Clinical trial NCT00167453: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Parkinson Disease
Keywords: Nervous system disease
movement disorder
exercise
balance
education
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Royal University Hospital Foundation
First posted: 2005-09-14
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: all variables measured at baseline, post intervention, months following, and 9 months following.
measure: Stanford Self-Efficacy for Managing Chronic Disease
measure: The Activities-specific Balance Confidence (ABC) Scale
measure: Timed Up and Go Test(TUG)
Secondary outcomes:
measure: Northwestern University Disability Scale:
measure: Schwab & England ADL Scale:) independence in ADL
measure: Parkinson's Disease Questionnaire - Short Form (PDQ - 8):
measure: Beliefs about Symptom Specific Expectancies:
measure: Social and Physical Activities Questionnaire:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: Saskatoon Health Region
name: M Suzanne Sheppard, PhD
role: PRINCIPAL_INVESTIGATOR
References: