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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?
Scientific title
The effect of exercise on balance in newly diagnosed Transient Ischaemic Attack patients?
Secondary ID [1] 280549 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Balance of patients diagnosed with a transient ischaemic attack 286547 0
Condition category
Condition code
Stroke 286817 286817 0 0
Ischaemic
Physical Medicine / Rehabilitation 286832 286832 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 284925 0
Rehabilitation
Intervention code [2] 284926 0
Lifestyle
Intervention code [3] 284927 0
Prevention
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.
Control group
Active

Outcomes
Primary outcome [1] 287184 0
Balance (postural sway) as monitored by a force platform
Timepoint [1] 287184 0
Baseline + Post-intervention
Secondary outcome [1] 297570 0
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.
Timepoint [1] 297570 0
Baseline + Post-intervention
Secondary outcome [2] 297571 0
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.
Timepoint [2] 297571 0
Baseline + Post-intervention
Secondary outcome [3] 297572 0
Fitness as determined by a resting and exercise ECG
Timepoint [3] 297572 0
Baseline + Post-intervention

Eligibility
Key inclusion criteria
Those diagnosed with TIA after review by a specialist stroke physician
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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).

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)
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.
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4331 0
New Zealand
State/province [1] 4331 0

Funding & Sponsors
Funding source category [1] 285316 0
University
Name [1] 285316 0
Massey University
Address [1] 285316 0
63 Wallace St,
Wellington, 6021
Country [1] 285316 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
63 Wallace St,
Wellington, 6021
Country
New Zealand
Secondary sponsor category [1] 284173 0
Hospital
Name [1] 284173 0
Wellington Regional Hospital
Address [1] 284173 0
Riddiford St, Wellington, 6021
Country [1] 284173 0
New Zealand
Other collaborator category [1] 260821 0
Individual
Name [1] 260821 0
Dr Kong Chung
Address [1] 260821 0
Wellington Regional Hospital, Riddiford Street, Wellington, 6021
Country [1] 260821 0
New Zealand
Other collaborator category [2] 260822 0
Individual
Name [2] 260822 0
Mrs Lai-kin Wong
Address [2] 260822 0
Wellington Regional Hospital, Riddiford Street, Wellington, 6021
Country [2] 260822 0
New Zealand
Other collaborator category [3] 260823 0
Individual
Name [3] 260823 0
Mr Brandon Woolley
Address [3] 260823 0
Massey University, 63 Wallace St, Wellington, 6021
Country [3] 260823 0
New Zealand
Other collaborator category [4] 260824 0
Individual
Name [4] 260824 0
Dr Lee Stoner
Address [4] 260824 0
Massey University, 63 Wallace St, Wellington, 6021
Country [4] 260824 0
New Zealand
Other collaborator category [5] 260825 0
Individual
Name [5] 260825 0
Dr Sally Lark
Address [5] 260825 0
Massey University, 63 Wallace St, Wellington, 6021
Country [5] 260825 0
New Zealand
Other collaborator category [6] 260826 0
Individual
Name [6] 260826 0
Dr Danielle Lambrick
Address [6] 260826 0
Massey University, 63 Wallace St, Wellington, 6021
Country [6] 260826 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287330 0
Northern Regional Health and Disability Ethics Committee
Ethics committee address [1] 287330 0
Northern X Regional Ethics Committee
Private Bag 92522
Wellesley Street
Auckland 1141
Ethics committee country [1] 287330 0
New Zealand
Date submitted for ethics approval [1] 287330 0
Approval date [1] 287330 0
05/04/2012
Ethics approval number [1] 287330 0
NTX/12/02/009

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.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34220 0
Address 34220 0
Country 34220 0
Phone 34220 0
Fax 34220 0
Email 34220 0
Contact person for public queries
Name 17467 0
Dr James Faulkner
Address 17467 0
Massey University
63 Wallace St
Wellington, 6021
Country 17467 0
New Zealand
Phone 17467 0
+64 (0)4 801 5799 ext 62104
Fax 17467 0
Email 17467 0
J.Faulkner@massey.ac.nz
Contact person for scientific queries
Name 8395 0
Dr James Faulkner
Address 8395 0
Massey University
63 Wallace St
Wellington, 6021
Country 8395 0
New Zealand
Phone 8395 0
+64 (0)4 801 5799 ext 62104
Fax 8395 0
Email 8395 0
J.Faulkner@massey.ac.nz

No information has been provided regarding IPD availability
Summary results
No Results