Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000519550
Ethics application status
Approved
Date submitted
5/05/2015
Date registered
25/05/2015
Date last updated
10/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of different Lifestyle Interventions on Vascular Risk factors and Arterial stiffness in Non-disabling Stroke and Transient Ischemic Attack (TIA) patients
Scientific title
Effect of different Lifestyle Interventions on Vascular Risk factors and Arterial stiffness in Non-disabling Stroke and Transient Ischemic Attack (TIA) patients
Secondary ID [1] 286640 0
Nil
Universal Trial Number (UTN)
U1111-1169-8526
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-disabling stroke 294965 0
Transient Ischaemic Attack 294966 0
Condition category
Condition code
Stroke 295227 295227 0 0
Ischaemic
Cardiovascular 295291 295291 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 295292 295292 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline assessment - finger prick samples to measure blood profile markers. 12-lead ECG exercise stress test, to sub-maximal exhaustion (8mins) and images of the carotid artery via a pulsecor.

Exercise Intervention - 12 weeks, 40mins x 2 p/wk

ARM 1
Aerobic - 40mins of aerobic exercise -Starting at 75% HRR with an increment of 10% every 4th week i.e. 75%, 85%. 95% HRR. Protocol = interval training – 1min exercise; 15secs rest. Completed on treadmill or stationery ergometer.
ARM 2
Resistance - 40mins of circuit-resistance exercise – Starting at 75% HRR with an increment of 10% every 4th week i.e. 75%, 85%. 95% HRR. Protocol = interval training – 1min exercise; 15secs rest of 8 exercises (upper and lower body) x 4 sets
ARM 3
12-weeks of Nutritional education and group sessions, 2 x 45-60mins p/wk, will be undertaken at Wellington Hospital or other identified location for cooking demonstrations by dieticians. The nutritional guidance will be based on a whole foods plant based diet. Patients will be educated on the benefits of such a diet in regards to vascular risk factor control and reversal of atherosclerosis. Continued sessions will also concentrate on how to achieve this type of diet through group sessions and cooking demonstrations

Strategies to improve adherence:

Exercising in a group setting
Clinical Exercise Physiologists present at each exercise session to help monitor and ensure safety of participants
Intervention code [1] 291782 0
Rehabilitation
Intervention code [2] 291836 0
Lifestyle
Comparator / control treatment
Control group - usual care that is delivered by Wellington Hospital/DHB. This compromises of standard home -based rehabilitation if the stroke is severe, or an information pack containing different public resources available to the patient.
Control group
Active

Outcomes
Primary outcome [1] 294983 0
Two composite primary outcomes:

Aterial stiffness/compliance of carotid artery -

Using ultrasonography and pulse wave analysis (thickness of interior walls, and carotid blood velocity) - improvement would be recorded as greater then baseline assessment.

Central blood pressure - Sysytolic blood pressure decrease of 5mmHg
Timepoint [1] 294983 0
Post intervention (12 weeks)
Primary outcome [2] 294984 0
Vascular risk factors as assessed by finger prick blood sample measures, significant if there is a decrease in blood profile markers: total cholesterol [TC], high-density lipoproteins [HDL], low density lipoproteins [LDL], triglycerides [TG], TC:HDL ratio, fasting blood glucose (FBG)
Timepoint [2] 294984 0
Post Intervention (12 weeks)
Secondary outcome [1] 314504 0
Physical fitness - measured by heart rate at perceived levels of exertion; resistance at certain levels of perceived exertion when competing an exercise ECG submaximal stress test
Timepoint [1] 314504 0
Post intervention (12 weeks)

Eligibility
Key inclusion criteria
Inclusion criteria – located within CCDHB; diagnosed with non-disabling stroke/TIA by stroke physician. ABCD2 > 4 for those diagnosed with TIA for an indication of severity.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes: oxygen dependence, uncontrolled angina, unstable cardiac conditions, uncontrolled diabetes mellitus, febrile illness, claudication, significant cognitive impairment and immobility.

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)
Participants will be randomized on completion of the aforementioned baseline assessments. Participants will be randomly assigned using simple randomisation procedures (computerized random numbers; http://www.randomizer.org/form.htm) to either:

i) a 12 week aerobic exercise programme
ii) a 12 week resistance exercise programme
iii) Usual care control (CON) group
iv) Nutrition group


Details of the allocated group will be given on a piece of paper contained within sequentially numbered, opaque sealed envelopes. The randomisation procedures will be prepared by an investigator with no clinical involvement in the trial. Although participants and the health and exercise practitioners will be aware of the allocated treatment condition, outcome assessors and data analysts will be kept blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized on completion of the aforementioned baseline assessments. Participants will be randomly assigned using simple randomisation procedures (computerized random numbers; http://www.randomizer.org/form.htm)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2015
Actual
10/08/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6861 0
New Zealand
State/province [1] 6861 0
Wellington

Funding & Sponsors
Funding source category [1] 291214 0
University
Name [1] 291214 0
Massey University
Country [1] 291214 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Wallace street
Mt Cook
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 289893 0
None
Name [1] 289893 0
Address [1] 289893 0
Country [1] 289893 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292777 0
Health and Disability Ethics Commitees
Ethics committee address [1] 292777 0
Ministry of Health
Ethics Department
Reception - Ground Floor
20 Aitken Street
Thorndon
WELLINGTON 6011
Ethics committee country [1] 292777 0
New Zealand
Date submitted for ethics approval [1] 292777 0
14/05/2015
Approval date [1] 292777 0
01/07/2015
Ethics approval number [1] 292777 0
E6F7012

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 exercise rehabilitation can help with these impairments. However, on closer inspection, it is evident that there is little clear consensus on what type of exercise (aerobic or resistance) results in attenuating vascular risk factors to the greatest degree. As such, there is limited evidence available to help guide best practice. In the acute and subacute 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 exercise and nutrition interventions on vascular and functional restoration should be
a priority.

The purpose of this research study is therefore to investigate the effect of aerobic exercise, resistance exercise, the combination and nutrition (following stroke diagnosis) on vascular risk factors and arterial stiffness in newly diagnosed non- disabling stroke and transient ischemic attack (TIA) patients.

It is hypothesized that participation in a 12 week aerobic exercise program will Lead to significantly greater changes then:

Resistance exercise alone
Combination of resistance and aerobic exercise
Usual care control group
Nutrition group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56978 0
Mr Vishal Nagar
Address 56978 0
Work Address:
Massey University
Wallace Street, Mount Cook,
Wellington 6021
Country 56978 0
New Zealand
Phone 56978 0
+ 64 210574591
Fax 56978 0
Email 56978 0
[email protected]
Contact person for public queries
Name 56979 0
Mr Vishal Nagar
Address 56979 0
Work Address:
Massey University
Wallace Street, Mount Cook,
Wellington 6021
Country 56979 0
New Zealand
Phone 56979 0
+ 64 210574591
Fax 56979 0
Email 56979 0
[email protected]
Contact person for scientific queries
Name 56980 0
Mr Vishal Nagar
Address 56980 0
Work Address:
Massey University
Wallace Street, Mount Cook,
Wellington 6021
Country 56980 0
New Zealand
Phone 56980 0
+ 64 210574591
Fax 56980 0
Email 56980 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseThe role of diet in secondary stroke prevention.2021https://dx.doi.org/10.1016/S1474-4422%2820%2930433-6
N.B. These documents automatically identified may not have been verified by the study sponsor.