Trial Review

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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 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] 290723 0
Nil known
Universal Trial Number (UTN)
U1111-1190-7056
Trial acronym
na
Linked study record
na

Health condition
Health condition(s) or problem(s) studied:
Stroke 301298 0
Condition category
Condition code
Stroke 301049 301049 0 0
Ischaemic
Stroke 301067 301067 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 301068 301068 0 0
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] 296622 0
Rehabilitation
Intervention code [2] 296623 0
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] 300473 0
Change in percentage of time spent in sedentary, moderate and vigorous activity under free-living conditions as measure by an accelerometer
Timepoint [1] 300473 0
Participants will wear an accelerometer for 7 days pre and post the 12-week intervention
Primary outcome [2] 300490 0
Quality of Life using the Stroke Specific Quality of Life Scale (SS-QOL)
Timepoint [2] 300490 0
Pre and post 12-week intervention
Primary outcome [3] 300491 0
Health & wellness using: Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Timepoint [3] 300491 0
Pre and post 12-week intervention
Secondary outcome [1] 330043 0
Resting systolic and diastolic blood pressure measured using manual blood pressure monitor.
Timepoint [1] 330043 0
Pre and post 12-week intervention
Secondary outcome [2] 330083 0
Cardiovascular endurance using the Six-minute walk test (6MWT)
Timepoint [2] 330083 0
Pre and post the 12-week intervention
Secondary outcome [3] 330088 0
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] 330088 0
Focus group post 12-week intervention
Secondary outcome [4] 330259 0
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] 330259 0
12 weeks
Secondary outcome [5] 330260 0
Proportion of participants with self-reported or measured cardiovascular risk factors such as, hypertension, diabetes, obesity or smoking.
Timepoint [5] 330260 0
Baseline
Secondary outcome [6] 330261 0
Walking programme adherence via participant diary
Timepoint [6] 330261 0
Post 12-week intervention
Secondary outcome [7] 330264 0
Walking programme - Physiotherapy total contact time, number of face-to-face visits and, number of video-conference/phone contacts
Timepoint [7] 330264 0
Post 12-week intervention
Secondary outcome [8] 330265 0
Self-efficacy using the Stroke self-efficacy questionnaire (SSEQ)
Timepoint [8] 330265 0
Baseline & 12-weeks
Secondary outcome [9] 330266 0
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] 330266 0
Baseline & 12-weeks
Secondary outcome [10] 330267 0
Quality Adjusted Life Years (QALYs) – using the EuroQol health survey instrument (EQ-5D-5L)
Timepoint [10] 330267 0
Baseline & 12-weeks
Secondary outcome [11] 330268 0
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] 330268 0
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?
No
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
40
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 8473 0
New Zealand
State/province [1] 8473 0
Otago

Funding & Sponsors
Funding source category [1] 295153 0
University
Name [1] 295153 0
University of Otago Research Grant
Country [1] 295153 0
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] 293973 0
Individual
Name [1] 293973 0
Dr Sandra Mandic
Address [1] 293973 0
School of Physical Education, Sport and Exercise Science
University of Otago
PO Box 56
Dunedin 9054
Country [1] 293973 0
New Zealand
Secondary sponsor category [2] 293974 0
Individual
Name [2] 293974 0
Dr Gareth Treharne
Address [2] 293974 0
Dept of Psychology
University of Otago
PO Box 56
Dunedin 9054
Country [2] 293974 0
New Zealand
Secondary sponsor category [3] 293975 0
Individual
Name [3] 293975 0
Andrew Gray
Address [3] 293975 0
Dept of Social & Preventative Medicine
University of Otago
PO Box 56
Dunedin 9054
Country [3] 293975 0
New Zealand
Other collaborator category [1] 279369 0
Individual
Name [1] 279369 0
Prof Suzanne McDonough
Address [1] 279369 0
School of Health Sciences
Institute of Nursing and Health Research
Ulster University
Shore Road
BT37 0QB
Country [1] 279369 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296504 0
Health and Disability Ethics Committee
Ethics committee address [1] 296504 0
Ethics committee country [1] 296504 0
New Zealand
Date submitted for ethics approval [1] 296504 0
20/12/2016
Approval date [1] 296504 0
15/02/2017
Ethics approval number [1] 296504 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1325 1325 0 0
/AnzctrAttachments/372007-Participant Information Sheet 29.11.16.docx (Participant information/consent)

Contacts
Principal investigator
Name 71086 0
Dr Lynne Clay
Address 71086 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 71086 0
New Zealand
Phone 71086 0
+64 3 479 5235
Fax 71086 0
Email 71086 0
[email protected]
Contact person for public queries
Name 71087 0
Marina Moss
Address 71087 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 71087 0
New Zealand
Phone 71087 0
+64 3 479 4979
Fax 71087 0
Email 71087 0
[email protected]
Contact person for scientific queries
Name 71088 0
Lynne Clay
Address 71088 0
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy
University of Otago
PO Box 56
Dunedin 9054
Country 71088 0
New Zealand
Phone 71088 0
+64 3 479 5235
Fax 71088 0
Email 71088 0
[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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseActivity monitors for increasing physical activity in adult stroke survivors.2018https://dx.doi.org/10.1002/14651858.CD012543.pub2
N.B. These documents automatically identified may not have been verified by the study sponsor.