School of Physiotherapy The University of Sydney Cumberland Campus Lidcombe

Health Promotion Unit (Eastern Zone) Sydney South West Area Health Service

Exercise intervention to prevent falls, enhance mobility and upper limb function and increase physical activity in community dwellers after stroke: A randomised controlled trial INFORMATION FOR PARTICIPANTS Introduction You are invited to take part in a research study of exercise after stroke. The project aims to establish and evaluate community-based exercise programs for people who have had a stroke. The exercise program will consist of a weekly exercise class plus a home program. The exercise classes will be held weekly at the Stroke Recovery Association NSW Stroke Clubs. The study is being coordinated at the University of Sydney and The Health Promotion Unit (Eastern Zone) of the Sydney South West Area Health Service. The study will be carried out at the Stroke Recovery Association NSW Stroke Clubs by Dr Catherine Dean, Senior Lecturer, School of Physiotherapy, The University of Sydney Associate Professor Chris Rissel, Director, Health Promotion Unit Sydney,South West Area Health Service Ms Michelle Sharkey, Executive Officer Stroke Recovery Association NSW Dr Catherine Sherrington, NHMRC Australian Research Training Fellow The University of Sydney Professor Robert Cumming, Professor of Epidemiology and Geriatric Medicine Centre for Education and Research in Ageing, The University of Sydney Study Procedures If you agree to participate in this study, you will be asked to sign the Participant Consent Form. A researcher will ask you some questions to ensure that it is safe and appropriate for you to participate and you will be given a medical clearance form for your doctor to complete. Once we have received this clearance, you will be placed at random (like tossing a coin) into one of two different exercise programs involving individualised weekly exercise classes and a home program. Your home program will be monitored and increased by the study physiotherapist. You will be provided with a written exercise program and log book. You will be asked to record in the log book the exercises completed and your response to exercise, including any muscle soreness or fatigue. The intervention will run over a 12 month period with 40 weekly exercise classes conducted during school terms. You will also be asked to attend two measurement sessions, one on entry to the study and the other after the 12 month study period. Each measurement session will take approximately 2 hours of your time and be conducted in your home or at your Stroke Club.

Page 1 of 4

School of Physiotherapy The University of Sydney Cumberland Campus Lidcombe

Health Promotion Unit (Eastern Zone) Sydney South West Area Health Service

Exercise intervention to prevent falls, enhance mobility and upper limb function and increase physical activity in community dwellers after stroke: A randomised controlled trial At the measurement session on entry to the study you will be asked to provide some background information about yourself, including the date of your stroke, and to undertake the following tests: A short assessment of the severity of your Stroke A short test of your mental ability (the Mini-Mental State Evaluation). At both measurement sessions you will be asked to complete the following tests: A falls risk profile, which involves a series of short tests of vision, sensation, muscle strength, balance and reaction time. The 10m walk speed test, which involves timing how long you take to walk 10 metres at both your preferred and fast walking speeds. The 6 minute walk test, which measures how far you walk in 6 minutes. The Adelaide Activities Profile: you will be asked some questions about your community participation in the last 3 months. The Nottingham Extended ADL and SF12 questionnaires: you will be asked some questions about how much help you need with your activities of daily living, like bathing, dressing, eating, etc. Items 6,7,8 of Motor Assessment Scale for Stroke which involves measuring your arm and hand function. The nine peg hole test which involves timing how long you take to place 9 pegs in 9 holes on a board. The letter cancellation task which involves timing how long it takes you to cross out all the h letters on a grid of letters. Mobility tests which will involve measuring your stepping, sit to stand, your ability to stand up from a chair walk 3 metres and return to the chair and also your standing. A physical activity test: you will be asked to wear a pedometer on 7 consecutive days to count the number of steps you take. The pedometer is a small device which is worn on your belt and will not inhibit your movement.

In addition to the two measurement sessions, you will be asked to complete a monthly falls and health utilisation calendar. If you have a fall or visit a health provider, you will be asked to mark it on the calendar. Each month you will post your calendar to the study coordinator in the reply paid envelope provided. If you have a fall, a researcher will telephone you to ask about the consequences of the fall. Costs Participation in this study during the 12 month study period will be free. After this 12 month period you will be able to continue the weekly exercise classes and may complete additional exercises (from the other groups program) which are deemed Page 2 of 4

School of Physiotherapy The University of Sydney Cumberland Campus Lidcombe

Health Promotion Unit (Eastern Zone) Sydney South West Area Health Service

Exercise intervention to prevent falls, enhance mobility and upper limb function and increase physical activity in community dwellers after stroke: A randomised controlled trial appropriate by the study physiotherapist. The cost of ongoing participation will be up to $ 8.00 per exercise class. Your ongoing attendance and fees paid will be analysed for a further 12 months in order to see whether provision of self-funded exercise classes through the Stroke Recovery Associations Stroke Club network is viable in the future. Risks The risks of participating in this study are likely to be discomfort associated with exercise. All the procedures outlined above are non-invasive. During the measurement sessions, you will be given rests between the tests. If you feel unsteady at any time, you should stop and the researcher will provide you with a chair to rest. Although it is unlikely, there is a small risk that participants could fall during an exercise class or while exercising at home. To minimise this risk, your exercise class will be conducted by a physiotherapist who will design and progress your program to match your abilities. Your home program will also be tailored to your abilities and you will be instructed in how to perform your exercises safely with stable objects nearby to hold onto when needed. The level of difficulty in the class and home program will only be increased by the physiotherapist when it is safe to do so. In the unlikely event of an injury occurring, you should seek medical advice and report the injury and the circumstances surrounding it to the research staff.

Benefits While we intend that this research study furthers medical knowledge and may improve treatment of people after stroke residing in the community in the future, it may not be of direct benefit to you. It is probable, however, that all participants will get the general benefits of regular exercise. In addition, with your permission your results from the two measurement sessions will be sent to your local doctor on completion of the study period. Compensation for injuries or complications If you suffer any injuries or complications as a result of this study, you should contact the study doctor as soon as possible, who will assist you in arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital. In addition, you may have a right to take legal action to obtain compensation for any injuries or complications resulting from the study. Compensation may be available if Page 3 of 4

School of Physiotherapy The University of Sydney Cumberland Campus Lidcombe

Health Promotion Unit (Eastern Zone) Sydney South West Area Health Service

Exercise intervention to prevent falls, enhance mobility and upper limb function and increase physical activity in community dwellers after stroke: A randomised controlled trial your injury or complication is sufficiently serious and is caused by unsafe drugs or equipment, or by the negligence of one of the parties involved in the study (for example, the researcher, the hospital, or the treating doctor). You do not give up any legal rights to compensation by participating in this study. Voluntary Participation Participation in this study is entirely voluntary. You do not have to take part in it. If you do take part, you can withdraw at any time without having to give a reason. Whatever your decision, please be assured that it will not affect your medical treatment or your relationship with the staff who are caring for you. In addition your relationship with the Stroke Recovery Association of NSW, The University of Sydney and Sydney South West Area Health service will not be affected by your participation or non participation. Sometimes during the course of a study, new information becomes available about the treatment that is being studied. While you are participating in this study, you will be kept informed of any significant new findings which may affect your willingness to continue in the study. Confidentiality All the information collected from you for the study will be treated confidentially, and only the researchers named above and research assistants will have access to it. The study results may be presented at a conference or in a scientific publication, but individual participants will not be identifiable in such a presentation. Further Information When you have read this information, Dr Catherine Dean will discuss it with you further and answer any questions you may have. If you would like to know more at any stage, please feel free to contact her on 9351 9266 or 0438 545 201. This information sheet is for you to keep. Ethics Approval This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney South West Area Health Service. Any person with concerns or complaints about the conduct of this study should contact the Secretary on 02 9515 6766 and quote protocol number X06-0039. Version No.4 Date:17/05/2006 Page 4 of 4