Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001316291p
Ethics application status
Not yet submitted
Date submitted
1/08/2018
Date registered
6/08/2018
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Self-Managed Exercise Program for People with Stroke - THE TASK PROJECT
Scientific title
Does a self-managed exercise program, delivered via technology (the TASK program) improve physical activity for people with stroke who have been discharged from rehabilitation?
Secondary ID [1] 295712 0
None
Universal Trial Number (UTN)
Trial acronym
TASK Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 309109 0
Condition category
Condition code
Stroke 307984 307984 0 0
Ischaemic
Stroke 307985 307985 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From Week 1 to 4, participants will undertake TASK physiotherapist-supervised practice, for 30 minutes a week at the rehabilitation center. The rehabilitation center physiotherapists will provide the intervention with training and support from the research assistant and study investigators.
TASK is an exercise program that has been created by the chief investigator (Dr Kate Scrivener) in collaboration with physiotherapy students at Macquarie University.
The TASK Program involves the practice of five everyday tasks; sitting, standing up, standing, stepping and stepping up. Each task is practiced for approximately 5-minutes. The program is set to music. Each task has a video that demonstrates each exercise, highlights the correct technique and notes common errors.
During the four weeks of supervised training, the physiotherapist supervising the program will implement a self-management approach, in which they teach the participant how to monitor their own technique, how to progress or regress each exercise and how to alter the dose. The dose will be altered by varying the amount of repetitions of exercises completed within the same duration e.g. the speed of exercise completion. The main aim of these sessions will be to equip the participant with the skills needed to continue the program safely with increasing independence in the home.
From Week 5 to 12, participants will undertake TASK self-directed practice, for 30 minutes, three times a week at home. They will receive a resource package including a copy of the program (via app or website), exercise mat and exercise step. The floor mat is designed to be a visual cue to remind people to exercise within the home. Moreover, the mat guides equipment placement and provides targets for stepping. A member of the research team will contact each participant weekly via the participant’s preferred contact method (skype/facetime, voice phone or email). This contact will take a self-management approach and be designed to provide coaching, motivation, troubleshoot any issues and suggest progressions as appropriate. To monitor adherence to the program the participant will keep an exercise diary, furthermore the research team will access usage data from the application itself.
Intervention code [1] 302035 0
Rehabilitation
Intervention code [2] 302036 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306957 0
Physical activity measured using the Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [1] 306957 0
12 weeks post-enrolment to the study
Secondary outcome [1] 350257 0
Walking speed measured using the five metre walk test and reported as metres/second. A stopwatch will be used to measure time taken to walk the pre-marked 5m track.
Timepoint [1] 350257 0
12 weeks post-enrolment to the study
Secondary outcome [2] 350258 0
Satisfaction with program measured using a purpose built survey. In the survey participants will be asked four questions: (i) Were you satisfied with the TASK program? (ii) Was the TASK program easy to use? (iii) Did you enjoy using the TASK program? (iv) Would you recommend this program to others in your situation? The four questions will be rated on a 0-5 Likert Scale.
Timepoint [2] 350258 0
12 weeks post-enrolment to the study
Secondary outcome [3] 350259 0
Usage of app measured in two ways:
1. Each participant will complete an exercise training logbook documenting their adherence to the program.
2. Data will be obtained from the app itself and reported as minutes the app was accessed per day
Timepoint [3] 350259 0
This outcome will be assessed weekly for the 12 weeks of the study.
Secondary outcome [4] 350260 0
Data on near misses and adverse events will be collected. Adverse events will consist of minor events including muscle soreness and major events including falls and injuries requiring medical care. The physiotherapist providing remote support will question each participant weekly regarding the occurrence of adverse events.
Timepoint [4] 350260 0
This outcome will be assessed weekly for the 12 weeks of the study.

Eligibility
Key inclusion criteria
*Adult
*Have been discharged from formal rehabilitation
*Can walk at > 0.6 m/s with or without an aid
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Cannot read or understand verbal and written English
*Do not have sufficient cognition to participate in a video-guided independent exercise program (as determined by their treating physiotherapist)
*Do not have access to the internet at home.

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the sample. Feasibility (adherence, acceptability, safety) at Week 4 and Week 12 will be analysed using descriptive statistics. Clinical outcomes (physical activity, walking and self-efficacy) will be analysed using paired t-tests to determine any difference over time. The difference between Week 0 and 4 will reflect the supervised, institution-based practice of TASK, whereas the difference between Week 0 and 12 will reflect whether the self-directed, home-based practice of TASK has maintained any benefit. The difference will be presented as mean (95% CI) so that the reader can judge the clinical significance of the results. If the mean difference in physical activity is large enough (increase in physical activity of >20%), this will warrant a Phase II clinical trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
29/01/2021
Actual
Date of last data collection
Anticipated
30/04/2021
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300301 0
University
Name [1] 300301 0
Macquarie University
Country [1] 300301 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109
Country
Australia
Secondary sponsor category [1] 299734 0
None
Name [1] 299734 0
Address [1] 299734 0
Country [1] 299734 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301113 0
Ethics committee address [1] 301113 0
Ethics committee country [1] 301113 0
Date submitted for ethics approval [1] 301113 0
10/08/2018
Approval date [1] 301113 0
Ethics approval number [1] 301113 0

Summary
Brief summary
This study aims to investigate whether an exercise program (TASK), with a self-management approach is feasible in terms of assisting people living in the community with stroke to exercise on an ongoing basis. Self-management in a complex condition like stroke is difficult. For self-management to be successful, an individual requires knowledge and skills, as well as the self-efficacy to be able to manage their exercise over the long term. We propose applying a more structured approach to self-management that includes training, resources and ongoing support – the TASK program.

The proposed study includes two stages. In the first stage, participants will undertake the TASK program as physiotherapist-supervised practice. This practice is institution-based, supervised by physiotherapists and designed to progressively build knowledge and skills, and empower the person to exercise independently at home. In the second stage, participants will undertake TASK as self-directed practice, in which participants complete TASK independently at home. Throughout this stage participants will be provided with equipment, resources and ongoing remote support to complete the exercises.

We anticipate the TASK program will remove barriers for people with stroke to self-manage their exercise upon discharge from formal rehabilitation and enhance their confidence to be more physically active in daily life. If the TASK program proves to be successful, physiotherapists will have an engaging, accessible and easy to deliver tool to a population where ongoing intervention is lacking – therefore enabling ongoing exercise.
Trial website
https://www.mq.edu.au/about/about-the-university/faculties-and-departments/faculty-of-medicine-and-health-sciences/departments-and-centres/department-of-health-professions/our-research/task-program
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85906 0
Dr Katharine Scrivener
Address 85906 0
Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109
Country 85906 0
Australia
Phone 85906 0
+61298506625
Fax 85906 0
Email 85906 0
[email protected]
Contact person for public queries
Name 85907 0
Dr Katharine Scrivener
Address 85907 0
Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109
Country 85907 0
Australia
Phone 85907 0
+61298506625
Fax 85907 0
Email 85907 0
[email protected]
Contact person for scientific queries
Name 85908 0
Dr Katharine Scrivener
Address 85908 0
Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109
Country 85908 0
Australia
Phone 85908 0
+61298506625
Fax 85908 0
Email 85908 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
EmbaseFeasibility of a Self-Managed, Video-Guided Exercise Program for Community-Dwelling People with Stroke.2021https://dx.doi.org/10.1155/2021/5598100
N.B. These documents automatically identified may not have been verified by the study sponsor.