Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000746336
Ethics application status
Approved
Date submitted
19/03/2017
Date registered
22/05/2017
Date last updated
22/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Walking away fatigue and disease after stroke.
Scientific title
Feasibility of using accelerometers to reduce fatigue, improve beneficial activity behaviours and reduce risk of chronic disease after stroke: a pilot study.
Secondary ID [1] 291255 0
Nil known.
Universal Trial Number (UTN)
U1111-1193-4164
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 302185 0
Fatigue 302186 0
Chronic disease risk 302187 0
Physical activity 302188 0
Condition category
Condition code
Stroke 301797 301797 0 0
Haemorrhagic
Stroke 301798 301798 0 0
Ischaemic
Physical Medicine / Rehabilitation 302203 302203 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive a 6-week activity program to be performed independently, and a wrist-worn accelerometer. They will attend a weekly 60 minute one-on-one review session where a physiotherapist will review accelerometer data and assist the participant to develop goals and strategies to increase daily step count (up to 10,000 steps/day) and progressively increase the number of 10-minute moderate intensity activity bouts (up to 30minutes/day). Participants will wear a FitbitCharge HR continuously for 24-hours each day during the 6-week intervention period, which will provide real-time feedback on steps and heart rate to assist them in meeting daily activity goals.

At each weekly session, the investigator will review accelerometer data and assist the participant to develop goals and strategies to progressively increase daily step count and the number of 10-minute moderate intensity activity bouts. Strategies to increase volume and intensity of activity will be discussed. At each weekly session, the participant will perform a supervised exercise session that addresses their goals and strategies. The mode, volume and intensity will be individualized.

All participants in the intervention group will receive usual care and therapy prescribed by the rehabilitation team.
Intervention code [1] 297258 0
Treatment: Devices
Intervention code [2] 297259 0
Behaviour
Intervention code [3] 297642 0
Prevention
Comparator / control treatment
Participants in the control group will receive a weekly 60 minute one-on-one session with a physiotherapist to match dose of supervised sessions. During this session, the control group will receive education on stroke and discuss experiences in rehabilitation and returning home. These sessions will occur in a private consulting room at the hospital, or if discharged early, within the patient's home. Themes will include: patient-centred therapy, communication, readiness for discharge, and life after stroke.

Participants in the control group will not be wearing a FitbitCharge HR device.

All participants in the control group will receive usual care and therapy prescribed by the rehabilitation team.
Control group
Active

Outcomes
Primary outcome [1] 301210 0
Self-reported fatigue, measured via the Fatigue Severity Scale.
Timepoint [1] 301210 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Primary outcome [2] 301211 0
Feasibility: Recruitment feasibility will determined by the number of participants screened, and number eligible for inclusion. Feasibility of the protocol will be measured by recording the time taken to complete the measures and adherence. Feasibility of the intervention protocol will be measured by recording participant satisfaction (visual analogue scale), number of adverse events, and time taken to complete the intervention.
Timepoint [2] 301211 0
Feasibility measures will be collected throughout the study period.
Secondary outcome [1] 332041 0
Daily step count per day, measured via the ActivPAL accelerometer over 4 days.
Timepoint [1] 332041 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [2] 332042 0
Fasting glucose collected via a finger stick test.
Timepoint [2] 332042 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [3] 332043 0
Clinical risk factors for chronic disease (resting blood pressure measured via a sphygmometer and body mass index).
Timepoint [3] 332043 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [4] 332045 0
Gait speed (via the timed 10-metre walk test).
Timepoint [4] 332045 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [5] 334151 0
Blood lipids (HDL-C, LDL-,C, Total cholesterol, triglycerides) collected via a finger stick test.
Timepoint [5] 334151 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [6] 335125 0
Time spent in moderate intensity activity per day, measured via the ActivPAL accelerometer over 4 days.
Timepoint [6] 335125 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [7] 335126 0
Gait endurance (via the 6-minute walk test).
Timepoint [7] 335126 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).
Secondary outcome [8] 335127 0
Functional recovery (via the Motor assessment scale).
Timepoint [8] 335127 0
Baseline, at the completion of the 6-week intervention (post-intervention), and at 1-month following the completion of the 6-week intervention (1-month follow-up).

Eligibility
Key inclusion criteria
(1) diagnosed with stroke within the past 2 to 28 days, (2) aged > 18 years (3) able to walk independently 10 metres and (4) medically stable.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) a diagnosis of any other neurological condition, (2) co-morbidities limiting walking prior to stroke or (3) unable to follow 3-stage commands.

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)
Allocation concealment will be maintained throughout the study via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used for the data relating to feasibility, and all outcome measures. Within group paired t-tests, with mean and 95% confidence intervals will be used to compare groups in relation to effectiveness. No imputation of missing data will occur, but the reasons for missing data will be recorded as part of the feasibility of the trial.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/05/2017
Actual
Date of last participant enrolment
Anticipated
30/05/2019
Actual
Date of last data collection
Anticipated
11/08/2019
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,QLD
Recruitment hospital [1] 7552 0
The Canberra Hospital - Garran
Recruitment hospital [2] 7553 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 15444 0
2605 - Garran
Recruitment postcode(s) [2] 15445 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 295711 0
University
Name [1] 295711 0
Faculty of Health Research Grant, University of Canberra
Country [1] 295711 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
University of Canberra
1 University Drive,
Bruce
ACT 2617
Country
Australia
Secondary sponsor category [1] 294558 0
None
Name [1] 294558 0
Address [1] 294558 0
Country [1] 294558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297014 0
ACT Health Ethics Committee
Ethics committee address [1] 297014 0
Canberra Hospital
Yamba drive
Garran
ACT 2605
Ethics committee country [1] 297014 0
Australia
Date submitted for ethics approval [1] 297014 0
11/08/2016
Approval date [1] 297014 0
13/12/2016
Ethics approval number [1] 297014 0
8.16.157

Summary
Brief summary
To date, there are no evidence-based and feasible physical activity interventions for reducing fatigue and risk of chronic disease within the hospital inpatient setting after stroke. This pilot study has been based on (1) published results that identifies a relationship between low levels of activity and increased fatigue in people with stroke (2) known benefits of physical activity on risk of chronic disease and (3) low levels of daily activity observed across all phases of stroke recovery. This pilot study explores an intervention which uses commerical accelerometer feedback within the hospital inpatient setting to assist stroke survivors in achieving activity guidelines for health benefits.

30 mild-moderately disabled stroke survivors will be randomised into an experimental or control group 2 to 28-days after their stroke. Participants in the experimental group will complete a 6-week activity program with a weekly review by a physiotherapist. At the review, activity goals will be set to gradually increase daily step count (based on the participant’s daily step count from the preceding week) and increase time in moderate intensity walking bouts >10minutes duration via a graded protocol (i.e. gradual increase in time spent in moderate intensity activity per day). Participants will wear a FitbitCharge HR daily, which will provide real-time feedback on steps and heart rate to assist participants in meeting daily activity goals. Participants in the control group will receive a weekly one-on-one 60-minute session with a physiotherapist to match dose of supervised sessions. This session will be a face-to-face session either within the rehabilitation gym, or when discharged home prior to the 6th week, within the participant’s home with a registered physiotherapist. Outcomes including fatigue severity, daily activity, risk of disease and functional recovery following stroke will be measured at baseline, post-intervention and 1-month follow-up. Feasibility of intervention and measurement protocols, participant adherence and satisfaction, adverse effects and ease of implementation will be determined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72722 0
Dr Niru Mahendran
Address 72722 0
12D47, Faculty of Health
University of Canberra
1 University Drive,
Bruce
ACT 2617
Country 72722 0
Australia
Phone 72722 0
+612 62068302
Fax 72722 0
Email 72722 0
niru.mahendran@canberra.edu.au
Contact person for public queries
Name 72723 0
Dr Niru Mahendran
Address 72723 0
12D47, Faculty of Health
University of Canberra
1 University Drive,
Bruce
ACT 2617
Country 72723 0
Australia
Phone 72723 0
+612 62068302
Fax 72723 0
Email 72723 0
niru.mahendran@canberra.edu.au
Contact person for scientific queries
Name 72724 0
Dr Niru Mahendran
Address 72724 0
12D47, Faculty of Health
University of Canberra
1 University Drive,
Bruce
ACT 2617
Country 72724 0
Australia
Phone 72724 0
+612 62068302
Fax 72724 0
Email 72724 0
niru.mahendran@canberra.edu.au

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Results publications and other study-related documents

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