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Trial registered on ANZCTR


Registration number
ACTRN12607000193471
Ethics application status
Approved
Date submitted
23/03/2007
Date registered
3/04/2007
Date last updated
5/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can support group-based exercise reduce risk factors for falling in people with Parkinson's disease?
Scientific title
Can support group-based exercise reduce risk factors for falling in people with Parkinson's disease?
Universal Trial Number (UTN)
Trial acronym
STABLE GROUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 1711 0
Condition category
Condition code
Neurological 1804 1804 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Group
The exercise group will perform a 40-60 minute program of leg strengthening and balance exercises three times per week for 6 months. Participants will attend a monthly exercise class conducted by a physiotherapist in association with their Parkinson's NSW Support Group, as well as perform the exercises at home. Resistance for the strengthening exercises will be applied using weighted vests. Cueing strategies will be used to assist patients to manage freezing. Participants will also receive advice on falls prevention and a falls diary for recording any falls.
Intervention code [1] 1566 0
Rehabilitation
Comparator / control treatment
Control Group
The control group will receive advice on falls prevention and a falls diary for recording any falls.
Control group
Active

Outcomes
Primary outcome [1] 2524 0
Parkinson's disease falls risk score. Falls risk status will be determined using a recently validated Parkinson's disease-specific algorithm.
Timepoint [1] 2524 0
Assessed within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [1] 4361 0
1. Balance in standing will be measured with the Maximal Balance Range in Standing test and the Co-ordinated Stability in Standing tests. The step test component from the Berg Balance Scale will be performed and timed.
Timepoint [1] 4361 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [2] 4362 0
2. Knee extension (quadriceps) muscle strength will be measured using a spring gauge.
Timepoint [2] 4362 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [3] 4363 0
3. Freezing will be measured using the Freezing of Gait Questionnaire.
Timepoint [3] 4363 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [4] 4364 0
4. The Short Physical Performance Battery will be used to assess walking, balanced standing and sit to stand. Each component will be timed to allow analysis of individual components as well as the overall score.
Timepoint [4] 4364 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [5] 4365 0
5. Fear of falling will be measured with the Falls Efficacy Scale International.
Timepoint [5] 4365 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [6] 4366 0
6. Habitual activity levels will be assessed with a physical activity questionnaire.
Timepoint [6] 4366 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [7] 4367 0
7. Quality of life will be measured using the Parkinson's disease Questionnaire-39.
Timepoint [7] 4367 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [8] 4368 0
8. The number of falls per participant will be recorded over the 6 month study period using a falls diary.
Timepoint [8] 4368 0
Measured within 3 weeks prior to randomisation and within 3 weeks of 6 months after randomisation.
Secondary outcome [9] 4369 0
9. The method of exercise delivery will be evaluated using a questionnaire.
Timepoint [9] 4369 0
Exercise group only after 6 month intervention period.

Eligibility
Key inclusion criteria
1. Idiopathic Parkinson's disease2. Able to walk independently (with or without a walking aid)3. Fallen at least once in the last year OR is at risk of falling on assessment. 4. Parkinson's disease medication stable.
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dizziness or blackouts2. Angina in the last 12 months3. Heart attack, angioplasty or heart surgery in the last 12 months4. Other neurological / musculoskeletal / cardiopulmonary / metabolic / psychological conditions that would interfere with the safe conduct of the training and testing protocol5. Significant cognitive impairment (mini mental state exam <24).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Block randomisation will be used to allocate participants to treatment groups. All participants from the same support group will be allocated in equal numbers to treatment and control groups at the same time. Randomisation will be done by someone not involved in subject recruitment or assessment and will occur off site at a central location. By allocating all participants from one group together at a central location, recruitment staff will be unable to predict any participant's group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer will be used to generate a randomization table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Researchers involved in measurement (except for recording frequency of falls) will remain blind to group allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1958 0
Charities/Societies/Foundations
Name [1] 1958 0
Parkinson's NSW
Country [1] 1958 0
Australia
Funding source category [2] 2829 0
Charities/Societies/Foundations
Name [2] 2829 0
Physiotherapy Research Foundation
Country [2] 2829 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
PO BOX 170
Lidcombe NSW
1825
Country
Australia
Secondary sponsor category [1] 1768 0
None
Name [1] 1768 0
nil
Address [1] 1768 0
Country [1] 1768 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3654 0
The University of Sydney
Ethics committee address [1] 3654 0
Ethics committee country [1] 3654 0
Australia
Date submitted for ethics approval [1] 3654 0
Approval date [1] 3654 0
20/02/2007
Ethics approval number [1] 3654 0
02-2007/9676

Summary
Brief summary
Despite optimal medication, people with Parkinson's disease living in the community experience frequent and recurrent falls. These falls result in major adverse consequences both personally and economically for the person with Parkinson's disease and their families. Poor balance, reduced leg muscle strength and and freezing of gait have been found to be independent predictors for falls in people with Parkinson's disease.

This randomised controlled trial aims to determine the effect of a 6 month support-group based exercise program on falls risk as well as balance, lower limb muscle strength and freezing of gait in people with Parkinson's disease who are falling or at risk of falling.

Any reduction in falls rates has the potential to improve the quality of life of individuals with Parkinson's disease and their families as well as reduce the financial costs to them and the health care system.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27500 0
Address 27500 0
Country 27500 0
Phone 27500 0
Fax 27500 0
Email 27500 0
Contact person for public queries
Name 10755 0
Natalie Allen
Address 10755 0
Department of Neurology
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 10755 0
Australia
Phone 10755 0
+61 2 98455538
Fax 10755 0
Email 10755 0
[email protected]
Contact person for scientific queries
Name 1683 0
Dr Colleen Canning
Address 1683 0
School of Physiotherapy
Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 1683 0
Australia
Phone 1683 0
+61 2 93519263
Fax 1683 0
Email 1683 0
[email protected]

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

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