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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Does Home-based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-stage Parkinson's Disease?

Conditions
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Idiopathic Parkinson's Disease

Intervention / Treatment
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* Behavioral: Treadmill training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill training<br>Home-based treadmill training | Behavioral: Treadmill training<br>* Walking on a treadmill 3 times per week for 6 weeks<br>|
| No Intervention: Usual care<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance walked in 6 minutes |  | study entry (0 weeks), 7 and 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treadmill, Walking, Exercise, Automaticity, Quality of Life