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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
Scientific title
The effects of muscle power training compared with sham exercise training on leg muscle power in people with Parkinson’s disease
Secondary ID [1] 263044 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 270777 0
Condition category
Condition code
Neurological 270960 270960 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 270961 270961 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 269388 0
Treatment: Other
Intervention code [2] 269389 0
Rehabilitation
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.
Control group
Active

Outcomes
Primary outcome [1] 279627 0
Peak muscle power of the leg extensor, hip flexor, knee flexor and hip abductor muscles, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
Timepoint [1] 279627 0
At baseline and at one week after completion of intervention.
Secondary outcome [1] 294078 0
Global perceived effect of the participant's perception of the effect of the intervention, using a standard 10 point scale.
Timepoint [1] 294078 0
At 1 week after intervention
Secondary outcome [2] 294079 0
Comfortable and fast gait speed over 10 m.
Timepoint [2] 294079 0
At baseline and at 1 week after intervention.
Secondary outcome [3] 294080 0
Timed single leg stand up to 60 s.
Timepoint [3] 294080 0
At baseline and at 1 week after intervention.
Secondary outcome [4] 294081 0
Maximal anteroposterior balance range in mm, measured with a portable swaymeter.
Timepoint [4] 294081 0
At baseline and at 1 week after intervention.
Secondary outcome [5] 294082 0
Choice stepping reaction time, measured using a handheld stopwatch and a portable mat.
Timepoint [5] 294082 0
At baseline and at 1 week after intervention.
Secondary outcome [6] 294083 0
Velocity at peak power for the leg extensors, knee flexors, hip flexors and hip abductors, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
Timepoint [6] 294083 0
At baseline and at 1 week after intervention.
Secondary outcome [7] 294084 0
Rate of power production for the leg extensors, knee flexors, hip flexors and hip abductors, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
Timepoint [7] 294084 0
At baseline and at 1 week after intervention.
Secondary outcome [8] 294085 0
Maximal muscle strength of the leg extensors, knee flexors, hip flexors and hip abductors, measured using Keiser pneumatic variable resistance equipment (Fresno, CA).
Timepoint [8] 294085 0
At baseline and at 1 week after intervention.
Secondary outcome [9] 294086 0
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.
Timepoint [9] 294086 0
At baseline and at 1 week after intervention.
Secondary outcome [10] 294087 0
Number of falls, recorded using monthly falls diaries.
Timepoint [10] 294087 0
At 6 months after randomisation.
Secondary outcome [11] 299099 0
Time Up & Go test.
Timepoint [11] 299099 0
At baseline and at 1 week after intervention
Secondary outcome [12] 299100 0
New Freezing of Gait Questionnaire.
Timepoint [12] 299100 0
At baseline and at 1 week after intervention

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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini-mental state examination score < 24/30.
Other degenerative neurological conditions, eg, multiple sclerosis.
Unstable cardiovascular status.

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)
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.
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.
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2011
Actual
18/04/2011
Date of last participant enrolment
Anticipated
Actual
13/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4495 0
2141
Recruitment postcode(s) [2] 4496 0
2753
Recruitment postcode(s) [3] 4497 0
2768
Recruitment postcode(s) [4] 4498 0
2760
Recruitment postcode(s) [5] 4499 0
2117
Recruitment postcode(s) [6] 4500 0
2558
Recruitment postcode(s) [7] 4501 0
2227
Recruitment postcode(s) [8] 4502 0
2035
Recruitment postcode(s) [9] 4503 0
2170
Recruitment postcode(s) [10] 4504 0
2200
Recruitment postcode(s) [11] 4505 0
2022
Recruitment postcode(s) [12] 4506 0
2007
Recruitment postcode(s) [13] 4507 0
2095
Recruitment postcode(s) [14] 4508 0
2088
Recruitment postcode(s) [15] 4509 0
2067
Recruitment postcode(s) [16] 4510 0
2074
Recruitment postcode(s) [17] 4511 0
2154

Funding & Sponsors
Funding source category [1] 269856 0
Charities/Societies/Foundations
Name [1] 269856 0
Parkinson's NSW
Country [1] 269856 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
PO Box 170, Lidcombe NSW 1825.
Country
Australia
Secondary sponsor category [1] 268879 0
None
Name [1] 268879 0
Address [1] 268879 0
Country [1] 268879 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271828 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 271828 0
Level 6, Jane Foss Russell Building G02
The University of Sydney, NSW 2006.
Ethics committee country [1] 271828 0
Australia
Date submitted for ethics approval [1] 271828 0
Approval date [1] 271828 0
10/02/2011
Ethics approval number [1] 271828 0
13418.

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33159 0
A/Prof Colleen Canning
Address 33159 0
Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 33159 0
Australia
Phone 33159 0
+61 2 9351 9263
Fax 33159 0
Email 33159 0
[email protected]
Contact person for public queries
Name 16406 0
Ms Serene Paul
Address 16406 0
Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 16406 0
Australia
Phone 16406 0
+61 2 9351 9435
Fax 16406 0
+61 2 9351 9278
Email 16406 0
[email protected]
Contact person for scientific queries
Name 7334 0
Dr Colleen Canning
Address 7334 0
Physiotherapy, Faculty of Health Sciences
The University of Sydney
PO Box 170
Lidcombe NSW 1825
Country 7334 0
Australia
Phone 7334 0
+61 2 9351 9263
Fax 7334 0
+61 2 9351 9278
Email 7334 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

Documents added manually
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