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

October 4, 2007 updated by: University of Saskatchewan

Evaluation of the Benefits of a Group Exercise Program and a Group Exercise and Education Program for Individuals With Parkinson's Disease (BEEP)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5C8
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Collaborators

Royal University Hospital Foundation

Investigators

  • Principal Investigator: M Suzanne Sheppard, PhD, Saskatoon Health Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

October 10, 2007

Last Update Submitted That Met QC Criteria

October 4, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio-REB 05-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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