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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
BEHAVIORAL - Treadmill training

Experimental: Treadmill training - Home-based treadmill training

No intervention: Usual care - Control group


BEHAVIORAL: Treadmill training
Walking on a treadmill 3 times per week for 6 weeks
Intervention code [1] 0 0
BEHAVIORAL
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Canning CG, Allen NE, Dean CM, Goh L, Fung VS. Hom... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00261781