Stroke Circulatory System
Conditions
Interventions
Type of exercise
All exercise will be performed on three seated PACE machines manufactured by Innerva: Cross Cycle, Chest and Legs, and Tricep Dip Leg Press. Participants will be supervised whilst tra
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Community dwelling adult aged 18 years or older (The study will not be delivered to people receiving in-patient rehabilitation) 2. Confirmed diagnosis of stroke; haemorrhagic or ischaemic (People with recurrent strokes will be eligible for recruitment) 3. Modified Rankin Scale score of 3 or 4 (We aim to target people living with some mobility impairment and/or dependence in activities of daily living. This will ensure that people typically excluded from previous exercise trials for stroke will have the opportunity to participate. The criteria developed by [London and Karmal 2025] will be implemented during the screening process to determine Modified Rankin Scale score) 4. Able to comprehend purpose of the study and provide informed consent (During the screening telephone call or home visit the Chief Investigator who is a Chartered Physiotherapist with expertise in stroke rehabilitation, will consider whether the potential participant has comprehended the purpose of the study and the commitment associated with participation. We do not plan to conduct quantified tests of mental capacity (e.g. Mini Mental Test) as this would not represent real world practice)
Exclusion criteria
Exclusion criteria: 1. Contraindication to exercise according to American College of Sport’s Medicine (The screening telephone call or home visit will include questions about past medical history,current investigations,active treatments and prescribed medication. Wherever there is a concern about safety to engage in exercise due to a co-existing medical condition(s) recruitment to the study will be deferred and a medical review from either the GP or Co-Investigator,Dr Ali Ali (stroke consultant) will be requested) 2. The baseline assessment will include a submaximal exercise test with a target intensity of 85% age-predicted maximum heart rate (adjusted for beta-blockers). Heart rate,observed exertion and reported exertion will be monitored throughout the test. Blood pressure and oxygen saturation will be checked prior to and immediately after testing. Any abnormal responses to exercise will trigger medical review and deferred recruitment to the study. 3. Body weight greater than 150KG (The PACE equipment is CE Certified to support people weighing up to 150 KG. Weight will be checked during the baseline assessment. Any person weighing more than 150KG will be supported in accessing alternative physical activity options and nutritional advice) 4. Functional Ambulation Category less than 1 (People who are dependent on hoists or transfer aids to move between seated surfaces will not be eligible to join the study due to risk of injury to themselves or the research assistants) 5. Unable to follow verbal or non-verbal prompts or instructions (The ability to follow single-stage instructions which will be conveyed through a combination of verbal and non-verbal prompts with support from translators or carers as required will be assessed during the baseline assessment)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment measured using participant recruitment recorded according to referral source at baseline;Attendance measured using record of attendance, completion and drop out at continuous from baseline to follow-up assessment (0-10 weeks);Adverse events measured using adverse events; severity and frequency at continuous from baseline to follow-up assessment (0-10 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mobility measured using Timed Up and Go Test at baseline, 9 weeks;Mobility measured using 10 Metre Walk Test at baseline, 9 weeks;Cardiovascular fitness measured using resting heart rate and blood pressure at baseline, 9 weeks;Cardiovascular fitness measured using submaximal exercise test at baseline, 9 weeks;Quality of life measured using EQ-5D-L at baseline, 9 weeks;Quality of life measured using PROMIS Global Health Questionnaire at baseline, 9 weeks;Quality of life measured using Stroke Impact Scale at baseline, 9 weeks | — |
Countries
United Kingdom
Contacts
Public ContactSarah Wilkinson
Outcome results
None listed