Walking Capacity in Parkinson's Disease (PD-Walk)
| Tracking Information | |||||
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| First Received Date ICMJE | December 1, 2005 | ||||
| Last Updated Date | July 1, 2008 | ||||
| Start Date ICMJE | May 2005 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Distance walked in 6 minutes [ Time Frame: study entry (0 weeks), 7 and 13 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Distance walked in 6 minutes at study entry (0 weeks), 7 and 13 weeks | ||||
| Change History | Complete list of historical versions of study NCT00261781 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Walking Capacity in Parkinson's Disease (PD-Walk) | ||||
| Official Title ICMJE | Does Home-Based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-Stage Parkinson's Disease? | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Idiopathic Parkinson's Disease | ||||
| Intervention ICMJE | Behavioral: Treadmill training
Walking on a treadmill 3 times per week for 6 weeks |
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| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | December 2009 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 30 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Australia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00261781 | ||||
| Other Study ID Numbers ICMJE | U3189 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr Colleen Canning, The University of Sydney | ||||
| Study Sponsor ICMJE | University of Sydney | ||||
| Collaborators ICMJE | South West Sydney Local Health District | ||||
| Investigators ICMJE |
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| Information Provided By | University of Sydney | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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