ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001083785

Ethics application status

Approved

Date submitted

1/07/2022

Date registered

4/08/2022

Date last updated

13/04/2024

Date data sharing statement initially provided

4/08/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Fit 4 Me After Stroke (Mild)

Scientific title

Fit 4 Me After Stroke – A Phase I/IIA Clinical Trial investigating the dose of physical activity for people after stroke

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1279-9752

Trial acronym

Fit 4 Me (Mild)

Linked study record

This study is linked to ACTRN12622001103752 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

Condition category

Condition code

Stroke

Ischaemic

Stroke

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: Mild 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: Mild 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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

8 weeks after the initial program set-up session
(Step count is also measured at baseline)

Secondary outcome [1]

Feasibility
Adherence to planned physical activity program (number and duration of sessions) recorded in the participants’ activity diary.

Timepoint [1]

8 weeks & 6 months after the initial program set-up session

Secondary outcome [2]

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 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]

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]

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]