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Benefits of Exercise and Education for Individuals With Parkinson's Disease (BEEP)

4. oktober 2007 opdateret af: University of Saskatchewan

Evaluation of the Benefits of a Group Exercise Program and a Group Exercise and Education Program for Individuals With Parkinson's Disease (BEEP)

The research outlined in the BEEP proposal aims to test whether a 12 week exercise program alone or combined with a 12 session education program will benefit the physical, emotional and social well being of individuals in early to mid stages of Parkinson's Disease compared to a Control group and whether these benefits are maintained once the programs are complete and over the following 9 months.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The BEEP proposal tests whether a 12 week exercise program alone or combined with a 12 session education program will benefit the physical, emotional and social well being of individuals in early to mid stages of Parkinson's Disease and whether these benefits are maintained once the programs are complete.

This is a single blind randomized control trial with pretest and posttests after a 3 month intervention and subsequent follow-up testing at 3 months and 9 months post intervention. The Intervention groups (group exercise, group exercise and education) will be compared to a control group and to each other. Each group will have 15 participants.

The study compares the interventions and control groups to determine the following health outcomes:

  • physical performance
  • levels of physical and social activity
  • perceived quality of life
  • perceived self efficacy for managing chronic neurological disease

Analysis of variance will be used to test for group differences.

The Interventions: Exercise Group: Two, 75 minute sessions per week for 24 sessions. Program components include flexibility and strengthening exercises, balance and posture training, practice of functional tasks and endurance training. Education and Exercise Group: Exercise, same as for Exercise Group, delivered simultaneously to both intervention groups.

Education: One, 75 minute session per week for 12 sessions at RUH, including:

  • disease process and clinical presentation
  • medication use in PD
  • benefits of exercise
  • managing movement difficulties and tips for performance of functional activities
  • assistive devices for improved independence and safety
  • driving
  • prevention of falls: movement strategies and home modifications to increase safety
  • speech, swallowing and facial expression
  • nutrition and weight maintenance, managing constipation
  • managing changes in mood & emotions, managing personal relationships
  • coping with life changes caused by PD
  • relaxation methods

Monitoring will occur to limit "informal" education that might occur during the exercise program from this group to the pure Exercise Group.

Control Group: no intervention The proposed study will add to the body of evidence evaluating the immediate and longer term benefits of group exercise programs for individuals with PD and will evaluate the benefits gained by adding an education program to an exercise program intervention.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

45

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5C8
        • University of Saskatchewan

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

40 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease or Parkinson Syndrome
  • Stages I-III of disease progression
  • Between 40 and 80 years of age

Exclusion criteria:

  • Acute illness
  • History of significant cardio-pulmonary insufficiency/illness or any other condition which limits physical activity.
  • History of neurological disorder other than Parkinson Disease
  • Diagnosis of dementia or significant cognitive impairments.
  • Mental State Exam (Folstein et al, 1975) score of < 20
  • Beck Depression Inventory-II score of > 20 will be excluded.
  • Participation in an organized community exercise program in the past 6 months

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
all variables measured at baseline, post intervention, months following, and 9 months following.
Stanford Self-Efficacy for Managing Chronic Disease
The Activities-specific Balance Confidence (ABC) Scale
Timed Up and Go Test(TUG)

Sekundære resultatmål

Resultatmål
Northwestern University Disability Scale:
Schwab & England ADL Scale:) independence in ADL
Parkinson's Disease Questionnaire - Short Form (PDQ - 8):
Beliefs about Symptom Specific Expectancies:
Social and Physical Activities Questionnaire:

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: M Suzanne Sheppard, PhD, Saskatoon Health Region

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. september 2005

Studieafslutning (Faktiske)

1. maj 2007

Datoer for studieregistrering

Først indsendt

9. september 2005

Først indsendt, der opfyldte QC-kriterier

9. september 2005

Først opslået (Skøn)

14. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. oktober 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. oktober 2007

Sidst verificeret

1. september 2006

Mere information

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 .

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