Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001289505
Ethics application status
Approved
Date submitted
18/11/2015
Date registered
26/11/2015
Date last updated
2/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fatigue After Stroke Trial (FAST): A randomised controlled study
Scientific title
FAST: A randomised controlled study of physical activity to reduce fatigue in stroke survivors
Secondary ID [1] 287920 0
None
Universal Trial Number (UTN)
U1111-1176-6301
Trial acronym
FAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 296802 0
Fatigue 296803 0
Condition category
Condition code
Stroke 297029 297029 0 0
Ischaemic
Stroke 297030 297030 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 297031 297031 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 10-week intervention incorporates 5 sessions and is designed to be carried out in the community, be inexpensive, and lead to long-term behaviour change. The intervention is scheduled to begin at 6 weeks post-stroke. The fortnightly sessions will be one-on-one discussions between the participant and the primary investigator (a neuropsychologist). Each session will be approximately 30 minutes in length and will incorporate 4 key elements to encourage physical activity.

1. Individual exercise preferences, assessed using the Stroke Exercise Preference Inventory (SEPI), will be used to inform personalised physical activity plans.
2. Goals for increasing physical activity will be established and reviewed in a collaborative process.
3. Electronic activity monitoring will provide continuous feedback on physical activity levels via a mobile phone app.
4. Peer support is incorporated into the app, and participants will also have the opportunity to engage with each other in an online forum.

Electronic activity monitoring will be used to monitor physical activity levels across the 10-week intervention period. Usage of the online forum will be recorded to monitor peer support activity.
Intervention code [1] 293280 0
Behaviour
Intervention code [2] 293289 0
Lifestyle
Comparator / control treatment
The control group will have a similar amount of contact with researchers during the intervention period, with 5 sessions. These sessions will include some assessment (e.g., fatigue, adverse events) and discussion about general aspects of recovery. Controls will not receive any active intervention elements (ie., no activity plans, no goal setting, no feedback, no link to peers).
Control group
Active

Outcomes
Primary outcome [1] 296637 0
Fatigue (FAS)
Timepoint [1] 296637 0
Post-test assessment (16 weeks post-stroke)
Primary outcome [2] 296638 0
Quality of life (AQOL-6D)
Timepoint [2] 296638 0
Post-test assessment (16 weeks post-stroke)
Secondary outcome [1] 318960 0
Fatigue (FAS)
Timepoint [1] 318960 0
Follow-up assessment (26 weeks post-stroke)
Secondary outcome [2] 318961 0
Quality of life (AQoL-6D)
Timepoint [2] 318961 0
Follow-up assessment (26 weeks post-stroke)
Secondary outcome [3] 318997 0
Cardiorespiratory fitness (VO2 peak) - assessed using a recumbent stepper
Timepoint [3] 318997 0
Post-test assessment (16 weeks post-stroke)
Secondary outcome [4] 318998 0
Muscle strength (hand grip and thigh) - assessed using hand grip dynamometer and manual muscle tester, respectively
Timepoint [4] 318998 0
Post-test assessment (16 weeks post-stroke)
Secondary outcome [5] 319013 0
Depression (PHQ-9)
Timepoint [5] 319013 0
Post-test assessment (16 weeks post-stroke)
Secondary outcome [6] 319014 0
Sleep efficiency - assessed using SenseWear activity monitor over 7 nights
Timepoint [6] 319014 0
Post-test assessment (16 weeks post-stroke)
Secondary outcome [7] 319015 0
Daytime sleepiness (ESS)
Timepoint [7] 319015 0
Post-test assessment (16 weeks post-stroke)
Secondary outcome [8] 319016 0
Sustained attention (PVT)
Timepoint [8] 319016 0
Post-test assessment (16 weeks post-stroke)

Eligibility
Key inclusion criteria
People with confirmed stroke (first ever or recurrent, haemorrhage or infarct) in the last 6 weeks, aged 18+ and fatigued, as indicated by a total score of greater than or equal to 24 on the Fatigue Assessment Scale (FAS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke survivors who: are not likely to be home within 6 weeks (e.g., severe stroke); have other progressive neurological disease (e.g. Multiple Sclerosis) or serious medical condition (e.g., cancer); have a premorbid modified Rankin Scale score of 3-5 (indicating moderate to severe disability); have severe heart failure or acute coronary syndromes; are palliated; have either aphasia or limited English precluding participation in the intervention; have low consciousness (unresponsive to verbal 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)
Yes - inclusion in the trial precedes the 6-week assessment. Once this assessment is complete, participants are centrally randomized by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated, stratified randomisation procedure will be used to ensure that the two groups are not imbalanced on sex or depressive symptoms.
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
Safety/efficacy
Statistical methods / analysis
Required sample for a potential Phase III trial was calculated for two-tailed testing of our co-primary outcomes using alpha = 0.025, power = 0.80, moderate effect sizes and 10% attrition. Using these parameters, we require 140 per group (280 total). In this Phase II trial, we aim to recruit 20% of this sample (56 patients) to determine safety, feasibility and estimates of effect size.

Primary outcomes will be analysed using Wilcoxon-Mann Whitney generalised odds ratio and multivariate regression. They will be intention-to-treat and will be adjusted for sex and depression. Secondary outcomes will be analysed using multivariate regression.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
Actual
12/11/2015
Date of last participant enrolment
Anticipated
28/02/2017
Actual
17/11/2016
Date of last data collection
Anticipated
Actual
5/05/2017
Sample size
Target
56
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4684 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 12263 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 292411 0
Charities/Societies/Foundations
Name [1] 292411 0
National Stroke Foundation
Country [1] 292411 0
Australia
Primary sponsor type
University
Name
Florey Institute of Neuroscience and Mental Health
Address
245 Burgundy St.
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 291098 0
None
Name [1] 291098 0
Address [1] 291098 0
Country [1] 291098 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293877 0
AUSTIN HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 293877 0
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria
Australia 3084
Ethics committee country [1] 293877 0
Australia
Date submitted for ethics approval [1] 293877 0
05/08/2015
Approval date [1] 293877 0
22/09/2015
Ethics approval number [1] 293877 0
HREC/15/Austin/335

Summary
Brief summary
Fatigue is experienced by more than 50% of stroke survivors, and leads to reduced independence and quality of life. It persists even after other symptoms have resolved. In spite of its importance to stroke survivors, there are no proven means of minimizing this fatigue. We plan to conduct a novel randomised controlled trial (RCT) to establish whether a 10-week intervention that increases the frequency and duration of physical activity after stroke will reduce fatigue and improve quality of life. The intervention has 4 key elements: personalised physical activity plans, goal setting, daily feedback and peer support. Our aim is to increase habitual activity levels through long-term behaviour change; the intervention is not reliant on specialised equipment or services. Outcomes will be assessed before and after the intervention period. In addition to the primary outcomes of fatigue and quality of life, we will assess physical activity levels, sleep, fitness, muscle strength, depression and anxiety. Currently, there is uncertainty about whether to prescribe exercise or rest to stroke survivors with fatigue. Evidence that physical activity improves post-stroke fatigue has the potential to change practice, translating directly into clinical guidelines.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61606 0
Dr Toby Cumming
Address 61606 0
Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg
Victoria 3084
Country 61606 0
Australia
Phone 61606 0
+61390357152
Fax 61606 0
Email 61606 0
toby.cumming@florey.edu.au
Contact person for public queries
Name 61607 0
Dr Toby Cumming
Address 61607 0
Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg
Victoria 3084
Country 61607 0
Australia
Phone 61607 0
+61390357152
Fax 61607 0
Email 61607 0
toby.cumming@florey.edu.au
Contact person for scientific queries
Name 61608 0
Dr Toby Cumming
Address 61608 0
Florey Institute of Neuroscience and Mental Health
245 Burgundy St
Heidelberg
Victoria 3084
Country 61608 0
Australia
Phone 61608 0
+61390357152
Fax 61608 0
Email 61608 0
toby.cumming@florey.edu.au

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