Benefits of Exercise and Education for Individuals With Parkinson's Disease (BEEP)
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|ClinicalTrials.gov Identifier: NCT00167453|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : October 10, 2007
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: Exercise, Education||Phase 1|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|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)|
|Study Start Date :||September 2005|
|Actual Study Completion Date :||May 2007|
- 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)
- 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:
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167453
|University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7N 5C8|
|Principal Investigator:||M Suzanne Sheppard, PhD||Saskatoon Health Region|