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Fit 4 Me After Stroke (Moderate)

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001103752
Acronym
Fit 4 Me (Moderate)
Enrollment
14
Registered
2022-08-10
Start date
2022-09-28
Completion date
2027-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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)

Sponsors

The University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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)

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Sep 3, 2026