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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00261781




Registration number
NCT00261781
Ethics application status
Date submitted
1/12/2005
Date registered
5/12/2005
Date last updated
29/05/2015

Titles & IDs
Public title
Walking Capacity in Parkinson's Disease (PD-Walk)
Scientific title
Does Home-based Treadmill Training Improve Walking Capacity and Quality of Life in People With Early to Mid-stage Parkinson's Disease?
Secondary ID [1] 0 0
U3189
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Parkinson's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Treadmill training

Experimental: Treadmill training - Home-based treadmill training

No Intervention: Usual care - Control group


Behaviour: Treadmill training
Walking on a treadmill 3 times per week for 6 weeks
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Distance walked in 6 minutes
Timepoint [1] 0 0
study entry (0 weeks), 7 and 13 weeks
Secondary outcome [1] 0 0
Unified Parkinson's disease Rating Scale (UPDRS) - motor examination
Timepoint [1] 0 0
0, 7 and 13 weeks
Secondary outcome [2] 0 0
The Parkinson's disease Questionnaire (PDQ-39
Timepoint [2] 0 0
0, 7 and 13 weeks
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
0, 7 and 13 weeks
Secondary outcome [4] 0 0
Walking consistency determined as the co-efficients of variation for stride time and stride length recorded during the 6 minute walk test.
Timepoint [4] 0 0
0, 7 and 13 weeks

Eligibility
Key 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
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Natalie Allen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
South West Sydney Local Health District
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT00261781
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Colleen G Canning, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00261781