Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001103752
Ethics application status
Approved
Date submitted
4/08/2022
Date registered
10/08/2022
Date last updated
13/04/2024
Date data sharing statement initially provided
10/08/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Fit 4 Me After Stroke (Moderate)
Scientific title
Fit 4 Me After Stroke – A Phase I/IIA Clinical Trial investigating the dose of physical activity for people after moderate severity stroke
Secondary ID [1] 307672 0
None
Universal Trial Number (UTN)
U1111-1279-9752
Trial acronym
Fit 4 Me (Moderate)
Linked study record
This study is linked to ACTRN12622001083785 as part of the same 'super umbrella' trial investigating different doses of a physical activity intervention for stroke survivors.

Health condition
Health condition(s) or problem(s) studied:
Stroke 327205 0
Condition category
Condition code
Stroke 324343 324343 0 0
Ischaemic
Stroke 324344 324344 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Please note that this intervention and resources have been co-designed with stroke survivors, carers and clinicians.

All interventions will be carried out by a physiotherapist or exercise physiologist with at least 3 years experience working with stroke survivors.

Resources for participants (stroke survivors): Decision aid / infographic about physical activity, written & audio-visual information about physical activity risks/benefits/safety, physical activity options infographic, physical activity plan and activity diary, Fitbit device.

Resources for therapists: shared decision-making flow chart and guide, goal-setting resource, physical activity options list, behaviour change technique options list

Arm 1: Moderate Severity Stroke Survivors, Light Intensity Physical Activity
The initial intervention will be a face to face consultation lasting 45-60 minutes. At this session the shared-decision making process will be commenced and will involve information exchange about physical activity, exploring participant’s prior experiences and values, along with barriers and enablers of physical activity. Physical activity goals will be collaboratively devised.
From these discussions which will include the participants' physical activity preferences the therapist will allocate the participant to the light or moderate to vigorous treatment arm.

Session 2: Shared Decision-Making & Planning
This session is also a face to face session lasting 45-60 minutes and will occur within 2 weeks of the initial session.
The main component of the intervention is the shared decision-making and planning session. In this session the physical activity program and plan is developed collaboratively with participants.

A plan for monitoring and review is also made and agreed upon – this will include the frequency and mode of review (e.g. face to face, videoconference, telephone call, email or text).

At this session, participants are also provided with the Fitbit Inspire 2 device and taught how to monitor their activity.

Program set-up & in-person assistance with physical activity program:
Program set-up occurs within 2 weeks of the Session 2 Shared Decision-Making and planning session.
As part of the plan the therapist may attend the first 2-5 sessions of the physical activity program over the first 2 weeks with the participant to facilitate the program and help to problem solve through any issues (e.g. how to perform a particular task, alter set up, or monitor activity intensity).
These sessions will occur at the location that the physical activity will take place in for example the participants’ home, local gym, park, community centre. Further in-person assistance may be offered at any stage over the first 8 weeks of the program if an issue arises.

All aspects of the physical activity program will be personalised according to participant preferences (ie type, location, delivery mode and group/individual). If it is a group exercise format it will not be with other participants in the trial, but rather in already established community group exercise program's of the participants' choosing. The duration of weekly physical activity will be determined by the trial design algorithm and results of previous cohorts of 5. The duration dose for the initial cohort of 5 will be 90 minutes per week over the duration of the trial and can be performed in any combination of frequency and duration over the week that suits the participant. (Subsequent cohorts will have their weekly duration increased by 20 minutes per week, decreased by 20 minutes per week or kept at 90 minutes per week). Participants will be taught to monitor the intensity of their activity with the Borg RPE scale and their heart rate using the Fitbit device. It will be formally assessed with an actigraph.

Program support provided during weeks 3-8 of the program:
Therapists will provide at least weekly and at most 3 times weekly monitoring and support over the first 8 weeks of the program. Sessions are anticipated to be between 10-30 minutes. This will be via the participant’s preferred mode of delivery (e.g. face to face, videoconference, telephone call, email or text) and will be a casual discussion/interaction to help with problem solving any issues arising, tracking progress and provide motivational support.
Behaviour Change Techniques will be applied as part of this stage of the intervention to support the participant during this time, examples include: goal setting, problem solving and action planning.

An actigraph device will be given to participants to wear on the ankle for 2 x 1-week timepoints at approximately weeks 2-3, and 5-6. The results of the activity monitoring will be used to provide feedback to the participant about their intensity of activity and they will be encouraged to adhere to the intensity target for their specific trial arm (Light or Moderate-Vigorous intensity physical activity).

Program support and monitoring over months 3-6 (weeks 9-26) of the program:
From months 3-6 of the program monitoring and support will become less frequent and be tapered over time (according to participant preference). During months 3 and 4 therapists will have contact at most once per week and at least fortnightly. During month 5 ideally only 1-2 contacts will be provided and in month 6 there will be 1 final contact.

After month 6 participants are encouraged to continue with their physical activity program (albeit without any support directly from the study).

Arm 2: Moderate Severity Stroke Survivors, Moderate-Vigorous Intensity Physical Activity
Same as Arm 1, except that the chosen physical activity will be of a higher intensity (e.g., brisk walking, cycling)
Intervention code [1] 324146 0
Lifestyle
Intervention code [2] 324147 0
Behaviour
Intervention code [3] 324148 0
Rehabilitation
Comparator / control treatment
There is no comparator or control group as it is an early phase trial.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 332148 0
The Primary Outcome is the DESIRABILITY OF A DOSE at 8 weeks quantified using UTILITY which is the efficacy/dose limiting trigger (DLT) trade-off where:

- Efficacy is greater than or equal to 20% improvement in average daily step count (measured over 7 days with a Fitbit Inspire 2 activity monitor)

- Absence of DLTs is defined as both adherence to physical activity intensity and duration dose (within 10%, assessed via an activity diaries and an actigraph device) and no serious intervention-related adverse event.

The safety or tolerance aspect DLT aspect of utility is discomfort/fatigue that limit physical activity at the prescribed dosage or impact ability to carry out regular daily tasks. Fatigue and discomfort following sessions that do not limit participation (i.e., are not dose-limiting) will not impact that dose escalation/de-escalation schedule.
Timepoint [1] 332148 0
8 weeks after the initial program set-up session
(Step count is also measured at baseline)
Secondary outcome [1] 412370 0
Feasibility
Adherence to planned physical activity program (number and duration of sessions) recorded in the participants’ activity diary.
Timepoint [1] 412370 0
8 weeks & 6 months after the initial program set-up session
Secondary outcome [2] 412371 0
Acceptability - measured via surveys and semi-structured interviews with thematic analysis

The survey is informed by the Theoretical Framework of Acceptability (TFA). The TFA considers seven constructs of acceptability: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness and self-efficacy.

The one-on-one semi-structured interviews will be conducted with a sample of participants in each group (approximately 8-10 per study). They will explore the participants experiences of the Fit 4 Me After Stroke program as well as any perceived barriers and facilitators. The interview questions have been structured using the TFA.
Timepoint [2] 412371 0
8 weeks and 6 months (survey) after the initial program set-up session
6 months (interviews) after the initial program set-up session
Secondary outcome [3] 412372 0
Systolic Blood Pressure
Average of 2 seated measurements, measured with a sphygmomanometer,
This outcome is also marked as a measure of further preliminary efficacy.
Timepoint [3] 412372 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [4] 412373 0
Average daily time spent sedentary.
Measured with the actigraph.
Timepoint [4] 412373 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [5] 412374 0
Subjective physical activity with the Stroke Physical Activity Questionnaire
Timepoint [5] 412374 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [6] 412375 0
Mood via the Hospital Anxiety & Depression Scale
Timepoint [6] 412375 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [7] 412376 0
Fatigue via the Fatigue Severity Scale
Timepoint [7] 412376 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [8] 412377 0
Self Efficacy via the Self Efficacy for Exercise Scale
Timepoint [8] 412377 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [9] 412378 0
Gait speed - stopwatch measurement of the participant walking over 10 metres.
Timepoint [9] 412378 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [10] 412379 0
Functional Ambulation Classification
Timepoint [10] 412379 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [11] 412380 0
Average daily time spent in light intensity activities.
Measured with an actigraph.
Timepoint [11] 412380 0
Baseline, 8 weeks & 6 months after the initial program set-up session
Secondary outcome [12] 412381 0
Average daily time spent in moderate to vigorous intensity activities.
Measured with an actigraph.
Timepoint [12] 412381 0
Baseline, 8 weeks & 6 months after the initial program set-up session

Eligibility
Key inclusion criteria
• Stroke survivors (first or recurrent) within 6 months of most recent stroke
• Adults (18 years years or older)
• Able to ambulate unassisted with or without an aid
- Gait speed slower than 0.8m/s unassisted (moderate cohort)

• Able to provide informed consent (with communication support if necessary; aphasia-friendly consent forms available)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to ambulate without physical assistance of another person
• Gait speed faster than 0.8 m/s
• Live greater than 2 hours from the University of Melbourne – as this will affect feasibility of assessments
• Concurrent palliative diagnosis, dementia or other diagnosis that may preclude participation in a physical activity program and study components.
• Severe communication or cognitive difficulties that preclude participation in a physical activity program and study components.
• Medical clearance not provided. Form to be completed by the participants’ general practitioner, or other medical specialist (e.g., neurologist, rehabilitation specialist, cardiologist).

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
Other
Other design features
This study is a multi-centre early-phase dose-escalation study.
A flexible Bayesian Optimal Interval phase I/II (BOIN12) design will be utilised. This novel design considers risks (safety/feasibility) and benefits (efficacy) when deciding to increase intervention dose and cohorts are subsequently allocated to a specific dose.

Two parallel studies will be conducted to find the physical activity dosage(s) that have the best chance of being both feasible and effective to take forward into a larger trial. (Two identical trials will be conducted in a mild (ACTRN12622001083785) and moderate cohort - current record).

The two arms of the study will test a different dose regimen with the aim of identifying the dose regimen that optimises the risk-benefit trade-off (discomfort prohibitive of continuing). Arm 1 will test Light Physical Activity (LPA) in mild stroke survivors, Arm 2 Moderate-Vigorous Physical Activity (MVPA) in mild stroke survivors, Decisions to escalate or de-escalate dose for the next cohort of 5 are made by simultaneously considering efficacy and safety/feasibility and adaptively allocating participants to the dose that optimises the efficacy/safety/feasibility trade-off.

Initially each arm of the study will test a physical activity duration dose of 90 minutes/week in a cohort of 5 participants, with up to 6 duration doses to explore for each study. Each arm of the study will have a maximum of 50 participants. Weekly physical activity duration dose will be escalated or de-escalated by 20 minutes as subsequent cohorts of 5 participants are enrolled, depending on outcomes and dose adherence at 8-weeks.

Once 20 participants (4 cohorts of 5) are enrolled in a dose without escalation or de-escalation, the arm of the study is stopped, and that dose is deemed appropriate to test in a larger trial. Each arm of the study will have a minimum sample size of 20 and a maximum of 50 as per trial design.

This means that the final sample size for the 2 arms of the study will be between 40 and 100 depending on the observed data.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Once 20 participants (4 cohorts of 5) are enrolled in a dose without escalation or de-escalation, the arm of the study is stopped, and that dose is deemed appropriate to test in a larger trial. Each arm of the study will have a minimum sample size of 20 and a maximum of 50 as per trial design.

This means that the final sample size for the 2 arms of the study will be between 40 and 100 depending on the observed data.

The desirability of all doses (quantified using UTILITY which is the efficacy/DLT trade-off) will be assessed through rank-based desirability scores as per BOIN I/II design. Doses with high desirability scores will be deemed as sufficiently promising for subsequent testing in later phase trials.

Further feasibility will be reported with adherence to the prescribed program via reporting proportion of sessions completed. Acceptability will be reported with survey responses reported as proportions of the sample.

For secondary and tertiary outcomes within-person changes in physical activity, blood pressure, mood, fatigue and self-efficacy will be estimated and the proportion of participants with changes will be reported. Due to the non-comparative nature of the studies, descriptive statistics will be used for exploratory analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/08/2022
Actual
28/09/2022
Date of last participant enrolment
Anticipated
1/01/2025
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
100
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22882 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [2] 22883 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 22884 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 22885 0
Caulfield Hospital - Caulfield
Recruitment hospital [5] 22886 0
Epworth Richmond - Richmond
Recruitment hospital [6] 22887 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 38190 0
3021 - St Albans
Recruitment postcode(s) [2] 38189 0
3052 - Parkville
Recruitment postcode(s) [3] 38192 0
3121 - Richmond
Recruitment postcode(s) [4] 38191 0
3162 - Caulfield

Funding & Sponsors
Funding source category [1] 311943 0
Charities/Societies/Foundations
Name [1] 311943 0
The Stroke Foundation
Country [1] 311943 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Grattan St
Parkville
VIC 3052
Country
Australia
Secondary sponsor category [1] 313426 0
None
Name [1] 313426 0
Address [1] 313426 0
Country [1] 313426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311372 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 311372 0
PO Box 2155
Parkville
VIC 3050
Ethics committee country [1] 311372 0
Australia
Date submitted for ethics approval [1] 311372 0
27/04/2022
Approval date [1] 311372 0
23/06/2022
Ethics approval number [1] 311372 0
HREC/86288/MH-2022 2022.133
Ethics committee name [2] 311374 0
The University of Melbourne
Ethics committee address [2] 311374 0
Office of Research Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [2] 311374 0
Australia
Date submitted for ethics approval [2] 311374 0
24/06/2022
Approval date [2] 311374 0
28/06/2022
Ethics approval number [2] 311374 0
2022-24721-29873-1

Summary
Brief summary
Being physically active is important for preventing stroke and other cardiovascular diseases. People who have already suffered a stroke are at a higher risk of future health problems. It can be challenging for stroke survivors to be active.

This research aims to test a pathway to personalised physical activity programs that our team has designed together with stroke survivors and clinicians.

The aim is to determine what physical activity dose (how much and how intense) is acceptable, feasible and safe for stroke survivors with moderate severity stroke, and is also effective at improving their cardiovascular health. This will ultimately reduce their risk of future stroke and cardiovascular disease. This trial will specifically investigate light and moderate to vigorous intensity physical activity in people with moderate severity stroke.

Participants will be prescribed a personalised physical activity program. The process will involve a shared decision-making and planning process to develop a personalised physical activity program.

The first 2 weeks will involve program set up. Support will be provided by a physiotherapist or exercise physiologist at least weekly over the first 3 months and may be face to face, via videoconference, phone or email–depending on the participants’ preference. Monitoring and support will continue, but decrease in frequency over the following 3 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120870 0
Dr Natalie Fini
Address 120870 0
Physiotherapy Department, Melbourne School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St Parkville
The University of Melbourne
Victoria 3010
Country 120870 0
Australia
Phone 120870 0
+61 401303749
Fax 120870 0
Email 120870 0
natalie.fini@unimelb.edu.au
Contact person for public queries
Name 120871 0
Dr Natalie Fini
Address 120871 0
Physiotherapy Department, Melbourne School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St Parkville
The University of Melbourne
Victoria 3010
Country 120871 0
Australia
Phone 120871 0
+61 401303749
Fax 120871 0
Email 120871 0
natalie.fini@unimelb.edu.au
Contact person for scientific queries
Name 120872 0
Dr Natalie Fini
Address 120872 0
Physiotherapy Department, Melbourne School of Health Sciences
Level 7, Alan Gilbert Building, 161 Barry St Parkville
The University of Melbourne
Victoria 3010
Country 120872 0
Australia
Phone 120872 0
+61 401303749
Fax 120872 0
Email 120872 0
natalie.fini@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a feasibility study and it would be difficult to protect anonymity if individual participant data is shared (potentially only 20 participants per trial). The consent form states that information will only be used for the purpose of this research project.


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
No additional documents have been identified.