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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]

None

Universal Trial Number (UTN)

Trial acronym

TASK Project

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

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]

Rehabilitation

Intervention code [2]

Treatment: Other

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Physical activity measured using the Incidental and Planned Exercise Questionnaire (IPEQ)

Timepoint [1]

12 weeks post-enrolment to the study

Secondary outcome [1]

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]

12 weeks post-enrolment to the study

Secondary outcome [2]

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]

12 weeks post-enrolment to the study

Secondary outcome [3]

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]

This outcome will be assessed weekly for the 12 weeks of the study.

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

10/08/2018

Approval date [1]

Ethics approval number [1]

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

Dr Katharine Scrivener

Address

Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109

Country

Australia

Phone

+61298506625

Fax

kate.scrivener@mq.edu.au

Contact person for public queries

Name

Katharine Scrivener

Address

Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109

Country

Australia

Phone

+61298506625

Fax

kate.scrivener@mq.edu.au

Contact person for scientific queries

Name

Katharine Scrivener

Address

Department of Health Professions
Ground Floor, 75 Talavera Rd
Macquarie Park, NSW 2109

Country

Australia

Phone

+61298506625

Fax

kate.scrivener@mq.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

Source	Title	Year of Publication	DOI
Embase	Feasibility of a Self-Managed, Video-Guided Exercise Program for Community-Dwelling People with Stroke.	2021	https://dx.doi.org/10.1155/2021/5598100

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically