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Trial registered on ANZCTR


Registration number
ACTRN12613000744752
Ethics application status
Approved
Date submitted
27/06/2013
Date registered
4/07/2013
Date last updated
7/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The stroke-IMPACT trial (Improving Physical Activity via Treadmill Training): A single blinded Randomised Controlled Trial.
Scientific title
In stroke patients undergoing rehabilitation, does high intensity treadmill training embedded in a self-management approach result in increased levels of physical activity at 8 and 26 weeks compared to usual physiotherapy care.
Secondary ID [1] 282750 0
None
Universal Trial Number (UTN)
U1111-1145-1004
Trial acronym
IMPACT RCT (Improving Physical Activity via Treadmill Training)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with stroke 289483 0
Condition category
Condition code
Stroke 289807 289807 0 0
Ischaemic
Stroke 289808 289808 0 0
Haemorrhagic
Neurological 289809 289809 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(1) Treadmill walking - 30 minute sessions, 3 times a week for 8 weeks at 60% of heart rate reserve. Total dose of treadmill walking is 12 hours. Participants will be individually monitored throughout the treadmill sessions by a physiotherapist.

(2) Chronic Disease Self Management (CDSM) - During the same 8 week period that participants are receiving treadmill training, they will also receive a CDSM program. This will involve 5-10 minute sessions, 3 times a week for 8 weeks. The sessions will be delivered individually to the participants by the physiotherapists prior to or during the treadmill sessions. Participants will be taught behaviour change techniques such as goal setting and action planning to encourage initiation and maintenance of physical activity.

(3) Usual care - Participants will also receive usual physiotherapy and rehabilitation during this time although treadmill training will replace over-ground gait retraining.
Intervention code [1] 287412 0
Rehabilitation
Intervention code [2] 287413 0
Prevention
Intervention code [3] 287415 0
Behaviour
Comparator / control treatment
Usual care - the comparison group will receive a usual physiotherapy rehabilitation program based on motor relearning principles. It is recommended that stroke patients receive up to 2 sessions of physiotherapy per day on 5 days of the week, prescribed by their treating physiotherapist. Usual hospital based care will be delivered by treating physiotherapists for the duration of the participant's hospital stay.
Control group
Active

Outcomes
Primary outcome [1] 289884 0
Physical activity - Actual activity levels (steps per day) measured over a 4-day period using an accelerometer (ActivPal)
Timepoint [1] 289884 0
Week 0, week 8, week 26
Secondary outcome [1] 303469 0
Walking ability (speed and endurance) as measured by the 6-minute walk test and the 10m walk test
Timepoint [1] 303469 0
Week 0, week 8, week 26
Secondary outcome [2] 303470 0
Cardiorespiratory fitness (VO2 Peak, Heart Rate, Blood Pressure and Rate Pressure Product) measured during the 6-minute walk test by a fully portable compact metabolic system using breath by breath analysis
Timepoint [2] 303470 0
Week 0, week 8, week 26
Secondary outcome [3] 303471 0
Cardiovascular risk will be measured from lipid profile and inflammatory markers. Lipid profile (TC, HDL, LDL, TRG, TC/HDL) will be taken via a fingerstick and analysed on a point of care device. Inflammatory markers (hs-CRP) will be measured by a pathology blood test
Timepoint [3] 303471 0
Week 0, week 8, week 26
Secondary outcome [4] 303472 0
Self-efficacy of walking ability will be measured using the Ambulatory Self Confidence Questionnaire
Timepoint [4] 303472 0
Week 8, week 26
Secondary outcome [5] 303473 0
Health related quality of life will be measured using the EuroQual-5D + VAS questionnaire
Timepoint [5] 303473 0
Week 8, week 26
Secondary outcome [6] 303474 0
Participation will be measured using the Impact on Participation and Autonomy Questionnaire (IPAQ)
Timepoint [6] 303474 0
Week 8, week 26
Secondary outcome [7] 303475 0
Subjectively measured physical activity will be measured using the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD) questionnaire
Timepoint [7] 303475 0
Week 8, week 26
Secondary outcome [8] 335735 0
Depression will be measured using the Hospital and Anxiety Depression Scale
Timepoint [8] 335735 0
Week 8, week 26

Eligibility
Key inclusion criteria
Within 2 months of stroke
Aged over 18 years
Able to walk independently for 10m with or without an aid
Able to understand 3-stage commands
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to walk independently prior to current stroke
Have co-morbidities that might limit walking (e.g., arthritis, brain injury, Parkinson's Disease)
Unstable cardiac status
Unable to understand/follow instructions
Unable to return for assessment or training
Unable to give informed consent

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)
Principal investigator will peruse admission list to identify potential participants. Regular contact will be made with treating physiotherapists. Once potential participant is identified, medical clearance will be sought from treating consultant. All potential participants will undergo assessment to ensure suitability. Once approval gained and participant consented, assessment by a blinded assessor will be arranged. Following assessment, subjects will be randomised. Allocation will be concealed through the use of consecutively numbered opaque sealed envelopes and will be maintained at a central location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Offsite investigator using computer generated random number program will randomise subjects into experimental and controlled groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 128 will be recruited to this study. To guide our effect size estimate of physical activity, we estimated that stroke patients would walk 4000 +/-2000 steps/day at baseline, that usual care would increase this by 1200 steps/day, and our intervention would further increase this by 50% (1200 steps/day, or a min of 3hrs/wk walking), putting them above a sedentary level for older adults. Thus we undertook a power analysis to detect an effect size of 0.5; which reflects a between independent group difference in physical activity of 1200 steps per day with 80% power at a two-tailed significance level of 0.05. This calculation resulted in requiring 55 participants per group, 110 participants in total. On the assumption from previous trials we have completed with this population that approximately 15% of participants may be lost to follow up during the course of the study, we have set a target of 128 participants in total.

Analysis will be intention to treat and between groups statistical analysis will be performed on all outcome measures. Results will be reported as point measures and measures of variability. Baseline demographic characteristics and outcome measures will be compared between participants according to group allocation and between those who completed the study and those who were lost to follow up. Primary and secondary outcome measures will be analysed using generalised estimating equations for continuous data. This approach is similar to repeated measures ANOVA but is tolerant of missing data and does not require casewise deletion due to missing values. Variables different between groups at baseline will be included as covariates. Kruskal-Wallis tests will be performed for non-parametric data. Results will be accepted as statistically significant at P<=0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2013
Actual
31/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
128
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1169 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 1170 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 1171 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains
Recruitment hospital [4] 1172 0
Gold Coast Hospital - Southport
Recruitment hospital [5] 8308 0
Prince of Wales Hospital - Randwick
Recruitment hospital [6] 8309 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 16371 0
2031 - Randwick
Recruitment postcode(s) [2] 7016 0
4006 - Herston
Recruitment postcode(s) [3] 7017 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 7018 0
4108 - Coopers Plains
Recruitment postcode(s) [5] 16372 0
4131 - Meadowbrook
Recruitment postcode(s) [6] 7019 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 287517 0
Government body
Name [1] 287517 0
National Health and Medical Research Council
Country [1] 287517 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Brisbane St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 286263 0
None
Name [1] 286263 0
Address [1] 286263 0
Country [1] 286263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289495 0
The University of Queensland
Ethics committee address [1] 289495 0
Brisbane St Lucia, QLD 4072
Ethics committee country [1] 289495 0
Australia
Date submitted for ethics approval [1] 289495 0
Approval date [1] 289495 0
24/05/2013
Ethics approval number [1] 289495 0
2013000639
Ethics committee name [2] 289904 0
Metro South Health Service District Human Research Ethics Committee (HHS HREC)
Ethics committee address [2] 289904 0
Centres for Health Research
Level 2 Building 35, Princess Alexandra Hospital
Ipswich Road, Woolloongabba Qld 4102
Ethics committee country [2] 289904 0
Australia
Date submitted for ethics approval [2] 289904 0
Approval date [2] 289904 0
15/05/2013
Ethics approval number [2] 289904 0
EC00167

Summary
Brief summary
Stroke is a leading cause of disability amongst Australians. After stroke, activity levels are low, with few people able to exercise at an intensity which will reduce the risk of future cardiovascular events. This project examines the effectiveness of implementing a combined high intensity treadmill training program embedded in a self-management approach to improve activity levels, mobility, cardiovascular risk profile in stroke survivors, increasing their independence and reducing the burden of care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41086 0
Prof Sandra Brauer
Address 41086 0
Therapies Building (84A)
The University of Queensland
St Lucia
QLD 4072 Australia
Country 41086 0
Australia
Phone 41086 0
+61 7 3365 2317
Fax 41086 0
+61 7 3365 2775
Email 41086 0
s.brauer@uq.edu.au
Contact person for public queries
Name 41087 0
Prof Sandra Brauer
Address 41087 0
Therapies Building (84A)
The University of Queensland
St Lucia
QLD 4072 Australia
Country 41087 0
Australia
Phone 41087 0
+61 7 3365 2317
Fax 41087 0
+61 7 3365 2775
Email 41087 0
s.brauer@uq.edu.au
Contact person for scientific queries
Name 41088 0
Prof Sandra Brauer
Address 41088 0
Therapies Building (84A)
The University of Queensland
St Lucia
QLD 4072 Australia
Country 41088 0
Australia
Phone 41088 0
+61 7 3365 2317
Fax 41088 0
+61 7 3365 2775
Email 41088 0
s.brauer@uq.edu.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
EmbaseImproving physical activity after stroke via treadmill training and self management (IMPACT): A protocol for a randomised controlled trial.2018https://dx.doi.org/10.1186/s12883-018-1015-6
N.B. These documents automatically identified may not have been verified by the study sponsor.