Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000764730
Ethics application status
Approved
Date submitted
4/07/2013
Date registered
9/07/2013
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The strokeIMPACT translation trial: IMproving Physical ACtivity via Treadmill training - Translating the evidence
Scientific title
How feasible and effective is it for physiotherapists to deliver a high intensity treadmill training and self-management program to stroke patients undergoing rehabilitation?
Secondary ID [1] 282786 0
Nil
Universal Trial Number (UTN)
U1111-1145-2834
Trial acronym
IMPACT translation (Improving Physical Activity via Treadmill Training - translation)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
People with stroke 289552 0
Condition category
Condition code
Stroke 289878 289878 0 0
Ischaemic
Stroke 289879 289879 0 0
Haemorrhagic
Neurological 289880 289880 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 up to 8 weeks at 60% heart rate reserve. Maximum possible total dose of treadmill training is 12 hours. Participants will be individually monitored throughout the treadmill sessions by a physiotherapist.

(2) Chronic Disease Self Management (CDSM) - During the same period that participants are receiveing treadmill training, they will also receive a CDSM program. This will involve 5-10 minute sessions, 3 times a week for up to 8 weeks. The sessions will be delivered individually to the participants by the treating physiotherapist 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] 287463 0
Rehabilitation
Intervention code [2] 287464 0
Prevention
Intervention code [3] 287465 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289938 0
Feasibility - Feasibility will be determined by: the number of stroke patients suitable for the intervention; compliance with the treadmill protocol; adverse events (for example, falls or patient-reported fatigue); participant satisfaction (assessed using a Likert Scale questionnaire designed specifically for this study).
Timepoint [1] 289938 0
Monitored daily throughout the 8 week intervention
Primary outcome [2] 289939 0
Physical activity - Actual activity levels (steps per day) measured over a 4 day period using an accelerometer (ActivPal)
Timepoint [2] 289939 0
Week 8, week 26
Secondary outcome [1] 303611 0
Walking ability (speed and endurance) as measured by the 6-minute walk test and the 10m walk test
Timepoint [1] 303611 0
Weeks 0,8,26
Secondary outcome [2] 303612 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] 303612 0
Weeks 0, 8, 26
Secondary outcome [3] 303613 0
Lipid profile and inflammatory markers (TC, HDL, LDL, TRG, hs-CRP) will be taken via a fingerstick and analysed on a point of care device
Timepoint [3] 303613 0
Weeks 0, 8, 26
Secondary outcome [4] 303614 0
Self-efficacy of walking ability will be measured using the Ambulatory Self-Confidence Questionnaire
Timepoint [4] 303614 0
Weeks 8 and 26
Secondary outcome [5] 303615 0
Health realted quality of life will be measured using the EuroQual-5D + VAS questionnaire
Timepoint [5] 303615 0
Weeks 8 and 26
Secondary outcome [6] 303616 0
Participation will be measured using the Impact on Participation and Autonomy Questionnaire (IPAQ)
Timepoint [6] 303616 0
Weeks 8 and 26
Secondary outcome [7] 303617 0
Subjectively measured physical activity will be measured by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)
Timepoint [7] 303617 0
Weeks 8 and 26
Secondary outcome [8] 303618 0
Burden of care will be assessed using the Caregiver Burden Scale
Timepoint [8] 303618 0
Weeks 8 and 26
Secondary outcome [9] 303619 0
Translation of treadmill training into clinical practice will be determined using a clinical practice audit of treatment during physiotherapy sessions. Therapist perceptions of barriers and facilitators to implementation of treadmill training will be determined using focus groups and semi-structured interviews
Timepoint [9] 303619 0
Throughout the 8 week intervention (focus groups will be conducted prior to the commencement of the intervention and semi-structured interviews will be conducted with therapists after they have had participants complete a full 8 weeks of the intervention).

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
Co-morbidities that might limit walking (e.g., arthritis, Parkinson's disease, brain injury)
Unstable cardiac status
Unable to understand instructions
Unable to provide informed consent

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)
Non-randomised pre-post intervention study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A sample size of 60 will be recruited to this study. This sample will be primarily one of convenience and aim to recruit people with a range of ages, stroke severity and functional ability post stroke across both genders. This sample size would enable us to detect an effect size of 0.5; which reflects a difference in physical activity of 1200 steps per day with 80% power at a two-tailed significance level of 0.05. This number is also sufficiently powered to detect clinically minimally important differences in secondary outcome measures.

Within groups statistical analysis will be performed on all outcome measures at all time points. Results will be reported as point measures and measures of variability. Primary and secondary outcome measures will be analysed using paired samples t-tests or repeated measures ANOVA or nonparametric analyses as appropriate. Results will be accepted as statistically significant at p< 0.05. SPSS 19.0 will be used and statistical significance will be set at 0.05 level of significance.

Qualitative component: Interviews will be transcribed verbatim and will analysed using a symbolic interactionism framework to explore therapist perception of the evidence regarding retraining walking and fitness, high-intensity treadmill training and the barriers and facilitators to implementing this. Interviews will be conducted prior to commencement of and on completion of the treadmill intervention with therapists across both facilities.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2013
Actual
14/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1204 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 1527 0
Brighton Day Surgery - Brighton
Recruitment postcode(s) [1] 7068 0
4032 - Chermside Centre
Recruitment postcode(s) [2] 7365 0
4017 - Brighton

Funding & Sponsors
Funding source category [1] 287558 0
Government body
Name [1] 287558 0
Office of Health and Medical Research
Country [1] 287558 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
St Lucia
Brisbane, QLD
4072
Country
Australia
Secondary sponsor category [1] 286309 0
University
Name [1] 286309 0
Griffith University
Address [1] 286309 0
Gold Coast campus
Southport
Queensland 4222
Country [1] 286309 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289535 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 289535 0
Ethics committee country [1] 289535 0
Australia
Date submitted for ethics approval [1] 289535 0
Approval date [1] 289535 0
20/11/2012
Ethics approval number [1] 289535 0
2012001247

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41238 0
Prof Sandra Brauer
Address 41238 0
Therapies Building (84a)
University of Queensland
St Lucia Campus QLD
4072
Country 41238 0
Australia
Phone 41238 0
+617 3365 2317
Fax 41238 0
+617 3365 2775
Email 41238 0
s.brauer@uq.edu.au
Contact person for public queries
Name 41239 0
Sandra Brauer
Address 41239 0
Therapies Building (84a)
University of Queensland
St Lucia Campus QLD
4072
Country 41239 0
Australia
Phone 41239 0
+617 3365 2317
Fax 41239 0
+617 3365 2775
Email 41239 0
s.brauer@uq.edu.au
Contact person for scientific queries
Name 41240 0
Sandra Brauer
Address 41240 0
Therapies Building (84a)
University of Queensland
St Lucia Campus QLD
4072
Country 41240 0
Australia
Phone 41240 0
+617 3365 2317
Fax 41240 0
+617 3365 2775
Email 41240 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
EmbaseHigh-intensity treadmill training and self-management for stroke patients undergoing rehabilitation: a feasibility study.2021https://dx.doi.org/10.1186/s40814-021-00941-w
N.B. These documents automatically identified may not have been verified by the study sponsor.