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Trial registered on ANZCTR


Registration number
ACTRN12613000869774
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
6/08/2013
Date last updated
27/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of early exercise engagement on cardiovascular and cerebrovascular health in stroke and high risk transient ischeamic attack (TIA) patients: a pilot study
Scientific title
Effect of early exercise engagement on cardiovascular and cerebrovascular health in stroke and high risk TIA patients: a pilot study
Secondary ID [1] 282934 0
Nil Known
Universal Trial Number (UTN)
U111111424115
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High risk TIA

289749 0
stroke patients 289750 0
Condition category
Condition code
Stroke 290086 290086 0 0
Ischaemic
Physical Medicine / Rehabilitation 290087 290087 0 0
Other physical medicine / rehabilitation
Cardiovascular 290124 290124 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study intends to examine the effect of early exercise engagement on various cardiovascular, cerebrovascular
and psychosocial outcome measures in high risk TIA patients and ischaemic stroke patients.

Participants randomized to the early or delayed exercise conditions will visit the Massey University recreation centre, twice a week, for 12 weeks to take part in a group focused exercise session. Those individuals randomized to the early exercise programme will commence their exercise sessions within 7 days of TIA or stroke diagnosis. Those randomized to the delayed exercise programme will commence their exercise sessions 28 days after TIA or stroke diagnosis. Despite differences in when the exercise programmes commence (early vs delayed), identical exercise programmes will be implemented (see below)

Each exercise session will last 60 mins, incorporating approximately 30 to 45 minutes of aerobic exercise. Participants will take part in walking, cycling (seated and recumbent) and cross-training aerobic exercise. The remaining exercise session will consist of flexibility and balance exercises. Blood pressure, heart rate and RPE will be measured prior to, during and following each bout of aerobic exercise. It is anticipated that participants will exercise between 40 and 85% of age-predicted maximal heart rate during each aerobic exercise tasks. The exercise intensity will typically increase by ~5 % each week, although the rate of progression will be dependent upon how the subject feels during each session. The exercise sessions will be adminsitered by exercise physiologists working at Massey University. To monitor participant adherence to the exercise programme, attendance records will be monitored.

Intervention code [1] 287634 0
Rehabilitation
Intervention code [2] 287635 0
Behaviour
Intervention code [3] 287636 0
Prevention
Comparator / control treatment
The control condition will complete identical assessment procedures as those individuals randomized to the exercise group. Those randomized to the control condition at the completion of the baseline assessment will receive normal care (i.e. no additional supportive strategies will be implemented) during the 12 week exercise intervention.
Control group
Active

Outcomes
Primary outcome [1] 290130 0
Risk stratification values
cholesterol will be measured using a finger prick blood sample and a cardiocheck
Glucose will be measured using a finger prick blood sample and a glucometer
BP will be measured using a a stethoscope and sphygmomanometer
Timepoint [1] 290130 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [1] 303987 0
Physical fitness (exercise ECG stress test on a cycle ergometer). Blood pressure, ECG, heart rate and pereption of exertion measured throughout.
Timepoint [1] 303987 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [2] 303988 0
Psycho-social questionnaires (Profile of Mood States, Addenbroke Cognitive examination, modified barthel index),
Timepoint [2] 303988 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [3] 303989 0
Blood pressure will be measured using pulse wave analysis (automatic sphygomomanometer) and a finapres (small BP cuff on index finger)
Timepoint [3] 303989 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [4] 303990 0
Cerebral autoregulation and CO2 reactivity tests will be measured using transcranial doppler
Timepoint [4] 303990 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [5] 303991 0
Maximal knee extension and plantarflexion will be assessed on an isokinetic dynamometer
Timepoint [5] 303991 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [6] 304004 0
MicroRNA analysis - from venous blood sample
Timepoint [6] 304004 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [7] 304045 0
Carotid blood flow will be measured using doppler ultrasound
Timepoint [7] 304045 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [8] 304047 0
Arterial stiffness of the carotid artery will be measured using doppler ultrasound
Timepoint [8] 304047 0
Basline and post intervention [12 weeks after baseline]
Secondary outcome [9] 304048 0
Cerebral blood flow will be measured using transcranial doppler
Timepoint [9] 304048 0
Basline and post intervention [12 weeks after baseline]

Eligibility
Key inclusion criteria
Inclusion criteria:
1) Those diagnosed with a stroke (ischaemic, atherosclerotic) or high risk TIA (with ABCD2 score >/=4), after review by a specialist stroke physician
2) Those living within Wellington City and the Greater Wellington region

Minimum age
No limit
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1) Oxygen dependence
2) uncontrolled angina
3) unstable cardiac conditions
4) uncontrolled diabetes mellitus
5) major medical conditions
6) claudication
7) febrile illness
8) significant cognitive impairment
9) immobile
10) age>85 years

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 and stroke in the Region. Referrals are received via telephone, fax or e-mail from General Practitioners, the Emergency Department and Paramedics. All referrals are reviewed by a specialist physician and appropriate diagnostic tests undertaken, as per the NZ TIA and stroke guidelines. Thosewho meet the study's inclusion and exclusion criteria will be invited to participate.

Following the baseline assessments participants will be randomized to either an early or delayed exercise programme, or to a normal care control group. the Randomization will 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 = Early Exercise; B = Delayed Exercise; C = Control) will be placed in a sequentially numbered envelope (from 1-45) based on the derived sequence generated by the website.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Due to the pilot nature to this study it was decided that 15 subjects in each condition (15 in early exercise condition; 15 in delayed exercise condition' 15 in control condition) would elicit enough data to provide statistical and power calculations for a fully randomized controlled trial.

A series of two way repeated measures analyiss of variance (aNOVA) will be used to assess the effect of the treatment condition on primary and secondary outcomes reported at baselineand post-intervention.

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] 5257 0
New Zealand
State/province [1] 5257 0

Funding & Sponsors
Funding source category [1] 287714 0
University
Name [1] 287714 0
Massey University
Address [1] 287714 0
63 Wallace Street, Mt Cook, Wellington, 6140











Country [1] 287714 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
63 Wallace Street, Mt Cook, Wellington, 6140
Country
New Zealand
Secondary sponsor category [1] 286443 0
University
Name [1] 286443 0
University of Otago
Address [1] 286443 0
21 Mein Street, Newtown, Wellington, 6242
Country [1] 286443 0
New Zealand
Secondary sponsor category [2] 286444 0
Hospital
Name [2] 286444 0
Wellington Regional Hospital
Address [2] 286444 0
Riddiford St, Wellington, 6021
Country [2] 286444 0
New Zealand
Other collaborator category [1] 277553 0
Individual
Name [1] 277553 0
Dr Shieak Tzeng
Address [1] 277553 0
University of Otago, 21 Mein St, Newtown, Wellington, 6242
Country [1] 277553 0
New Zealand
Other collaborator category [2] 277554 0
Individual
Name [2] 277554 0
Dr Danielle Lambrick
Address [2] 277554 0
Massey University, 63 Wallace Street, Mt Cook, Wellington, 6140
Country [2] 277554 0
New Zealand
Other collaborator category [3] 277555 0
Individual
Name [3] 277555 0
Dr Lee Stoner
Address [3] 277555 0
Massey University, 63 Wallace Street, Mt Cook, Wellington, 6140
Country [3] 277555 0
New Zealand
Other collaborator category [4] 277556 0
Individual
Name [4] 277556 0
Mr Brandon Woolley
Address [4] 277556 0
Massey University, 63 Wallace Street, Mt Cook, Wellington, 6140
Country [4] 277556 0
New Zealand
Other collaborator category [5] 277557 0
Individual
Name [5] 277557 0
Dr Jeremy Lanford
Address [5] 277557 0
Wellington Regional Hospital, Riddiford St, Wellington, 6021
Country [5] 277557 0
New Zealand
Other collaborator category [6] 277558 0
Individual
Name [6] 277558 0
Dr Manning Sabatier
Address [6] 277558 0
Division of Physical Therapy
Dept of Rehabilitation Medicine
Emory University School of Medicine
1441 Clifton Rd, NE, Rm 209
Atlanta, GA 30322
Country [6] 277558 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289670 0
Central Rgional Health and Disability Erthics Committee
Ethics committee address [1] 289670 0
Ethics Committees
Health and Disability Services Policy
Population Health Directorate
Ministry of Health
133 Molesworth St
PO Box 5013
Wellington, 6011
Ethics committee country [1] 289670 0
New Zealand
Date submitted for ethics approval [1] 289670 0
Approval date [1] 289670 0
10/07/2013
Ethics approval number [1] 289670 0
13/CEN/72

Summary
Brief summary
Stroke is a leading cause of chronic disability in many developed countries, causing both physical and cognitive impairments. Research strongly suggests that rehabilitation should be started ‘early’ with this population group. However, on closer inspection, it is evident that there is little clear consensus about what constitutes ‘early’ and thus what the optimal time to start a rehabilitation program is. As such, there is limited evidence available to help guide best practice. In the acute and sub-acute phase of stroke care, getting the balance right between diagnosis, the start of therapies, medical interventions and exercise rehabilitation can be challenging. Improving our understanding of the impact of the rehabilitation intervention on brain recovery and functional restoration should be a priority.

The purpose of this research study is therefore to investigate the effect of early vs delayed exercise engagement (following stroke diagnosis) on cardiovascular and cerebrovascular health, cognition, psycho-social markers and physical fitness parameters in newly diagnosed stroke and high risk transient ischaemic attack (TIA) patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41866 0
Dr James Faulkner
Address 41866 0
Massey University, 63 Wallace Street, Mt Cook, Wellington, 6140
Country 41866 0
New Zealand
Phone 41866 0
+64, 04, 801 5799 ext 62104
Fax 41866 0
Email 41866 0
J.Faulkner@massey.ac.nz
Contact person for public queries
Name 41867 0
Dr James Faulkner
Address 41867 0
Massey University, 63 Wallace Street, Mt Cook, Wellington, 6140
Country 41867 0
New Zealand
Phone 41867 0
+64, 04, 801 5799 ext 62104
Fax 41867 0
Email 41867 0
J.Faulkner@massey.ac.nz
Contact person for scientific queries
Name 41868 0
Dr James Faulkner
Address 41868 0
Massey University, 63 Wallace Street, Mt Cook, Wellington, 6140
Country 41868 0
New Zealand
Phone 41868 0
+64, 04, 801 5799 ext 62104
Fax 41868 0
Email 41868 0
J.Faulkner@massey.ac.nz

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