Structured Physical Activity
Rehabilitation evaluation and 8 weeks of physical therapy
Adfærdsmæssigt: Sleep hygiene education
Educational materials on insomnia published by the American Academy of Sleep medicine
Andre navne:
  • Review of sleep hygiene checklist every 2 weeks via telephone for 8 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change in polysomnographically-derived wake after sleep onset
Tidsramme: Baseline and 10 weeks
Baseline and 10 weeks
Change in mean sleep latency test-derived mean sleep latency
Tidsramme: Baseline and 10 weeks
Baseline and 10 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pittsburgh Sleep Quality Index
Tidsramme: 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
Tidsramme: Baseline and 10 weeks
The Epworth Sleepiness Scale is a survey-derived measure of sleepiness
Baseline and 10 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Northwestern University

Samarbejdspartnere

Shirley Ryan AbilityLab

Efterforskere

  • Ledende efterforsker: Phyllis C Zee, MD, PhD, Northwestern University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2011

Primær færdiggørelse (Faktiske)

1. marts 2014

Studieafslutning (Faktiske)

1. marts 2014

Datoer for studieregistrering

Først indsendt

22. februar 2012

Først indsendt, der opfyldte QC-kriterier

28. februar 2012

Først opslået (Skøn)

6. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. marts 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STU00045490
  • 67-PA-11 (Andet bevillings-/finansieringsnummer: American Sleep Medicine Foundation)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Structured Physical Activity

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kazakhstan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner