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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Exercise, Education
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Nervous system disease, movement disorder, exercise, balance, education

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Saskatchewan

Outcomes

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:

Full Information

First Posted
September 9, 2005
Last Updated
October 4, 2007
Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00167453
Brief Title
Benefits of Exercise and Education for Individuals With Parkinson's Disease (BEEP)
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 Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Saskatchewan
Collaborators
Royal University Hospital Foundation

4. Oversight

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Nervous system disease, movement disorder, exercise, balance, education

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Exercise, Education
Primary Outcome Measure Information:
Title
all variables measured at baseline, post intervention, months following, and 9 months following.
Title
Stanford Self-Efficacy for Managing Chronic Disease
Title
The Activities-specific Balance Confidence (ABC) Scale
Title
Timed Up and Go Test(TUG)
Secondary Outcome Measure Information:
Title
Northwestern University Disability Scale:
Title
Schwab & England ADL Scale:) independence in ADL
Title
Parkinson's Disease Questionnaire - Short Form (PDQ - 8):
Title
Beliefs about Symptom Specific Expectancies:
Title
Social and Physical Activities Questionnaire:

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M Suzanne Sheppard, PhD
Organizational Affiliation
Saskatoon Health Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5C8
Country
Canada

12. IPD Sharing Statement

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

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