Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167453
Status:
COMPLETED
Last Update Posted:
2007-10-10
First Post:
2005-09-09
Brief Title:
Benefits of Exercise and Education for Individuals With Parkinsons Disease BEEP
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Evaluation of the Benefits of a Group Exercise Program and a Group Exercise and Education Program for Individuals With Parkinsons Disease BEEP
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Parkinsons Disease compared to a Control group and whether these benefits are maintained once the programs are complete and over the following 9 months
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 Parkinsons 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None