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

Primary Purpose

Idiopathic Parkinson's Disease

Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Treadmill training
Sponsored by
Natalie Allen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease focused on measuring Treadmill, Walking, Exercise, Automaticity, Quality of Life

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treadmill training

Usual care

Arm Description

Home-based treadmill training

Control group

Outcomes

Primary Outcome Measures

Distance walked in 6 minutes

Secondary Outcome Measures

Unified Parkinson's disease Rating Scale (UPDRS) - motor examination
The Parkinson's disease Questionnaire (PDQ-39
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.
Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.

Full Information

First Posted
December 1, 2005
Last Updated
May 27, 2015
Sponsor
Natalie Allen
Collaborators
South West Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT00261781
Brief Title
Walking Capacity in Parkinson's Disease (PD-Walk)
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
20 subjects completed for a pilot, further funding required to continue study
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Natalie Allen
Collaborators
South West Sydney Local Health District

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease
Keywords
Treadmill, Walking, Exercise, Automaticity, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill training
Arm Type
Experimental
Arm Description
Home-based treadmill training
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Behavioral
Intervention Name(s)
Treadmill training
Intervention Description
Walking on a treadmill 3 times per week for 6 weeks
Primary Outcome Measure Information:
Title
Distance walked in 6 minutes
Time Frame
study entry (0 weeks), 7 and 13 weeks
Secondary Outcome Measure Information:
Title
Unified Parkinson's disease Rating Scale (UPDRS) - motor examination
Time Frame
0, 7 and 13 weeks
Title
The Parkinson's disease Questionnaire (PDQ-39
Time Frame
0, 7 and 13 weeks
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen G Canning, PhD
Organizational Affiliation
University of Sydney
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
11322672
Citation
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.
Results Reference
background
PubMed Identifier
9041903
Citation
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.
Results Reference
background
PubMed Identifier
11322669
Citation
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.
Results Reference
background
PubMed Identifier
22257506
Citation
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.
Results Reference
result

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

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