NCT00261781

Brief Summary

The major aim of this study is to determine the efficacy of a home-based treadmill walking program in improving walking capacity and quality of life in people with early mid-stage Parkinson's disease(PD).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.6 years

First QC Date

December 1, 2005

Last Update Submit

May 27, 2015

Conditions

Idiopathic Parkinson's Disease

Keywords

TreadmillWalkingExerciseAutomaticityQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Distance walked in 6 minutes

    study entry (0 weeks), 7 and 13 weeks

Secondary Outcomes (4)

  • Unified Parkinson's disease Rating Scale (UPDRS) - motor examination

    0, 7 and 13 weeks

  • The Parkinson's disease Questionnaire (PDQ-39

    0, 7 and 13 weeks

  • Walking Automaticity, determined as the velocity of walking 10m while performing a concurrent (cognitive or cognitive + physical) task expressed as a percentage of the velocity of walking 10m without performing the concurrent task.

    0, 7 and 13 weeks

  • Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.

    0, 7 and 13 weeks

Study Arms (2)

Treadmill training

EXPERIMENTAL

Home-based treadmill training

Behavioral: Treadmill training

Usual care

NO INTERVENTION

Control group

Interventions

Treadmill trainingBEHAVIORAL

Walking on a treadmill 3 times per week for 6 weeks

Treadmill training

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinical diagnosis of idiopathic Parkinson's disease
  • aged 30-80 years old
  • subjective disturbance of gait and / or Unified Parkinson's disease rating scale (UPDRS) gait subscore of 1
  • sedentary, defined as performing less than 2 hours / week of leisure-time physical activity over the prior 3 months
  • have adapted to their current anti-Parkinsonian medication for at least 2 weeks

You may not qualify if:

  • motor fluctuations or dyskinesias which are disabling
  • require the use of a walking aid
  • more than one fall in the last 12 months
  • Mini-Mental State Examination score of \<24
  • exhibit other neurological or musculoskeletal conditions affecting walking
  • chest pain at rest or during exercise in the last 3 months, or heart attack, angioplasty or heart surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westmead Hospital

Sydney, New South Wales, 2145, Australia

Location

Related Publications (4)

  • Ashburn A, Stack E, Pickering RM, Ward CD. A community-dwelling sample of people with Parkinson's disease: characteristics of fallers and non-fallers. Age Ageing. 2001 Jan;30(1):47-52. doi: 10.1093/ageing/30.1.47.

    PMID: 11322672BACKGROUND

  • Canning CG, Alison JA, Allen NE, Groeller H. Parkinson's disease: an investigation of exercise capacity, respiratory function, and gait. Arch Phys Med Rehabil. 1997 Feb;78(2):199-207. doi: 10.1016/s0003-9993(97)90264-1.

    PMID: 9041903BACKGROUND

  • Playfer JR. Falls and Parkinson's disease. Age Ageing. 2001 Jan;30(1):3-4. doi: 10.1093/ageing/30.1.3. No abstract available.

    PMID: 11322669BACKGROUND

  • Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Home-based treadmill training for individuals with Parkinson's disease: a randomized controlled pilot trial. Clin Rehabil. 2012 Sep;26(9):817-26. doi: 10.1177/0269215511432652. Epub 2012 Jan 18.

    PMID: 22257506RESULT

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Colleen G Canning, PhD

    University of Sydney

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr Natalie allen

Study Record Dates

First Submitted

December 1, 2005

First Posted

December 5, 2005

Study Start

May 1, 2005

Primary Completion

December 1, 2006

Study Completion

September 1, 2012

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

AU(1)