Walking Capacity in Parkinson's Disease (PD-Walk)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261781
Recruitment Status : Terminated (20 subjects completed for a pilot, further funding required to continue study)
First Posted : December 5, 2005
Last Update Posted : May 29, 2015
South West Sydney Local Health District
Information provided by (Responsible Party):
Natalie Allen, University of Sydney

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).

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Behavioral: Treadmill training Not Applicable

Detailed Description:

After Alzheimer's disease, Parkinson's disease (PD) is the most common degenerative neurological condition suffered by Australians, with more than 30,000 Australians having PD at any one time (Parkinson's Australia). Hypokinesia, ie, reduced speed and amplitude of movement, is a major impairment of motor control affecting walking in people with PD. Over time, the development of slow, shuffling walking contributes to loss of independence and falls, with devastating consequences for individuals with PD and their families(Ashburn et al, 2001, Playfer 2001). Any decrease or delay in disability will reduce the personal and financial costs to individuals with PD, their families, health care resources and the community.

A number of previous studies suggest exercise capacity and exercise habits are positively correlated. In people with mild Parkinson's disease (Canning et al 2005), walking capacity, measured as distance walked in the 6-min walk test, correlated with the amount of walking (r=.64, p<0.01) performed each week. Similarly, in an earlier study of people with mild to moderate Parkinson's disease, regular exercise was associated with better exercise capacity (Canning et al 1997). It appears, therefore, that proactive intervention aimed at developing good exercise habits in sedentary individuals with early to mid-stage Parkinson's disease has the potential to reduce or delay walking difficulties.

This study aims to establish the efficacy of a home-based treadmill walking program in providing an early intervention which addresses the primary motor control impairment of hypokinesia, while at the same time maintaining or improving exercise capacity.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Home-based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-stage Parkinson's Disease?
Study Start Date : May 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treadmill training
Home-based treadmill training
Behavioral: Treadmill training
Walking on a treadmill 3 times per week for 6 weeks

No Intervention: Usual care
Control group

Primary Outcome Measures :
  1. Distance walked in 6 minutes [ Time Frame: study entry (0 weeks), 7 and 13 weeks ]

Secondary Outcome Measures :
  1. Unified Parkinson's disease Rating Scale (UPDRS) - motor examination [ Time Frame: 0, 7 and 13 weeks ]
  2. The Parkinson's disease Questionnaire (PDQ-39 [ Time Frame: 0, 7 and 13 weeks ]
  3. 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. [ Time Frame: 0, 7 and 13 weeks ]
  4. Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test. [ Time Frame: 0, 7 and 13 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00261781

Australia, New South Wales
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
Natalie Allen
South West Sydney Local Health District
Principal Investigator: Colleen G Canning, PhD University of Sydney

Publications of Results:
Other Publications:
Responsible Party: Natalie Allen, Dr Natalie allen, University of Sydney Identifier: NCT00261781     History of Changes
Other Study ID Numbers: U3189
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Natalie Allen, University of Sydney:
Quality of Life

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases