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Trial registered on ANZCTR
Registration number
ACTRN12611000986976
Ethics application status
Approved
Date submitted
15/09/2011
Date registered
15/09/2011
Date last updated
8/04/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Muscle power training in Parkinson’s disease
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Scientific title
The effects of muscle power training compared with sham exercise training on leg muscle power in people with Parkinson’s disease
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Secondary ID [1]
263044
0
Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease
270777
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Condition category
Condition code
Neurological
270960
270960
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0
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Parkinson's disease
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Physical Medicine / Rehabilitation
270961
270961
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Muscle power training of the leg extensors, knee flexors, hip flexors and hip abductors twice a week for 3 months. These exercises will be performed on Keiser pneumatic variable resistance equipment (Fresno, CA), specifically on the seated leg press, seated leg curl and standing hip machines. The training will comprise 3 sets of 8 repetitions, with training loads of 40% 1RM for the 1st set, 50% 1RM for the 2nd set and 60% 1RM for the 3rd set. When participants are able to perform 10 repetitions of the final set, their training load will be increased by 5% for the next training session. Participants will perform the concentric component of each exercise as fast as possible. Participants will train in pairs under full supervision of a physiotherapist in a university laboratory. Participants will take turns to complete each set, providing encouragement for their training partner while physically resting in order to maximise the benefits of observational learning. The entire session will last approximately 1 hour, commencing with a warm-up of 4 slow repetitions at 20% 1RM for each exercise, and cooling down by marching on the spot for up to 30 seconds after each exercise.
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Intervention code [1]
269388
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Treatment: Other
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Intervention code [2]
269389
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Rehabilitation
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Comparator / control treatment
Homebased flexibility exercises for the leg flexors and extensors, hip abductors, trunk flexors and trunk rotators. Participants will receive a home visit from a physiotherapist to set them up with their exercises, and subsequently they will perform the exercises twice a week on their own for 3 months. Participants will keep a written record of exercises completed and will be telephoned once a fortnight to monitor progress and provide encouragement. The home exercises will comprise 2 sets of each exercise, with 8 repetitions per set for the 1st month, 10 repetitions per set for the 2nd month, and 12 repetitions per set for the 3rd month.
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Control group
Active
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Outcomes
Primary outcome [1]
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Peak muscle power of the leg extensor, hip flexor, knee flexor and hip abductor muscles, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
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Assessment method [1]
279627
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Timepoint [1]
279627
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At baseline and at one week after completion of intervention.
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Secondary outcome [1]
294078
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Global perceived effect of the participant's perception of the effect of the intervention, using a standard 10 point scale.
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Assessment method [1]
294078
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Timepoint [1]
294078
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At 1 week after intervention
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Secondary outcome [2]
294079
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Comfortable and fast gait speed over 10 m.
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Assessment method [2]
294079
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Timepoint [2]
294079
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At baseline and at 1 week after intervention.
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Secondary outcome [3]
294080
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Timed single leg stand up to 60 s.
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Assessment method [3]
294080
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Timepoint [3]
294080
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At baseline and at 1 week after intervention.
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Secondary outcome [4]
294081
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Maximal anteroposterior balance range in mm, measured with a portable swaymeter.
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Assessment method [4]
294081
0
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Timepoint [4]
294081
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At baseline and at 1 week after intervention.
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Secondary outcome [5]
294082
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Choice stepping reaction time, measured using a handheld stopwatch and a portable mat.
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Assessment method [5]
294082
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Timepoint [5]
294082
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At baseline and at 1 week after intervention.
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Secondary outcome [6]
294083
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Velocity at peak power for the leg extensors, knee flexors, hip flexors and hip abductors, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
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Assessment method [6]
294083
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Timepoint [6]
294083
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At baseline and at 1 week after intervention.
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Secondary outcome [7]
294084
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Rate of power production for the leg extensors, knee flexors, hip flexors and hip abductors, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
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Assessment method [7]
294084
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Timepoint [7]
294084
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At baseline and at 1 week after intervention.
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Secondary outcome [8]
294085
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Maximal muscle strength of the leg extensors, knee flexors, hip flexors and hip abductors, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
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Assessment method [8]
294085
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Timepoint [8]
294085
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At baseline and at 1 week after intervention.
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Secondary outcome [9]
294086
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Peak muscle power and maximal muscle strength of the elbow extensor and shoulder flexor muscles of each arm, measured using Keiser pneumatic variable resistance equipment.
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Assessment method [9]
294086
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Timepoint [9]
294086
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At baseline and at 1 week after intervention.
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Secondary outcome [10]
294087
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Number of falls, recorded using monthly falls diaries.
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Assessment method [10]
294087
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Timepoint [10]
294087
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At 6 months after randomisation.
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Secondary outcome [11]
299099
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Time Up & Go test.
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Assessment method [11]
299099
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Timepoint [11]
299099
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At baseline and at 1 week after intervention
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Secondary outcome [12]
299100
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New Freezing of Gait Questionnaire.
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Assessment method [12]
299100
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Timepoint [12]
299100
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At baseline and at 1 week after intervention
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Eligibility
Key inclusion criteria
Diagnosis of idiopathic Parkinson’s disease.
Living in the community.
Able to walk 50 m independently with or without a walking aid.
Stable PD medications for at least 2 weeks.
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Mini-mental state examination score < 24/30.
Other degenerative neurological conditions, eg, multiple sclerosis.
Unstable cardiovascular status.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants are screened and if they meet the eligibility criteria and agree to participate, they enrol in the study by undergoing baseline assessment. Block randomisation will then be used to allocate participants to treatment groups. Randomisation will be done by someone not involved in subject recruitment or assessment and will occur off site at a central location.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation table will be generated by the Random number function in Excel.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
18/04/2011
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Actual
18/04/2011
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Date of last participant enrolment
Anticipated
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Actual
13/07/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
36
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
4495
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2141
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Recruitment postcode(s) [2]
4496
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2753
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Recruitment postcode(s) [3]
4497
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2768
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Recruitment postcode(s) [4]
4498
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2760
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Recruitment postcode(s) [5]
4499
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2117
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Recruitment postcode(s) [6]
4500
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2558
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Recruitment postcode(s) [7]
4501
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2227
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Recruitment postcode(s) [8]
4502
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2035
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Recruitment postcode(s) [9]
4503
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2170
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Recruitment postcode(s) [10]
4504
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2200
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Recruitment postcode(s) [11]
4505
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2022
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Recruitment postcode(s) [12]
4506
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2007
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Recruitment postcode(s) [13]
4507
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2095
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Recruitment postcode(s) [14]
4508
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2088
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Recruitment postcode(s) [15]
4509
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2067
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Recruitment postcode(s) [16]
4510
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2074
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Recruitment postcode(s) [17]
4511
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2154
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Funding & Sponsors
Funding source category [1]
269856
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Charities/Societies/Foundations
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Name [1]
269856
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Parkinson's NSW
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Address [1]
269856
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PO Box 71, North Ryde BC NSW 1670.
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Country [1]
269856
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
PO Box 170, Lidcombe NSW 1825.
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Country
Australia
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Secondary sponsor category [1]
268879
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None
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Name [1]
268879
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Address [1]
268879
0
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Country [1]
268879
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
271828
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University of Sydney Human Research Ethics Committee
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Ethics committee address [1]
271828
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Level 6, Jane Foss Russell Building G02
The University of Sydney, NSW 2006.
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Ethics committee country [1]
271828
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Australia
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Date submitted for ethics approval [1]
271828
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Approval date [1]
271828
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10/02/2011
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Ethics approval number [1]
271828
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13418.
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Summary
Brief summary
Muscle power is reduced in people with Parkinson’s disease and is associated with reduced walking speed and falls. The aim of this randomised controlled trial is to determine whether the benefits of muscle power training on walking speed and balance demonstrated in the older general population can be gained by people with Parkinson’s disease. Muscle power training deliberately targets the fundamental problem of slowness of movement, making evaluation of the effect of this training an urgent research priority with potential to improve walking and balance in people with Parkinson's disease as well as provide insights into mechanisms underlying effects.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Colleen Canning
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Address
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Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
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Country
33159
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Australia
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Phone
33159
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+61 2 9351 9263
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Fax
33159
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Email
33159
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[email protected]
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Contact person for public queries
Name
16406
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Ms Ms Serene Paul
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Address
16406
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Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
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Country
16406
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Australia
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Phone
16406
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+61 2 9351 9435
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Fax
16406
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+61 2 9351 9278
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Email
16406
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[email protected]
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Contact person for scientific queries
Name
7334
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A/Prof Dr Colleen Canning
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Address
7334
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Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
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Country
7334
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Australia
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Phone
7334
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+61 2 9351 9263
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Fax
7334
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+61 2 9351 9278
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Email
7334
0
[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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