None listed
Conditions
Brief summary
Stroke rehabilitation remains limited in effective solutions for upper-limb recovery. Two key approaches include providing high doses of intensive training and leveraging strategies that harness neuroplasticity. Aerobic exercise has gained increasing attention for its ability to enhance neuroplasticity and accelerate motor learning. Evidence suggests that moderate and high-intensity exercise can increase excitability within the primary motor cortex in the chronic phases of stroke. Such evidence warrants further investigations into whether such aerobic exercise paradigms may increase the brain's responsiveness to rehabilitation. Therefore, this study seeks to investigate the feasibility of whether high-intensity interval training or moderate-intensity training on a recumbent exercise bike, 30 minutes before therapy, 3 days a week, over a 5-week intensive rehabilitation program, may help prime the brain for rehabilitation and further improve clinical outcomes in chronic stroke.
Interventions
This study is a randomised, 3-arm parallel adaptive trial assessing the feasibility, safety, and tolerability of two aerobic exercise primers of high-intensity interval training (HIIT) and moderate intensity training (MIT) prior to high-dose bootcamp rehabilitation in individuals with stroke. All participants will engage in high-dose bootcamp rehabilitation; only the aerobic exercise priming paradigm will vary across individuals. Aerobic Exercise Priming (Arm 1 & 2): Participants randomised into Arms 1 and 2 will be required to complete an aerobic exercise priming session on a recumbent exercise bike, approximately 30 minutes before their scheduled bootcamp rehabilitation session. This will be delivered in groups of up to 2-3. Individual prescription of exercise intensity will be determined using rate of perceived exertion (RPE) and heart rate (HR) response obtained from exercise testing (performed at enrolment as screening criteria). Participants will be required to complete three aerobic exercise priming sessions per week over the 5-week program duration. Arm 1: HIIT priming • Six blocks of 40 seconds of high-intensity intervals (RPE 14–16 or 70–85% HRR) with six blocks of 20 seconds of active recovery (RPE 10-11 or 20-35% HRR). • 5-minute warm-up and cool-down period of passive cycling at a low intensity of 10-25W Arm 2: MIT priming • 20 minutes of moderate-intensity continuous aerobic exercise (40-59% HRR or RPE 12-13/20). All exercise sessions will be supervised by the main researcher. Adherence to aerobic exercise priming sessions will be recorded. High-dose Boot Camp Rehabilitation: Every participant in the trial will complete an upper-limb sensorimotor rehabilitation program designed to address identified impairments and improve upper-limb function. Programs will be individually tailored based on initial assessments and rehabilitation goals. All participants will be required to complete a 5-week program delivering 3h per day, 5 days per week (total of 75h) comprising: 1) An upper-limb group exercise class (ratio 4:1), 2) Rehabilitation technologies (for example, robotics, virtual reality, EEG EMG biofeedback, non-immersive gaming, functional electrical stimulation and interactive multisensory gaming technologies, 3) task-specific training (1:1), 4) A home exercise program based on the Graded Repetitive Arm Supplementary Program (GRASP) or pre-recorded videos such as Different Strokes UK YouTube (informed by impairment level and patient preference). The GRASP program includes written and video guides to perform a range of exercises at home that include: stretching, arm strengthening, hand strengthening, coordination, and hand skills. The Different Strokes UK YouTube channel involves step-by-step videos to perform exercises that focus on mobility and movement, strength, core and range of motion. The 18h per week will be achieved by 13h delivered in person (based on tasks above) and 5h of home exercises (1h per weekday, recorded in an activity log). Adherence to both in-person and at-home will be recorded. Each 5-week program will have a maximum of 5 patients. A Physiotherapist will deliver all rehabilitation sessions. The adaptive element of this feasibility trial includes an interim analysis to assess whether arms may need to be discontinued if they meet any of the pre-defined feasibility and safety termination threshold criteria below: Serious adverse event: more than 20% of participants experience SAE related to exercise intervention. Adherence to exercise priming intervention: less than 50% of participants complete prescribed exercise sessions. Adherence to rehabilitation protocol: less than 50% complete rehabilitation sessions. Dropout rate: more than 50% withdraw from the arm. Acceptability: more than 50% rate the intervention as disagree or strongly disagree to being acceptable (5-point Likert scale). An interim analysis will be performed after 33% and 66% of data collection is completed. If an intervention arm is dropped due to meeting pre-defined stop criteria, randomisation ratios will be adjusted accordingly.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants will be recruited if they meet the following inclusion criteria: i) ischemic or haemorrhagic stroke ii) more than 3 months post-stroke, iii) 18+ years old, iv) deemed safe to participate in moderate and high-intensity exercise using the Australian Adult Pre-Exercise Screening System (APSS) and pre-intervention exercise testing vi) no cognitive impairment (Mini-Mental State Examination (score equal to, or more than 24) and v) evidence of upper limb motor impairment (Fugl-Meyer Upper-Extremity [FM-UE] score equal to, or more than 60).
Exclusion criteria
Exclusion criteria for the study include i) language, or cognitive impairments that prevent full participation, and ii) cardiovascular, neurological or musculoskeletal contraindications that may prevent safe exercise participation.