NCT00167453

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P75+ for phase_1 parkinson-disease

Timeline
Completed

Started Sep 2005

Typical duration for phase_1 parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

October 10, 2007

Status Verified

September 1, 2006

First QC Date

September 9, 2005

Last Update Submit

October 4, 2007

Conditions

Parkinson Disease

Keywords

Nervous system diseasemovement disorderexercisebalanceeducation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (5)

  • 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:

Interventions

Exercise, EducationPROCEDURE

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Parkinson's Disease or Parkinson Syndrome
  • Stages I-III of disease progression
  • Between 40 and 80 years of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5C8, Canada

Location

Related Publications (2)

  • 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.

    PMID: 38588457DERIVED

  • 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.

    PMID: 36602886DERIVED

MeSH Terms

Conditions

Parkinson DiseaseNervous System DiseasesMovement DisordersMotor Activity

Interventions

ExerciseEducational Status

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesSynucleinopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • M Suzanne Sheppard, PhD

    Saskatoon Health Region

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2005

Study Completion

May 1, 2007

Last Updated

October 10, 2007

Record last verified: 2006-09

Locations

CA(1)