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Trial registered on ANZCTR
Registration number
ACTRN12612000567820
Ethics application status
Approved
Date submitted
24/05/2012
Date registered
28/05/2012
Date last updated
28/05/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of exercise on balance in newly diagnosed Transient Ischaemic Attack patients?
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Scientific title
The effect of exercise on balance in newly diagnosed Transient Ischaemic Attack patients?
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Secondary ID [1]
280549
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None
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Universal Trial Number (UTN)
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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:
Balance of patients diagnosed with a transient ischaemic attack
286547
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Condition category
Condition code
Stroke
286817
286817
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0
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Ischaemic
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Physical Medicine / Rehabilitation
286832
286832
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0
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Other physical medicine / rehabilitation
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Exercise Programme:
Participants randomized to the exercise programme will visit the Massey University recreation centre, twice a week, for 8 weeks to take part in a group focused exercise session. Each exercise session will last 90 mins, incorporating 30 mins of aerobic exercise (treadmill, cycle ergometer) and 60 mins of balance based exercises. The balance exercises will include resistance exercise, core-stability, control, postural exerices, flexibility etc. Participant’s progression will be monitored over the course of the programme. Heart rate, blood pressure and perceived exertion will be monitored at rest, during the session and following the session. The group exercises will be supervised by the principal investigator (lecturer in exercise prescription and 8 years expereince of working with patient populations) and postgraduate MSc research scholars who have more than three years of practical experience of working with patient populations.
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Intervention code [1]
284925
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Rehabilitation
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Intervention code [2]
284926
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Lifestyle
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Intervention code [3]
284927
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Prevention
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Comparator / control treatment
The control condition will complete identical assessment procedures as those randomized to the exercise programme. However, those randomized to the control condition at the completion of the baseline assessment will receive normal care during the 8 week exercise programme. No additional supportive strategies are implemented in the 8 weeks following the TIA for those randomized to the normal care condition. As such, normal care enables patients to visit their general practitioner, physiotherapists and hospital (i.e., for check-ups) as and when the patient feels that it is needed or requested.
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Control group
Active
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Outcomes
Primary outcome [1]
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Balance (postural sway) as monitored by a force platform
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Assessment method [1]
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Timepoint [1]
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Baseline + Post-intervention
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Secondary outcome [1]
297570
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Carotid Artery Stiffness - This will be obtained non-invasively using doppler ultrasound. The subject will be supine for 15 minutes prior to the assessment of carotid artery stiffness, and blood flow using ultrasound.
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Assessment method [1]
297570
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Timepoint [1]
297570
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Baseline + Post-intervention
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Secondary outcome [2]
297571
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Coronary artery disease risk factors - Following the completion of a health history questionnaire, participants will have a finger-prick capillary sample to enable the assessment of total cholesterol (TC), high-density lipoproteins (HDL), TC: HDL ratio, using a cardiochek, and blood glucose (using a glucometer). Participats, seated, standing and supine blood pressure will be recorded, a long with height, weight, body mass index and hip and waist girth. Participants family history of coronary heart disease, smoking status and physical activity participation will also be noted.
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Assessment method [2]
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Timepoint [2]
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Baseline + Post-intervention
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Secondary outcome [3]
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Fitness as determined by a resting and exercise ECG
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Assessment method [3]
297572
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Timepoint [3]
297572
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Baseline + Post-intervention
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Eligibility
Key inclusion criteria
Those diagnosed with TIA after review by a specialist stroke physician
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Minimum age
18
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
Oxygen dependence, uncontrolled angina, unstable cardiac conditions, uncontrolled diabetes mellitus, major medical conditions, claudication, febrile illness, significant cognitive impairment, immobile
TIA patients who reside outside of the Wellington Region (i.e., further away than Porirua).
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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)
The Stroke Department at Wellington Hospital receives referrals for all those with possible TIA in the Region. Referrals are received via telephone, fax or e-mail from General Practitioners, the Emergency Department and Paramedics. All referrals are reviewed within 2 working days by a specialist physician and appropriate diagnostic tests undertaken, as per the NZ TIA guidelines. Between 6 and 10 referrals are seen each week. Those in whom a diagnosis of TIA/Non-disabling stroke is reached will be invited to participate. Following the baseline assessments participants will be randomized to the exercise programme or to the control group. Randomization will the occur via 'allocation concealment'. Allocation concealment will occur via sealed opaque envelopes which will be sequentially numbered.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation The randomization sequence will be generated using the following internet source (http://www.randomizer.org/form.htm). The randomization sequence (i.e. A = Exercise; B = Control) will be placed in a sequentially numbered envelope (from 1-30) based on the derived sequence generated by the website
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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
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
Recruiting
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Date of first participant enrolment
Anticipated
14/05/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
4331
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New Zealand
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State/province [1]
4331
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Funding & Sponsors
Funding source category [1]
285316
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University
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Name [1]
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Massey University
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Address [1]
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63 Wallace St,
Wellington, 6021
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Country [1]
285316
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New Zealand
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Primary sponsor type
University
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Name
Massey University
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Address
63 Wallace St,
Wellington, 6021
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Country
New Zealand
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Wellington Regional Hospital
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Address [1]
284173
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Riddiford St, Wellington, 6021
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Country [1]
284173
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New Zealand
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Other collaborator category [1]
260821
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Individual
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Name [1]
260821
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Dr Kong Chung
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Address [1]
260821
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Wellington Regional Hospital, Riddiford Street, Wellington, 6021
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Country [1]
260821
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New Zealand
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Other collaborator category [2]
260822
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Individual
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Name [2]
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Mrs Lai-kin Wong
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Address [2]
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Wellington Regional Hospital, Riddiford Street, Wellington, 6021
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Country [2]
260822
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New Zealand
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Other collaborator category [3]
260823
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Individual
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Name [3]
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Mr Brandon Woolley
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Address [3]
260823
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Massey University, 63 Wallace St, Wellington, 6021
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Country [3]
260823
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New Zealand
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Other collaborator category [4]
260824
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Individual
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Name [4]
260824
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Dr Lee Stoner
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Address [4]
260824
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Massey University, 63 Wallace St, Wellington, 6021
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Country [4]
260824
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New Zealand
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Other collaborator category [5]
260825
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Individual
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Name [5]
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Dr Sally Lark
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Address [5]
260825
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Massey University, 63 Wallace St, Wellington, 6021
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Country [5]
260825
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New Zealand
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Other collaborator category [6]
260826
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Individual
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Name [6]
260826
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Dr Danielle Lambrick
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Address [6]
260826
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Massey University, 63 Wallace St, Wellington, 6021
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Country [6]
260826
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
287330
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Northern Regional Health and Disability Ethics Committee
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Ethics committee address [1]
287330
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Northern X Regional Ethics Committee
Private Bag 92522
Wellesley Street
Auckland 1141
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Ethics committee country [1]
287330
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New Zealand
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Date submitted for ethics approval [1]
287330
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Approval date [1]
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05/04/2012
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Ethics approval number [1]
287330
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NTX/12/02/009
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Summary
Brief summary
Recent research has demonstrated that balance and balance confidence is impaired after stroke, limiting independence in activities of daily living (i.e., cooking, shopping, walking, etc). When symptoms of stroke resolve within 24 hours it is known as a Transient Ischaemic Attack (TIA; ‘mini’ stroke). To date, research is yet to identify whether balance and/or balance confidence is impaired in patients following a TIA. Anecdotal evidence from the study CEN/10/10/046 revealed that balance may be impaired in TIA patients. TIA patients mentioned that they received substantial functional benefits from exercises aimed at improving balance after completing an 8 week exercise intervention. However, the degree to which a balance-based exercise intervention positively influences balance performance and confidence has not been established. Therefore, the purpose of this investigation is to identify whether balance is actually impaired in TIA patients. Previous research has demonstrated that balance training exercises improves balance performance and confidence after stroke. Providing balance impairments are found in TIA patients, this investigation also aims to identify the effects of a balance-based exercise intervention on balance performance and confidence.
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Trial website
N/A
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
34220
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Address
34220
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Country
34220
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Phone
34220
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Fax
34220
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Email
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Contact person for public queries
Name
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Dr James Faulkner
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Address
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Massey University
63 Wallace St
Wellington, 6021
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Country
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New Zealand
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Phone
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+64 (0)4 801 5799 ext 62104
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Fax
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Email
17467
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[email protected]
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Contact person for scientific queries
Name
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Dr James Faulkner
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Address
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Massey University
63 Wallace St
Wellington, 6021
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Country
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New Zealand
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Phone
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+64 (0)4 801 5799 ext 62104
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Fax
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Email
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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
Source
Title
Year of Publication
DOI
Embase
Effect of early exercise engagement on arterial stiffness in patients diagnosed with a transient ischaemic attack.
2015
https://dx.doi.org/10.1038/jhh.2014.56
N.B. These documents automatically identified may not have been verified by the study sponsor.
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