Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000134628
Ethics application status
Approved
Date submitted
29/01/2014
Date registered
5/02/2014
Date last updated
5/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
How Fit is the Stroke Survivor? Can community-dwelling stroke survivors undertaking an individualised program to increase activity levels improve their cardiorespiratory fitness? A pilot study
Scientific title
Can community-dwelling stroke survivors undertaking an individualised program to increase activity levels improve their cardiorespiratory fitness compared to waitlisted control participants? A pilot study
Secondary ID [1] 283992 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
HowFITSS?
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 291033 0
Condition category
Condition code
Stroke 291370 291370 0 0
Ischaemic
Stroke 291415 291415 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 291416 291416 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a 12 week program to increase levels of physical activity and reduce sedentary behaviour. After the completion of baseline measures a physiotherapist and an exercise scientist consults with the participant for approximately 1 hour to discuss their program and to demonstrate/practice activities. Thereafter, participants exercise on their own. The program is individualised based on each participant's age, exercise preferences and access to resources and is carried out in their local community or at home. They are provided with an exercise manual that includes tips on overcoming barriers and tips for staying motivated, an exercise diary and suggested activities that can be done at home. Participants who are interested in using a pedometer are provided with one to provide feedback and to set targets. Participants are encouraged to exercise/ be active for at least 30 minutes most days of the week. They are also encouraged to break up long periods of sitting with some standing and walking. Activities at an intensity to improve cardiorespiratory fitness are strongly encouraged. During the 12 week program support is provided weekly via emails and/or phone calls. After the 12 weeks support is provided monthly up until the 12 month review. Participants are encouraged to contact the research team if they have any queries or issues.
Intervention code [1] 288682 0
Rehabilitation
Intervention code [2] 288683 0
Prevention
Intervention code [3] 288717 0
Behaviour
Comparator / control treatment
No treatment during 12 week waitlist period then receive the 12 week intervention
Control group
Active

Outcomes
Primary outcome [1] 291366 0
Peak oxygen consumption measured via a progressive exercise test with open circuit spirometry
Timepoint [1] 291366 0
12 weeks
Secondary outcome [1] 306602 0
Peak oxygen consumption measured via a progressive exercise test with open circuit spirometry
Timepoint [1] 306602 0
6 and 12 months
Secondary outcome [2] 306603 0
Walking ability using the 6 Minute Walk Test and 10m walk test (self selected and fast speeds)
Timepoint [2] 306603 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures
Secondary outcome [3] 306604 0
Number of shuttles achieved during the Shuttle Walk Test
Timepoint [3] 306604 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures
Secondary outcome [4] 306605 0
Knee strength measured on the Humac Norm
Timepoint [4] 306605 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures
Secondary outcome [5] 306606 0
Fatigue measured with the Fatigue Assessment Scale
Timepoint [5] 306606 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures
Secondary outcome [6] 306607 0
Health Related Quality of Life measured with the Stroke and Aphasia Quality of Life tool
Timepoint [6] 306607 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures
Secondary outcome [7] 306608 0
Mood measured with the Patient Health Questionnaire-9 (PHQ-9)
Timepoint [7] 306608 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures
Secondary outcome [8] 306609 0
Body composition measured with the InBody
Timepoint [8] 306609 0
At baseline, at the completion of a 12 week program, at 6 and 12 months after baseline measures

Eligibility
Key inclusion criteria
Community dwelling, adult stroke survivor within 1 year of last stroke, able to follow basic commands
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, deemed medically unfit to participate as determined by a medical practitioner (ASCM Contraindications to Exercise Testing- absolute and relative- are provided on the Medical Clearance form), unable to attend the centre for testing

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Intervention participants commence their 12 week program after baseline measures are completed. Control participants undergo baseline testing then are waitlisted for 12 weeks. They will then undergo testing again after these 12 weeks before crossing over to receive the intervention. All participants will be re tested after the 12 week program and at 6 and 12 months
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A convenience sample of 20 will be recruited to this study. We aim to see if the intervention is safe and effective for adult males and females over a range of ages. The pilot trial will examine the feasibility of the testing protocols as well as providing data on the amount of change observed in cardiorespiratory fitness after the intervention. This will inform the design of a larger randomised controlled trial.

Primary analysis: Intention to treat; Linear mixed model ANOVA will be used to compare treatment and control groups at 12 weeks.
Secondary analysis: Repeated measures ANOVA will be used to investigate changes from baseline in treatment group at 3 time points: 12 weeks, 6 months and 12 months.
Statistical significance will be set at p< 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/12/2012
Actual
12/12/2012
Date of last participant enrolment
Anticipated
28/02/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2003 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 2004 0
The Maitland Hospital - Maitland
Recruitment hospital [3] 2005 0
Belmont Hospital - Belmont
Recruitment postcode(s) [1] 7724 0
2280 - Belmont
Recruitment postcode(s) [2] 7722 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 7723 0
2320 - Maitland

Funding & Sponsors
Funding source category [1] 288619 0
Charities/Societies/Foundations
Name [1] 288619 0
National Stroke Foundation
Country [1] 288619 0
Australia
Funding source category [2] 288620 0
Hospital
Name [2] 288620 0
John Hunter Hospital Charitable Trust
Country [2] 288620 0
Australia
Funding source category [3] 288621 0
Other Collaborative groups
Name [3] 288621 0
Hunter Medical Research Institute
Country [3] 288621 0
Australia
Funding source category [4] 288622 0
Government body
Name [4] 288622 0
HNE Allied Health Research Committee Research Grant
Country [4] 288622 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive,
Callaghan,
NSW. 2308.
Country
Australia
Secondary sponsor category [1] 287328 0
Government body
Name [1] 287328 0
Hunter New England Local Health District
Address [1] 287328 0
Lookout Rd,
New Lambton Heights,
NSW. 2305.
Country [1] 287328 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290478 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 290478 0
Research Ethics and Governance Unit
District Headquarters- Administration Building
Lookout Road,
New Lambton,
NSW. 2305.
Ethics committee country [1] 290478 0
Australia
Date submitted for ethics approval [1] 290478 0
29/04/2011
Approval date [1] 290478 0
05/05/2011
Ethics approval number [1] 290478 0
11/04/20/4.04
Ethics committee name [2] 290480 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 290480 0
Research Services,
Research Integrity Unit,
HA148, Hunter Building,
The University of Newcastle,
University Drive,
Callaghan,
NSW. 2308.
Ethics committee country [2] 290480 0
Australia
Date submitted for ethics approval [2] 290480 0
15/06/2011
Approval date [2] 290480 0
04/07/2011
Ethics approval number [2] 290480 0
H-2011-0172

Summary
Brief summary
Stroke is common in Australia and the number of people experiencing stroke will increase with the ageing population. Currently, rehabilitation therapy after stroke focusses on restoring functions such as walking, swallowing and speech, with a primary goal of enabling people to return home. Improving physical fitness, particularly cardiorespiratory fitness, receives very little or no attention; however, improving fitness has the potential to enhance recovery of function, prevent future stroke or other cardiovascular events such as heart attacks, and improve the quality of life of stroke survivors.
Low levels of fitness make everyday activities difficult and fatiguing to perform and may also put the person at greater risk of another stroke. Studies of stroke survivors suggest they are only about half as fit as non-stroke people of a similar age. Unlike heart attack survivors who commonly access cardiac rehabilitation, fitness-training programs are not routinely available for stroke survivors. There have only been a small number of fitness training trials in stroke and most required participants to undergo expensive testing in a large hospital or research centre. The majority used a "one-program-fits-all" training approach and required participants to train at a single centre. Therefore the purpose of this project is to trial a physical activity program that is individualised to the participants' interests, abilities and access to equipment in their home or local community, is low-cost, and could be implemented anywhere in Australia. Participants will be provided with encouragement and support by phone and email, not only for the 12 weeks of the program but for the 12 month study duration. This pilot is a small, controlled trial where 50% participants will commence the program immediately while the other 50% will undergo baseline testing then be retested 12 weeks later before they start the program. We will compare fitness levels between those undergoing immediate and delayed fitness training, and measure changes before and after training as well as at 6 and 12 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45882 0
Dr Neil Spratt
Address 45882 0
Department of Neurology,
John Hunter Hospital,
Lookout Road,
New Lambton Heights,
NSW. 2305.
Country 45882 0
Australia
Phone 45882 0
+61 2 49213491
Fax 45882 0
Email 45882 0
Neil.Spratt@newcastle.edu.au
Contact person for public queries
Name 45883 0
Di Marsden
Address 45883 0
Hunter Stroke Service,
Level 2 The Lodge.
Rankin Park Campus
Lookout Road,
New Lambton Heights,
NSW. 2305.
Country 45883 0
Australia
Phone 45883 0
+61 2 49223380
Fax 45883 0
Email 45883 0
Di.Marsden@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 45884 0
Di Marsden
Address 45884 0
Hunter Stroke Service,
Level 2 The Lodge.
Rankin Park Campus
Lookout Road,
New Lambton Heights,
NSW. 2305.
Country 45884 0
Australia
Phone 45884 0
+61 2 49223380
Fax 45884 0
Email 45884 0
Di.Marsden@hnehealth.nsw.gov.au

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
EmbaseA Home- and Community-Based Physical Activity Program Can Improve the Cardiorespiratory Fitness and Walking Capacity of Stroke Survivors.2016https://dx.doi.org/10.1016/j.jstrokecerebrovasdis.2016.06.007
EmbaseCardiorespiratory fitness and walking endurance improvements after 12 months of an individualised home and community-based exercise programme for people after stroke.2017https://dx.doi.org/10.1080/02699052.2017.1355983
N.B. These documents automatically identified may not have been verified by the study sponsor.