Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000196741
Ethics application status
Approved
Date submitted
15/02/2013
Date registered
19/02/2013
Date last updated
19/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Longitudinal Study into Physical Activity and Cardiovascular Risk in People with Stroke
Scientific title
A Longitudinal Study into Physical Activity and Cardiovascular Risk in People with Stroke
Secondary ID [1] 281972 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity and Cardiovascular Risk in People with Stroke
 288399 0
Condition category
Condition code
Stroke 288747 288747 0 0
Ischaemic
Stroke 288748 288748 0 0
Haemorrhagic
Cardiovascular 288767 288767 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study, no intervention applied.
Measures will be taken at discharge from physiotherapy post stroke, 6, 12 & 24 months post this time.
The measures that are being taken include:
- Physical activity: the participants will wear a Sense-wear activity monitor for 5-7 days at each assessment point. The Sensewear activity monitor will measure energy expenditure, number of steps, position and physical activity duration. Questions will also be asked regarding regular physical activity.
- Cardiovascular risk factors: seated blood pressure, waist circumference, BMI & brief questions about smoking, diet & alcohol intake. Blood cholesterol & blood glucose measures will be taken at baseline, 12 & 24 months only.
- Physical mobility measures: 10 metre walk test, timed up & go, 6 minute walk test & functional ambulation category.
- Fatigue Severity Scale
- Hospital Anxiety & Depression Scale
- Montreal Cognitive Assessment
- Self-Report Barthel Index
Intervention code [1] 286541 0
Not applicable
Comparator / control treatment
Observational study, no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288886 0
To investigate and track physical activity levels in the two years following discharge from physiotherapy after first ever stroke.

Each participant will wear a Sense-wear activity monitor for 5-7 days to measure physical activity at each of the 4 assessment points (see below). Participants will also be asked questions regarding their regular physical activity.
Timepoint [1] 288886 0
Post discharge from physiotherapy (baseline), 6 months, 12 months and 24 months post baseline assessment.
Primary outcome [2] 288887 0
To investigate cardiovascular risk factors in the two years following discharge from physiotherapy after first ever stroke.

Cardiovascular risk factors will be assessed via standardised questions regarding smoking, alcohol and diet, seated blood pressure measurements, waist circumference and BMI measurements. Blood tests will also be taken in the week post assessment for measures of blood cholesterol & blood glucose.
Timepoint [2] 288887 0
Post discharge from physiotherapy (baseline), 6 months, 12 months and 24 months post baseline assessment.
Please note blood tests will only be performed at baseline, 12 & 24 months (ie not at the 6 month timepoint).
Primary outcome [3] 288888 0
To discover which groups of stroke survivors are most vulnerable to reduced physical activity and physical mobility and may therefore be at an increased cardiovascular risk.

Physical activity will be monitored via the Sense-wear activity monitors as described above.
Physical mobility will be assessed via simple clinical tests - the 10 metre walk test, the timed up & go, the 6 minute walk test & the functional ambulation categories.
Timepoint [3] 288888 0
Post discharge from physiotherapy (baseline), 6 months, 12 months and 24 months post baseline assessment.
Secondary outcome [1] 301246 0
To investigate physical mobility status via simple outcome measures in the year following discharge from rehabilitation after first ever stroke.

Physical mobility will be assessed via simple clinical tests - the 10 metre walk test, the timed up & go, the 6 minute walk test & the functional ambulation categories.
Timepoint [1] 301246 0
Post discharge from physiotherapy (baseline), 6 months, 12 months and 24 months post baseline assessment.

Eligibility
Key inclusion criteria
First ever stroke
Admitted to the neuro-rehabilitation unit at Caulfield Hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Length of stay <5 days
Palliative diagnosis
Live greater than 2 hours from Caulfield Hospital

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2012
Actual
20/11/2012
Date of last participant enrolment
Anticipated
31/12/2015
Actual
15/01/2015
Date of last data collection
Anticipated
Actual
5/12/2017
Sample size
Target
77
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 599 0
Caulfield Hospital - Caulfield
Recruitment postcode(s) [1] 6353 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 286746 0
Charities/Societies/Foundations
Name [1] 286746 0
Heart Foundation Post Graduate Scholarship
Country [1] 286746 0
Australia
Funding source category [2] 286747 0
Hospital
Name [2] 286747 0
Caulfield Hospital Research Grant
Country [2] 286747 0
Australia
Funding source category [3] 286748 0
Government body
Name [3] 286748 0
Victorian Stroke Clinical Network
Postgraduate Scholarship in Stroke Care
Country [3] 286748 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
La Trobe University
Melbourne Victoria 3086
Australia
Country
Australia
Secondary sponsor category [1] 285528 0
Hospital
Name [1] 285528 0
Caulfield Hospital, Alfred Health
Address [1] 285528 0
260 Kooyong Rd.
Caulfield
VIC 3162
Country [1] 285528 0
Australia
Secondary sponsor category [2] 285529 0
None
Name [2] 285529 0
Address [2] 285529 0
Country [2] 285529 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288818 0
The Alfred Ethics Committee
Ethics committee address [1] 288818 0
Ground Floor, Linay Pavilion
The Alfred
PO Box 315
Prahran
VIC 3181
Ethics committee country [1] 288818 0
Australia
Date submitted for ethics approval [1] 288818 0
Approval date [1] 288818 0
30/08/2011
Ethics approval number [1] 288818 0
297/11
Ethics committee name [2] 288819 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 288819 0
Research Compliance Unit / Research Services
La Trobe University
Bundoora
VIC 3086
Ethics committee country [2] 288819 0
Australia
Date submitted for ethics approval [2] 288819 0
Approval date [2] 288819 0
07/11/2011
Ethics approval number [2] 288819 0
11-055

Summary
Brief summary
Stroke is a major cause of disability in Australia, it affects over 50,000 people annually. Stroke survivors are at increased risk of health problems, particularly a second stroke. Many of the risk factors for a second stroke, such as smoking, poor diet and lack of physical activity could be reduced with increased awareness, education and support.

We plan to conduct a longitudinal study to investigate physical activity levels and cardiovascular risk factors in the 2 years following discharge from therapy after first ever stroke. Participants will be reviewed at baseline and at 6, 12 and 24 months following this. They will answer questions around their medical history and health status, complete questionnaires, have physical measurements taken (for example, blood pressure and walking tests) and be given activity monitors to wear for 5 days. At the baseline, 12 and 24 month assessments they will also be asked to have a blood sample taken within the following week.

We hope to identify relationships between physical activity, cardiovascular risk, physical function and fatigue levels. This study has not previously been undertaken and will provide essential information for clinicians, allowing them to target their interventions to specific risk factors and reduce risk of further stroke. If a link between physical activity and cardiovascular risk is demonstrated, a strong rationale will be provided for therapies that improve physical activity participation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37926 0
Ms Natalie Fini
Address 37926 0
Physiotherapy Department, Melbourne School of Health Sciences
Level 7, 161 Barry St, Alan Gilbert Building
The University of Melbourne
Parkville, VIC 3010
Country 37926 0
Australia
Phone 37926 0
+61 3 9035 8699
Fax 37926 0
Email 37926 0
[email protected]
Contact person for public queries
Name 37927 0
Natalie Fini
Address 37927 0
Physiotherapy Department, Melbourne School of Health Sciences
Level 7, 161 Barry St, Alan Gilbert Building
The University of Melbourne
Parkville, VIC 3010
Country 37927 0
Australia
Phone 37927 0
+61 3 9035 8699
Fax 37927 0
Email 37927 0
[email protected]
Contact person for scientific queries
Name 37928 0
Natalie Fini
Address 37928 0
Physiotherapy Department, Melbourne School of Health Sciences
Level 7, 161 Barry St, Alan Gilbert Building
The University of Melbourne
Parkville, VIC 3010
Country 37928 0
Australia
Phone 37928 0
+61 3 9035 8699
Fax 37928 0
Email 37928 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
EmbaseWhat is the relationship between physical activity and cardiovascular risk factors in stroke survivors post completion of rehabilitation? Protocol for a longitudinal study.2017https://dx.doi.org/10.1136/bmjopen-2017-019193
EmbaseAdherence to physical activity and cardiovascular recommendations during the 2 years after stroke rehabilitation discharge.2021https://dx.doi.org/10.1016/j.rehab.2020.03.018
N.B. These documents automatically identified may not have been verified by the study sponsor.