Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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