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

NCT ID: NCT00167453

Last Updated: 2007-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Keywords

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Nervous system disease movement disorder exercise balance education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Exercise, Education

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal University Hospital Foundation

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Principal Investigators

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M Suzanne Sheppard, PhD

Role: PRINCIPAL_INVESTIGATOR

Saskatoon Health Region

Locations

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University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

References

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Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

Reference Type DERIVED
PMID: 38588457 (View on PubMed)

Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

Reference Type DERIVED
PMID: 36602886 (View on PubMed)

Other Identifiers

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Bio-REB 05-71

Identifier Type: -

Identifier Source: org_study_id