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

This study has been completed.
Sponsor:
Collaborator:
Royal University Hospital Foundation
Information provided by:
University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT00167453
First received: September 9, 2005
Last updated: October 4, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Parkinson Disease
Procedure: Exercise, Education
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Evaluation of the Benefits of a Group Exercise Program and a Group Exercise and Education Program for Individuals With Parkinson's Disease (BEEP)

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • 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)

Secondary Outcome Measures:
  • 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:

Estimated Enrollment: 45
Study Start Date: September 2005
Study Completion Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00167453

Locations
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 5C8
Sponsors and Collaborators
University of Saskatchewan
Royal University Hospital Foundation
Investigators
Principal Investigator: M Suzanne Sheppard, PhD Saskatoon Health Region
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00167453     History of Changes
Other Study ID Numbers: Bio-REB 05-71
Study First Received: September 9, 2005
Last Updated: October 4, 2007
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:
Nervous system disease
movement disorder
exercise
balance
education

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 25, 2014