None listed
Conditions
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.
Interventions
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
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.
Sponsors
Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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).
Outcome results
None listed