ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001733460

Ethics application status

Approved

Date submitted

9/12/2016

Date registered

16/12/2016

Date last updated

26/11/2018

Date data sharing statement initially provided

26/11/2018

Date results information initially provided

26/11/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Walking to better health after stroke

Scientific title

Feasibility study to evaluate a goal-directed, physiotherapy-facilitated walking programme for people after stroke to enhance health and wellbeing

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1190-7056

Trial acronym

Linked study record

Health condition

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

Stroke

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study will comprise a blinded (assessors and biostatistician but not participants) randomised controlled trial (RCT), followed by participant focus groups/interviews, to investigate the feasibility of using such a walking intervention to enhance health and wellbeing for people with stroke for a larger, future RCT. Participants allocated to the intervention group will undergo a 12-week walking programme facilitated by weekly contact with a physiotherapist as follows:
Intervention group participants:
Week 1 (1-1.5 hours)
a) The week following assessment, participants in the intervention group will meet the physiotherapist responsible for their individual programme at the physiotherapy clinic or at their home. Two to three physiotherapists will be trained in the delivery of the intervention protocol and in using behavioural techniques to facilitate participants to set their own walking goals and to assist in developing self-motivation to be able to continue walking for health and wellbeing without further oversight or encouragement following the 12-week programme. Participants will be allocated one physiotherapist who will work with them on an individual basis throughout. Each walking programme will be carried out in a location of the participants choosing eg within the home, outside, at a gym.
b) Participants will be provided with a Fitbit One(TM) activity monitor and a smartphone device programmed with the Fitbit(TM) App (participants can elect to use their own smartphone/tablet or laptop if available and preferred) and instructed how to use these devices. The number of steps a participant takes each day is displayed on the device and can be synchronised and viewed in the Fitbit(TM) App using a Bluetooth(TM) compatible device if the wearer is in close proximity. Both the participant and the physiotherapist will be able to access information from the Fitbit(TM) App following synchronisation.
c) Participants will complete a 10-minute self-efficacy walk using the Fitbit One(TM) to monitor step count in order to demonstrate Fitbit One(TM) use and aid participant and physiotherapist in setting individualised, realistic daily step goals during the programme.
d) Participants will be asked to familiarise themselves with wearing the Fitbit One(TM) and using the App over the following week with no specific step goal.
Week 2 (1-1.5 hours)
a) Participants will meet for a second time with the physiotherapist face-to-face, discuss Fitbit One(TM) use and, using motivational interviewing techniques, a daily step count goal will be agreed using step count information from the previous week and the self-efficacy walk.
b) Participants will learn how to introduce moderate or moderate-to-vigorous intensity walking elements into the programme using the Rate of Perceived Exertion (RPE) Scale. Perceived exertion is how hard a person feels they are physically working. During activity, participants will learn how to self-monitor how they feel on the RPE scale between 6 (no exertion) to 20 (maximal exertion) and adjust the intensity of their walking by altering the speed or gradient for example. Perceived exertion ratings between 12 to 14 (somewhat hard) on the RPE Scale suggest PA is being performed at a moderate level of intensity, whilst ratings of 15 to 16 (hard) suggests moderate to vigorous PA.
c) The physiotherapist will assist the participant in planning their weekly walking activity and exploring potential facilitators and barriers to success and how to document this in an electronic dairy or in a provided paper dairy (depending on participant’s preference).
Weeks 3-12 (30-60 minutes)
a) Over the subsequent 10-weeks participants will receive a mix of weekly face-to-face visits (to a maximum of six) and phone/video-conferencing (e.g. Zoom/Skype) calls by the physiotherapist. Each week participants will discuss their daily step counts, walking intensity, any problems encountered in reaching their walking goal and make plans for the following week. In this way the daily step count will hopefully be gradually increased in a manner acceptable to each individual participant. The target number of steps each participant takes per day will differ depending on the individual but will not exceed a 10% increase per week.
Following intervention
a) Immediately following completion of the 12-week programme, participants will return to see the blinded assessor for reassessment.
b) Participants will also be invited to participate in a focus group discussion designed to explore their thoughts and experiences of using the Fitbit(TM)-driven walking as a tool to encourage PA, changes to their walking/PA levels, ability to sustain changes and perspectives of walking on health and wellbeing.

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Comparator / control treatment

Participants in the control group will continue to receive routine/usual care. For the purposes of this study routine/usual care is defined as continuing to participate in normal daily activities. If control group participants are already receiving community or outpatient rehabilitation, if they attend the local gym or normally take daily walks, this can continue. Twelve weeks following initial assessment, control group participants will return to see the blinded assessor for reassessment. Control group participants will be offered a shortened and modified version (8-weeks) of the walking programme following reassessment. Participation is completely voluntary.

Control group

Active

Outcomes

Primary outcome [1]

Change in percentage of time spent in sedentary, moderate and vigorous activity under free-living conditions as measure by an accelerometer

Timepoint [1]

Participants will wear an accelerometer for 7 days pre and post the 12-week intervention

Primary outcome [2]

Quality of Life using the Stroke Specific Quality of Life Scale (SS-QOL)

Timepoint [2]

Pre and post 12-week intervention

Primary outcome [3]

Health & wellness using: Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)

Timepoint [3]

Pre and post 12-week intervention

Secondary outcome [1]

Resting systolic and diastolic blood pressure measured using manual blood pressure monitor.

Timepoint [1]

Pre and post 12-week intervention

Secondary outcome [2]

Cardiovascular endurance using the Six-minute walk test (6MWT)

Timepoint [2]

Pre and post the 12-week intervention

Secondary outcome [3]

Participant experience of walking intervention using qualitative methods - Participants will be invited to participate in a focus group discussion designed to explore their thoughts and experiences of using the Fitbit-driven walking as a tool to encourage PA, changes to their walking/PA levels, ability to sustain changes and perspectives of walking on health and wellbeing.

Timepoint [3]

Focus group post 12-week intervention

Secondary outcome [4]

Recruitment - as in how many people with stroke register an interest in the study, proportion of respondents meeting eligibility requirements and number of dropouts at randomisation, during intervention/non-intervention period and at 12-week reassessment.

Timepoint [4]

12 weeks

Secondary outcome [5]

Proportion of participants with self-reported or measured cardiovascular risk factors such as, hypertension, diabetes, obesity or smoking.

Timepoint [5]

Baseline

Secondary outcome [6]

Walking programme adherence via participant diary

Timepoint [6]

Post 12-week intervention

Secondary outcome [7]

Walking programme - Physiotherapy total contact time, number of face-to-face visits and, number of video-conference/phone contacts

Timepoint [7]

Post 12-week intervention

Secondary outcome [8]

Self-efficacy using the Stroke self-efficacy questionnaire (SSEQ)

Timepoint [8]

Baseline & 12-weeks

Secondary outcome [9]

UK Office for National Statistics (ONS) subjective well-being questions – a set of 4 questions with a response scale of 0-10, intended to capture what people think about their wellbeing.

Timepoint [9]

Baseline & 12-weeks

Secondary outcome [10]

Quality Adjusted Life Years (QALYs) – using the EuroQol health survey instrument (EQ-5D-5L)

Timepoint [10]

Baseline & 12-weeks

Secondary outcome [11]

Physiotherapist experience of providing the programme using qualitative methods - each physiotherapist will be offered a semi-structured interview to explore their experiences and thoughts on the intervention

Timepoint [11]

Following completion of the study

Eligibility

Key inclusion criteria

People with stroke living in the community (including rest homes) who are medically stable to embark on a walking programme and competent to provide written informed consent, as determined by their GP (or medical professional), will be invited to participate in the study. Participants must be independently ambulant (with or without mobility aids). Individuals under active treatment by a health professional will also be eligible to take part, as will those currently receiving no clinical intervention.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

People with stroke requiring assistance/supervision to ambulate will be excluded from enrollment, as will those with cognitive impairment resulting in an inability to understand the intervention or use the Fitbit One(TM) activity monitor and an inability to communicate in English.

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)

The study biostatistician will allocate participants in batches to the two groups and will not otherwise be involved in participant recruitment or screening. Non-informative group codes will be provided by the biostatistician and these will also be used for statistical analyses ensuring the biostatistician is blinded as to groups until primary analyses are completed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

In order to evaluate the feasibility of the walking intervention and our ability to retain participants in the wait-list control group for people of different ages (aged <65 or aged 65+), sex (male or female), ethnicity (Maori, European, and Other) and time since stroke (<6 months or 6 months+) we will use minimisation to produce approximately balanced groups (intervention and control) with regards to these four (equally-weighted) factors along with a small random component to preserve allocation concealment.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

As a feasibility study, significance testing is not the main quantitative goal—instead the focus will be on obtaining data for standard deviations and correlations between repeated measures and confidence intervals will be used to indicate plausible ranges of effects to inform the next phase of the research programme. Adherence levels and any recorded difficulties or adverse events experienced by the participants or therapists will be tabulated.
Focus group discussions will be audio-recorded, transcribed and imported into NVivo 11 (QSR International) software for analysis. Thematic analysis using inductive methods will be used to identify core ideas important to participants’ experience, meaning and reality of pedometer-driven walking

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2017

Actual

16/03/2017

Date of last participant enrolment

Anticipated

30/11/2017

Actual

14/12/2017

Date of last data collection

Anticipated

1/03/2018

Actual

24/04/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago Research Grant

Address [1]

University of Otago
PO Box 56
Dunedin 9054
New Zealand

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Dr Lynne Clay

Address

Centre for Health, Activity and Rehabilitation Research
School of Phyiotherapy
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Dr Sandra Mandic

Address [1]

School of Physical Education, Sport and Exercise Science
University of Otago
PO Box 56
Dunedin 9054

Country [1]

New Zealand

Secondary sponsor category [2]

Individual

Name [2]

Dr Gareth Treharne

Address [2]

Dept of Psychology
University of Otago
PO Box 56
Dunedin 9054

Country [2]

New Zealand

Secondary sponsor category [3]

Individual

Name [3]

Andrew Gray

Address [3]

Dept of Social & Preventative Medicine
University of Otago
PO Box 56
Dunedin 9054

Country [3]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Prof Suzanne McDonough

Address [1]

School of Health Sciences
Institute of Nursing and Health Research
Ulster University
Shore Road
BT37 0QB

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

20/12/2016

Approval date [1]

15/02/2017

Ethics approval number [1]

Summary

Brief summary

The aim of this research project is to determine whether a 12-week walking programme, provided and monitored by a physiotherapist, is a practical and reasonable way of improving the health and wellbeing of people following stroke. Forty people with stroke, living in the community (including rest homes), who are medically stable to embark on a walking programme will be randomly allocated to either a 12-week walking group or a usual care group. Participants in the walking group will wear a Fitbit(TM) activity tracker to monitor how many steps they take per day and will meet with a physiotherapist to plan a daily step count goal based on their individual ability. Each week participants will discuss their daily step counts, how much effort they are putting into their walking, any problems encountered in reaching their walking goal and make plans for the following week. In this way the daily step count will be gradually increased in a manner acceptable to each individual person. Participants physical activity level prior to the walking programme will be compared to their physical activity level after the walking programme. Participants will also be asked to discuss their experiences of the walking programme. Those allocated to the usual care group will continue with their normal routine for 12-weeks, after which, they will be offered an 8-week version of the walking programme.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/372007-Participant Information Sheet 29.11.16.docx (Participant information/consent)

Contacts

Principal investigator

Name

Dr Lynne Clay

Address

Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 3 479 5235

Fax

[email protected]

Contact person for public queries

Name

Dr Marina Moss

Address

Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 3 479 4979

Fax

[email protected]

Contact person for scientific queries

Name

Dr Lynne Clay

Address

Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054

Country

New Zealand

Phone

+64 3 479 5235

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Undecided

No/undecided IPD sharing reason/comment

Individual data would be available on request but not in public domain

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Basic results	No			372007-(Uploaded-26-11-2018-07-43-29)-Basic results summary.docx
Plain language summary	No		Walking programme with use of commercial activity ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Activity monitors for increasing physical activity in adult stroke survivors.	2018	https://dx.doi.org/10.1002/14651858.CD012543.pub2

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

Trial Review

Documents added manually

Documents added automatically