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

This study has suspended participant recruitment.
(20 subjects completed for a pilot, further funding required to continue study)
Sponsor:
Collaborator:
South West Sydney Local Health District
Information provided by:
University of Sydney
ClinicalTrials.gov Identifier:
NCT00261781
First received: December 1, 2005
Last updated: July 1, 2008
Last verified: June 2008

December 1, 2005
July 1, 2008
May 2005
December 2009   (final data collection date for primary outcome measure)
Distance walked in 6 minutes [ Time Frame: study entry (0 weeks), 7 and 13 weeks ] [ Designated as safety issue: No ]
Distance walked in 6 minutes at study entry (0 weeks), 7 and 13 weeks
Complete list of historical versions of study NCT00261781 on ClinicalTrials.gov Archive Site
  • Unified Parkinson's disease Rating Scale (UPDRS) - motor examination [ Time Frame: 0, 7 and 13 weeks ] [ Designated as safety issue: No ]
  • The Parkinson's disease Questionnaire (PDQ-39 [ Time Frame: 0, 7 and 13 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Unified Parkinson's disease Rating Scale (UPDRS) - motor examination at 0, 7 and 13 weeks
  • The Parkinson's disease Questionnaire (PDQ-39) at 0, 7 and 13 weeks
  • Walking Automaticity at 0, 7 and 13 weeks, 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.
  • Walking consistency at 0, 7 and 13 weeks determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.
Not Provided
Not Provided
 
Walking Capacity in Parkinson's Disease (PD-Walk)
Does Home-Based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-Stage Parkinson's Disease?

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Parkinson's Disease
Behavioral: Treadmill training
Walking on a treadmill 3 times per week for 6 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
140
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
30 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00261781
U3189
No
Dr Colleen Canning, The University of Sydney
University of Sydney
South West Sydney Local Health District
Principal Investigator: Colleen G Canning, PhD University of Sydney
University of Sydney
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP