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Trial registered on ANZCTR
Registration number
ACTRN12618000018213
Ethics application status
Approved
Date submitted
12/12/2017
Date registered
11/01/2018
Date last updated
11/01/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Electrical stimulation-muscle strength training in people with spinal cord injury
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Scientific title
Can high-intensity Neuromuscular electrical stimulation (NMES) strength training improve muscle strength and mass, physical health and quality of life in people with spinal cord injury?
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Secondary ID [1]
293592
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None
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Universal Trial Number (UTN)
U1111-1206-5386
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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:
spinal cord injury
305844
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Condition category
Condition code
Neurological
305054
305054
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0
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Other neurological disorders
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Injuries and Accidents
305055
305055
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
NMES was delivered by a high-voltage constant-current electrical stimulator (400 V, DS7A, Digitimer Ltd., Welwyn Garden City, UK) under the same conditions as the assessment through four self-adhesive stimulation electrodes (Axelgaard, PALS, USA) placed over the rectus femoris (RF), vastus lateralis (VL), and vastus medialis (VM). Two 5×10 cm electrodes were placed over RF and one 5×5 electrode was placed on each of the VM and VL approximately at their motor points using a split end cable, to increase the surface area of stimulation. The electrodes were placed to elicit the greatest twitch response with a low stimulation intensity.
Each session commenced with a “warm-up” period consisting of paired electrical square-wave stimuli (two 1000 µs square-wave pulses, 5–ms interpulse interval) followed by a maximum of three tetanic trains (tau-t,40mA) delivered to each leg separately every 20 s while the stimulation current was increased from 30 mA in 10-mA increments until a plateau in the maximum peak twitch torque was observed or the maximal current intensity was 99 mA. This plateau was defined as the maximal peak twitch torque (tau-tw,p) and was used as the target torque during the training session. Subsequently, a tetanic train of NMES at 40 mA (tau-t,40mA) was delivered followed by a maximum of three trains of NMES performed at different stimulation current intensities until reaching the closest value to the target torque.
After the warm-up period the NMES session commenced with electrically-evoked muscle contractions being elicited at the target torque for 5 sets of 10 repetitions on each leg, with a 1-min rest between sets. To determine the actual training intensity either one of two methods was used. The first method was by evoking the maximal peak twitch torque (tau-tw,p) and setting the current so the tetanic torque was equal to tau-tw,p. However, if tau-tw,p showed a decrease compared to previous sessions, a second method was used whereby the starting current was set to be equal to the highest current used in the previous training session. Within each session, the current was increased by 2 mA per each set of 10 repetitions to maintain a high torque production as fatigue developed; thus, if the second method was chosen, the current selected for set 1 was the same as that used in the final set of the previous session. Using this method, the torque produced in set 1 of training was always higher than that performed in any set of the previous session, so the evoked torque increased incrementally.
All training sessions were conducted by the same trained researcher, who was a senior Physiotherapist and were additional to any other rehabilitation exercise. The participants were asked to keep their physical training routine consistent for the duration of the experiment.
Training was performed twice a week (with at least one rest day between) for 12 weeks. All assessments were completed at -1 weeks (“Control period”), 0 weeks (0-wk) and 12 weeks (12-wk), except for resting blood samples which were taken at 0-wk and 12-wk only. Post-training assessments were taken 4-6 days after the last training session to allow for recovery of acute, residual effects of intense exercise. The procedures used in this study were similar from the methodology used in a previous study in people with spinal cord injury (SCI).
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Intervention code [1]
299845
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Treatment: Devices
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Knee-extension torque measurements using an isokinetic dynamometer (Biodex System 3 Pro Ronkonkoma, NY).
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Assessment method [1]
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Timepoint [1]
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At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk)
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Primary outcome [2]
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Muscle cross-sectional area of quadriceps femoris (CSA-QF) using B-mode axial-plane ultrasonography (Aloka SSD-a10, software number 6.1.09, Aloka Co., Ltd., Tokyo, Japan).
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Assessment method [2]
304217
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Timepoint [2]
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At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk)
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Primary outcome [3]
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Blood biomarkers for blood lipid profile.
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Assessment method [3]
304218
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Timepoint [3]
304218
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At baseline (0-wk) and 4-6 days after the last training session (12-wk)
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Secondary outcome [1]
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Spasticity measure using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET)
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Assessment method [1]
341275
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Timepoint [1]
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At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk)
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Secondary outcome [2]
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Blood biomarkers: C-reactive protein (CRP) concentration.
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Assessment method [2]
341531
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Timepoint [2]
341531
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At baseline (0-wk) and 4-6 days after the last training session (12-wk)
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Secondary outcome [3]
341532
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Quality of life measure (QoL) using the Quality of life Index (QLI) for people with spinal cord injuries (SCI).
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Assessment method [3]
341532
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Timepoint [3]
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At pre-baseline (-1 wk, control period), baseline (0-wk) and 4-6 days after the last training session (12-wk).
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Eligibility
Key inclusion criteria
Inclusion criteria: age 18-65 years; SCI longer than 6 months that led to complete or incomplete paraplegia or tetraplegia; level of injury between C2 and L5; AIS (American Spinal Cord Injury Association Impairment Scale) A, B, C or D; have medical permission to enrol in an intensive exercise program; and able to participate in the program over a 14-week period.
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Minimum age
18
Years
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Maximum age
65
Years
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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
Acute phase of injury (less than 6 months from injury); ventilator dependent, other associated neurological disease; and complications such as severe urinary infection, pressure ulcers, previous lower-limb fractures or any other health condition that may constrain the participation in an exercise program.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Wilcoxon non-parametric tests were used to compare changes in control and experimental periods (-1, 0 and 12-weeks) in peak twitch torque (tau-tw,p), evoked tetanic torque (tau-t,40mA), cross-sectional area (CSA), body composition, biochemical measures for lipid profile and CRP, symptoms of spasticity and QoL outcomes. Reliability of the outcome measures between the control period (-1-wk) and 0-wk was assessed using the intra-class correlation coefficient (ICC). Statistical significance was set at an alpha level of equals or less than 0.05 and values are reported as mean and SD.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
1/07/2015
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Date of last participant enrolment
Anticipated
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Actual
15/03/2016
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Date of last data collection
Anticipated
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Actual
1/08/2016
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Sample size
Target
10
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
298209
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University
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Name [1]
298209
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Edith Cowan University
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Address [1]
298209
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270 Joondalup drive. Joondalup. Western Australia (6027).
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Country [1]
298209
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Australia
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Primary sponsor type
Individual
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Name
Vanesa Bochkezanian
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Address
Central Queensland University. Bruce Highway, North Rockhampton, Queensland, Australia (4702)
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Country
Australia
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Secondary sponsor category [1]
297308
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Charities/Societies/Foundations
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Name [1]
297308
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Spinal Cord Injuries Australia
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Address [1]
297308
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1 Jennifer St, Little Bay, NSW, Australia (2036).
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Country [1]
297308
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Australia
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Secondary sponsor category [2]
297311
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Individual
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Name [2]
297311
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Anthony J Blazevich
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Address [2]
297311
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Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
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Country [2]
297311
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Australia
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Secondary sponsor category [3]
297312
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Individual
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Name [3]
297312
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Robert U Newton
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Address [3]
297312
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Edith Cowan University, 270 Joondalup drive, Joondalup, Western Australia (6027).
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Country [3]
297312
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299216
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Edith Cowan University Research Ethics Commitee
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Ethics committee address [1]
299216
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Edith Cowan University Ethics Committee. 270 Joondalup drive. Joondalup, Western Australia (6027)
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Ethics committee country [1]
299216
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Australia
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Date submitted for ethics approval [1]
299216
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14/01/2015
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Approval date [1]
299216
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27/01/2015
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Ethics approval number [1]
299216
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11623
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Summary
Brief summary
Background: Muscle force production is usually impaired in people with spinal cord injury (SCI). However, the use of high-intensity NMES strength training can help promote metabolically active lean muscle mass and thus, increase muscle mass and provide physical health and quality of life (QoL) benefits. Nonetheless, NMES is usually used at low-stimulation intensities (e.g. functional electrical stimulation) and there is limited evidence regarding the effects of high-intensity NMES strength training for increasing muscle force capacity and mass, ameliorating symptoms of spasticity or improving physical health markers and quality of life (QoL) in people with SCI.
The primary purpose of this study was to investigate the effects of electrical stimulation of the thigh muscles using pads into improving the muscle size, muscle force, physical health, symptoms of spasms in the muscles and well-being in people who suffered from an accident and their legs are paralysed. The study hypotheses was that 12-weeks of electrical stimulation used as a muscle strength tool will improve muscle mass, muscle size, physical health, symptoms of spasms in the muscles and well-being in people who suffered from an accident and their legs are paralysed.
Methods: Five individuals with SCI completed five 10-repetition sets of high-intensity isometric knee extension NMES strength training sessions for 12 weeks in both right (R) and left (L) quadriceps muscles. Quadriceps femoris isometric knee extensor torque was measured on a dynamometer and cross-sectional area (CSA- quadriceps femoris (QF)) were measured with extended-field-of-view ultrasonography. Venous blood samples were collected for blood lipid profiling and c-reactive protein (CRP) analyses. The Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) was used to assess symptoms of spasticity and the quality of life index (QLI) SCI version III was used for QoL measures.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
2263
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/AnzctrAttachments/374158-March Information letter S4 VB.docx
(Participant information/consent)
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Contacts
Principal investigator
Name
79690
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Dr Vanesa Bochkezanian
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Address
79690
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Central Queensland University. Bruce Highway. North Rockhampton. QLD. Australia (4702)
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Country
79690
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Australia
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Phone
79690
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+61 7 49306453
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Fax
79690
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Email
79690
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[email protected]
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Contact person for public queries
Name
79691
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Dr Vanesa Bochkezanian
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Address
79691
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Central Queensland University. Bruce Highway. North Rockhampton. QLD. Australia (4702)
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Country
79691
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Australia
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Phone
79691
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+61 7 49306453
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Fax
79691
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Email
79691
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[email protected]
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Contact person for scientific queries
Name
79692
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Prof Anthony J Blazevich
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Address
79692
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Edith Cowan University, 270 Joondalup drive. Joondalup, Western Australia (6027).
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Country
79692
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Australia
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Phone
79692
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+61 8 63045472
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Fax
79692
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Email
79692
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[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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