What is the project about?

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• In this study, we compare usual daily living to a balance and mobility program to see which is better for

  • physical health and quality of life and whether it can reduce ​​

  • cognitive decline and falls and

  • what the associated costs are.

• Balance training helps older people without memory issues to prevent falls, but it is unclear whether improving balance can help people with mild cognitive impairment.

• This study will test this in a group of 396 adults (aged 50+ years).

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Who is doing the research?

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This project is being conducted by a team of experts, including Dr Elissa Burton PhD, Professor Anne-Marie Hill PhD, Associate Professor Rachael Moorin PhD, Associate Professor Joanne McVeigh, Mrs Angela Jacques (Curtin University), Professor Keith Hill PhD (Monash University), Professor Nicola Lautenschlager PhD, Associate Professor Kathryn Ellis (University of Melbourne), Professor Kirk Erickson PhD (University of Pittsburgh), Ms Meg Lowry Physiotherapist (Next Step Health).

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We also have a number of health professionals involved including 

• Geriatricians: Clinical Associate Professor Roger Clarnette (Fremantle Hospital), Dr Joel Tate (Armadale Hospital), Dr Sarah Bernard (Sir Charles Gairdner Hospital)

• Neurologist: Dr Carolyn Orr (Royal Perth Hospital)

• Physiotherapists: Luke Bongiascia (Rockingham Hospital)

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Is there a cost involved?

• No, there is no cost involved and you will not be paid to participate in the research

• The project is funded by the Australian National Health and Medical Research Council and Curtin University.

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Why am I being asked to participate and what do I have to do?

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• You are being asked to take part because you have memory issues or mild cognitive impairment which we are interested in studying and helping to improve your health

• For each participant the study will take 12 months overall and your participation will involve the following:

  • Conversation over the phone with our Research Officer where we will ask you questions about your age, health, memory and things like activity levels​ and how much alcohol you drink 

  • After answering these questions our Research Officer will also ask to meet you and a family member to ask a few more questions to help us work out if you are eligible for the study. If you are we will ask you to sign a consent form. We will also ask you to provide permission for us to access your Medicare and Pharmaceutical Benefits Scheme items for the 12 months before and during the study, as this information will allow us to compare costs between the two groups

  • The Research Officer will then take you through some physical tests (e.g. walking and sitting and standing balance exercises) and ask you some questions about your health. This will take around 60-90 minutes. These same tests will be conducted again in 6 and 12 months time

  • Each time we do these tests we will also ask if you would like to wear an accelerometer for one week to see how active you are. We will come back 8 days later and pick it up from you

• After completing these tests and questions the first time, you will then be randomly allocated (like the flip of a coin) to either the balance and mobility group or the group that receives health promotion and is asked to continue with your usual care and activities. You will have 50% chance of being allocated to either group

• The participants allocated to the usual care group have a very important role because the outcomes gained by this group will set the bar to know whether the balance and mobility program is any better or not. At the end of the study we will also provide you with an opportunity to receive the balance and mobility program

• Every participant in the study will receive a phone call each month asking how physically active you have been and whether you have had any falls

• If you are allocated to the balance and mobility group a physiotherapist will come out to your home (or a place of choice) six times and will speak on the phone with you 4 times over the first 6 months. Each home session will last approximately 30-60 minutes and the phone calls approximately 15-20 minutes. These sessions will be organised at a time that is convenient for you. You will be asked to participate in the balance and mobility program for 24 weeks, at your convenience.

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How much time is required for participation in the study?

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For participants in the usual care group: initial phone call and completion of first physical tests = approximately 2 hours. Monthly phone calls = approximately 5 mins per call, 1 hour over 12 months and the other two physical tests at 6 and 12 months (approximately 1 hour each). Picking up accelerometer 3 times (10 minutes per occasion) = 30 minutes. So, total time approximately 5.5 hours over 12 months.

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For those allocated to the balance and mobility group the same amount as the usual care group plus the physiotherapy visits (6 visits of approximately 45 mins each) and phone calls (4 calls approximately 15 mins each). So the total time would be 11 hours over 12 months.

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Are there any benefits to being in the research project?

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• If randomised to the usual care group, you will be greatly helping the study by your experience setting the benchmark by which we will know whether the mobility and walking program being studied is any better or not. Without this, our study would not be possible

• If randomised to the mobility and walking group you will receive visits from qualified physiotherapists who have taken extra training to be part of the study

• We anticipate the results of this research will help us to:

  • better understand about how to improve health and reduce falls for people with mild cognitive impairment​

  • inform health professionals about better ways to prevent falls and improve physical function for people with the same health condition as you

  • inform future research for helping people with mild cognitive impairment

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Are there any risks, discomforts or inconveniences from being in the research project?

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• Participants will require some time commitment depending on which group you are allocated to

• The physical tests involve some physical activity, these are routine tests and the risk of taking part is minimal

• Those in the balance and mobility group will be asked to participate in the balance and mobility program, the physiotherapist will start you at a level appropriate to you, but there is always a small risk of feeling side effects or experiencing an injury while participating

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Who will have access to my information?

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• Any information collected in this research study that can identify you will be kept confidential and be de-identified (so your identity will not be known). Only the research team will have access to the data. The only people who will have access to your information are the research team (and the Ethics Committee at Curtin University if they choose to audit the study)

• All data will remain in Australia

• Electronic data will be stored on a password protected folder at Curtin University and any hard copy data will be kept in a locked cabinet in the office of Dr Elissa Burton at Curtin University, Bentley WA

• Data collected by Curtin University study staff (i.e. Research Officers and Physiotherapists) will be stored on a secure network for 25 years. Data provided from the WA Data Linkage Branch and Services Australia will be stored for 7 years after publication

• The results of this research study may be presented at conferences or published in professional journals but you will not be identified in any results that are published or presented

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Will you tell me the results of the research?

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Yes. At the end of the project and once we have calculated the results we will inform you of the publication of the main results of the study

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Do I have to take part in this research study?

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Taking part in this study is completely voluntary. It is your choice to take part or not. If you do take part you can change your mind at any time and withdraw. This will not affect your relationship with the researchers or if you heard about the study from a health professional it will not affect your relationship with them either. If you do want to stop just tell us, you do not need to give a reason. If you do leave the study, you will be able to choose whether the study will destroy or retain the information it has collected about you. If data have already been de-identified it will not be possible to not use it.

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Has the study received Human Research Ethics Approval?

 

South Metropolitan Health Service (SMHS - RGS3930), the Western Australian Department of Health (WA DoH - RGS3930) and Curtin University (HRE2020-0378) Human Research Ethics Committees have all approved the research study. 

 

Curtin University is responsible for the research project which it is conducting independently of any hospitals and the Government of Western Australia.

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What happens next and who can I contact about the research?

 

If you have any questions about the research study please call Dr Elissa Burton on (08) 9266 4926 or email balanceonthebrain@curtin.edu.au for more information, to ask questions or to participate.

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Click here to download the full Participant Information Sheet and Consent Form
 

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