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Trial registered on ANZCTR


Registration number
ACTRN12611000630910
Ethics application status
Approved
Date submitted
20/04/2011
Date registered
21/06/2011
Date last updated
21/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of an exercise and education programme on transient ischaemic attack (TIA) and non-disabling stroke: a randomised controlled pilot trial
Scientific title
The effect of a Health Enhancing Physical Activity Programme (HEPAP) on transient ischaemic attack (TIA) and non-disabling stroke: a randomised controlled pilot trial
Secondary ID [1] 252747 0
Nil
Universal Trial Number (UTN)
U1111-1117-2046
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transient Ischaemic Attack (mini stroke) and non-disabling stroke 258249 0
Condition category
Condition code
Stroke 258424 258424 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
HEPAP (Exercise & Education Programme):
Participants randomized to the HEPAP condition (exercise and education) 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 resistance exercise, core-stability, balance, control, postural exerices, flexibility etc. Each session will also be followed by a 30 min group focused education section. 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 education component will cover issues such as signs and symptoms of TIA, physical activity opportunities in the local area, diet modification, pacing, goal setting and smoking cessation.
Intervention code [1] 257262 0
Prevention
Intervention code [2] 257263 0
Lifestyle
Intervention code [3] 257264 0
Behaviour
Comparator / control treatment
The control condition will complete identical assessment procedures as the HEPAP intervention. However, 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 8 week exercise and education intervention.
Control group
Active

Outcomes
Primary outcome [1] 259273 0
Risk stratification values (cholesterol, glucose, BP)
Timepoint [1] 259273 0
All assessments (basline, post intervention [PI], 3 months PI, 12 months PI)
Secondary outcome [1] 265693 0
Educational awareness of signs and symtpoms of stroke. This will be assessed using the Modified Stroke Awareness Questionnaire, a 10 item questionnaire that requires participants to correctly answer questions associated with signs, symptoms and risk factors of stroke/TIA.
Timepoint [1] 265693 0
All assessments (basline, post intervention [PI], 3 months PI, 12 months PI)
Secondary outcome [2] 265694 0
Physical fitness (exercise ECG stress test; submaximal cycle test)
Timepoint [2] 265694 0
All assessments (basline, post intervention [PI], 3 months PI, 12 months PI)
Secondary outcome [3] 265695 0
International Physical; Activity Questionnaire (IPAQ) - Used to measure health-related physical activity in everyday lives
Timepoint [3] 265695 0
All assessments (basline, post intervention [PI], 3 months PI, 12 months PI)
Secondary outcome [4] 276760 0
Hospital Anxiety and Depression Scale (HADS) - Measures anxiety (7 items) and depression (7 items)
Timepoint [4] 276760 0
All assessments (baseline, post intervention [PI], 3 months PI, 12 months PI)
Secondary outcome [5] 276761 0
Profile of Mood States (POMS) - 37 item questionnaire that measures depression (8 items), vigor (6 items), confusion (5 items), tension (6 items), anger (7 items) and fatigue (5 items).
Timepoint [5] 276761 0
All assessments (baseline, post intervention [PI], 3 months PI, 12 months PI)
Secondary outcome [6] 276762 0
Short-Form 36 (SF36) - Measures health and well-being
Timepoint [6] 276762 0
All assessments (baseline, post intervention [PI], 3 months PI, 12 months PI)

Eligibility
Key inclusion criteria
Diagnosis of TIA/non-disabling stroke after review by a specialist stroke physician at Wellington Hospital.
Minimum age
No limit
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

Study design
Purpose of the study
Prevention
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 HEPAP (exercise and education) or control group. 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 = HEPAP; B = Control) will be placed in a sequentially numbered envelope (from 1-60) 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] 2933 0
New Zealand
State/province [1] 2933 0

Funding & Sponsors
Funding source category [1] 257706 0
University
Name [1] 257706 0
Massey University
Address [1] 257706 0
63 Wallace Street, Mt Cook, Wellington, 6140
Country [1] 257706 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] 256922 0
Hospital
Name [1] 256922 0
Wellington Hopsital
Address [1] 256922 0
Riddiford St, Wellington, 6021
Country [1] 256922 0
New Zealand
Other collaborator category [1] 251529 0
Individual
Name [1] 251529 0
Dr Gerry McGonigal
Address [1] 251529 0
Floor 6, Grace Neil Block, Wellington Regional Hospital, Riddiford Street, Wellington, 6021
Country [1] 251529 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259740 0
Central Regional Ethics Committee, NZ
Ethics committee address [1] 259740 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] 259740 0
New Zealand
Date submitted for ethics approval [1] 259740 0
24/09/2010
Approval date [1] 259740 0
01/12/2010
Ethics approval number [1] 259740 0
CEN/10/10/046

Summary
Brief summary
For patients diagnosed with a transient ischemic attack (TIA; ‘mini’ stroke), management strategies are predominantly aligned with lifestyle (i.e. smoking cessation advice, diet, alcohol consumption) and pharmacological interventions.
Coronary Heart Disease and Cerebrovascular Disease (CVD) share many predisposing, modifiable risk factors such as hypertension, abnormal blood lipids, cigarette smoking, physical inactivity, obesity and diabetes. Research has shown benefits of exercise programmes and lifestyle education in the cardiac disease population (Jolifee et al., 2010). There is however the need to establish and identify the feasibility and efficacy of exercise based interventions as an early treatment strategy for patients with CVD to see if it is an effective approach towards preventing recurrent vascular events (Lennon & Blake, 2009; Yang et al. 2010)
The purpose of the present pilot study is therefore to examine whether an exercise and education intervention with patients post TIA (and non-disabling stroke) reduces risk factors aligned with CVD, increases physical fitness and the awareness of educational and health issues associated with TIA. This study will examine both the short-term and long-term effects of an exercise and education intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31682 0
Address 31682 0
Country 31682 0
Phone 31682 0
Fax 31682 0
Email 31682 0
Contact person for public queries
Name 14929 0
Dr James Faulkner
Address 14929 0
Massey University,
63 Wallace Street,
Mt Cook, Wellington
6140
Country 14929 0
New Zealand
Phone 14929 0
+64 (04) 801 5799 ext 62104
Fax 14929 0
Email 14929 0
J.Faulkner@massey.ac.nz
Contact person for scientific queries
Name 5857 0
Dr James Faulkner
Address 5857 0
Massey University,
63 Wallace Street,
Mt Cook, Wellington
6140
Country 5857 0
New Zealand
Phone 5857 0
+64 (04) 801 5799 ext 62104
Fax 5857 0
Email 5857 0
J.Faulkner@massey.ac.nz

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