Participant Information Sheet

If you would like to watch and listen to Dr Dan Gordon talking about the project and what you would have to do, then please click here:

Digital Participant Information sheet

Section A:  The Research Project

Title of project

The benefits of prescribed exercise on the physical and cognitive health of persons with Down syndrome

Purpose of study

The aim of this study is to gain an understanding of how exercise and physical activity such as walking and jogging can benefit the physical and mental health of persons with Down syndrome. 

Who are the researchers? 

Lead Researcher: Associate Professor Dr Dan Gordon. Anglia Ruskin University, Cambridge, UK (dan.gordon@aru.ac.uk)

Research Assistant: Miss Viviane Merzbach. Anglia Ruskin University, Cambridge, UK (viviane.merzbach@aru.ac.uk)

Why have I been asked to participate?

We are looking to recruit participants who have been diagnosed with Down syndrome and who are aged 18 years or above and have access to a personal computer/laptop and a mobile phone.

How many people will be asked to participate?

We will aim to recruit around 200 participants.

Do I have to take part?

You are under no obligation to take part; you are free to withdraw from the study at any time and are not required to provide a reason for doing so.

Has the study got ethical approval?

The study has been granted ethical approval from the Faculty of Science and Engineering Research Ethics Panel, Anglia Ruskin University, Cambridge, UK.

Legislation relating to this study

The data we will collect from you will be handled and stored according to the General Data Protection Regulations (2018).

Source of funding for the research, if applicable

This study has received funding through the Canadian Down Syndrome Society (CDSS).

What will happen to the results of the study?

The results from this study will be written up as a summary document. The information (all anonymous) will be passed to FCB Toronto, who are creating a marketing campaign around physical activity benefits in the Down syndrome population. In addition, these findings will be submitted to the Canadian Down Syndrome Society (CDSS). Finally, the results will be written up for publication in a peer-reviewed journal.

Contact for further information

Lead Researcher: Dr Dan Gordondan.gordon@aru.ac.uk

Research Assistant: Miss Viviane Merzbachviviane.merzbach@aru.ac.uk

 

Section B:  Your Participation in the Research Project

What will I be asked to do?

Once you have read this information sheet, you will be asked to provide consent to participate.  This will be done electronically, and we are asking you to read the information sheet carefully before agreeing to take part. Once you have consented, you will be asked to complete what is called a pre-exercise medical form. This is nothing to worry about, but we use it to make sure that you are fit and healthy to take part in this study. We will ask you a few more questions about for example your physical activity habits. Please do ask for help from your caregiver, support worker, or parents if needed when filling in these forms. It is very important that all the information you provide us with is correct. We will also ask you for your email address, please do make sure that you enter this correctly as we will need to use this to keep in contact with you during the study.  Once you have done all of this, we will send you details of how to download some apps to your mobile phone, tablet, or computer.  We will use these apps to work with you during the study.  We will also send you through the mail a device called a Fitbit. This is a watch that allows us to monitor your physical activity throughout the study. 

Baseline measurements: Wearing the Fitbit on your wrist, you will need to walk as far as you can in six minutes. This test is called the 6-minute walk test. You need to do this test somewhere outdoors that is safe (away from busy roads), well-lit and as flat as possible. A support person should be walking with you for this test. The aim of this test is to walk as fast and far as you can in six minutes, which will help us assess your current fitness level.  We will send you instructions to help you set up the watch and make sure it is recording when you are walking. On a separate day, we will ask you to complete a survey with a series of mental challenges with the help of your parent, caregiver or support worker. These are like mini quizzes and are designed to be fun.  This can be done on a personal computer or laptop and will take around 30-40 minutes in total to complete but you can take some breaks in between the tests. For the baseline assessment, we will also ask you to complete a quick questionnaire called Profile of Mood States (POMS) questionnaire.

The actual study: Once the baseline tests are completed, we will put you into one of four groups. We are going to randomly assign you to one of the four groups. The four groups are:

 

Control Group:     

You do nothing new, you just do what you normally do in your day-to-day life.

Exercise Group:                   

30 minutes of walking/jogging 3 times a week for 8 weeks.

Cognitive Group:                 

20 minutes of brain training with BrainHQ 6 times a week for 8 weeks.

Exercise + Cognitive Group:          

Same as both the Exercise and Cognitive groups, that is 30 minutes of exercise 3 times a week for 8 weeks and at the same time 20 minutes of brain training with BrainHQ 6 times a week for 8 weeks.

 

If you are in the exercise, cognitive or exercise + cognitive groups, you can choose when during the week you complete your tasks.  Just remember that you MUST stick to the requirements of each group.

If you are in the exercise or exercise + cognitive group, we would like you to do another little test for us.  We want you to get used to how fast you should be going during the walking or jogging exercise.  So, to do this, we will ask you to go outside and walk with someone. You will start walking for 3 minutes, while you walk, we want you to sing Happy birthday to whoever is with you in the last 30 seconds of the 3 minutes. After these 3 minutes, if you were able to sing comfortably, we want you to walk a little faster but sing again at the end of the 3 minutes.  Keep repeating this walking a little faster after each 3-minute stage until you find it hard to keep singing, you should feel that your breathing is interfering with the singing. You may find that you have started to jog or even run before this starts to happen, that is fine. When this happens stop. Do not take breaks between the 3-minute stages, this is a continuous test that gets harder with each new stage. We want you to think how you felt during that final 3-minute stage when you could not sing comfortably.  Remember this, this is TOO HARD for the weekly exercise, do not go this fast.  We will remind you of the intensity throughout the study. Once you have completed 8 weeks of exercise, we will ask you to repeat this test one more time.

If you are in the cognitive and exercise + cognitive group, you will also need to complete what is called a cognitive check-in as part of your training at the very beginning of the brain training and after completing 8 weeks of brain training. For this, you will log in to your individual BrainHQ account, which we will set up for you, and play a series of games. These are the same games you will be playing for your 8 weeks of brain training. If you are in the control or exercise group, you will also complete the cognitive check-in through BrainHQ before and after the 8 weeks.

For all groups (control, exercise, cognitive, and exercise + cognitive), we will ask you to complete the POMS questionnaire once every week during the 8-week intervention. 

Final measurements: Once the 8-week period has been completed, we will ask you to repeat the same tests that we did with you at baseline, that is the 6-minute walk test, the mental challenges and the POMS questionnaire. 

In relation to this specific research project, we need to make you aware of the following:

We are responsible for the personal data you give to us as a:

Data Controller

(We are in sole control over the research)

Who are we?

Dr Dan Gordon on behalf of Anglia Ruskin University, Cambridge, UK

Joint Controller

(Where ARU and another organisation are working together on research)

with:

Canadian Down Syndrome Society and FCB Toronto

We will be asking you for the following information:

Personal Data:

Name and contact details

Age

Address

Sensitive and Personal Data:

Health

 

What will happen to your data?

Your data will be pseudo-anonymised. What does this mean? It means that although we collect your name, date of birth and address, we will also assign you a unique code, this code will be made up of letters and numbers. However, once the study is completed, we will detach all your data from your personal details.  As such beyond this point, we will not be able to retrieve any of your personal data from the study. You will from this point only be identifiable from the unique code.  All the data that we collect will be stored on a secure cloud platform only accessible to the lead researcher and the project research assistant.  The anonymised data will be combined to make a group output. This data will then be shared with both the Canadian Down Syndrome Society and FCB Toronto.

Will I receive any payment to take part in the research?

As part of this study, we will send you a Fitbit device. This is like a smart watch and we will use this with you to record the data. As way of thanks for taking part in this study, you will be allowed to keep the Fitbit.

Are there any possible disadvantages or risks to taking part? 

If you are in the exercise or exercise + cognitive groups, you may feel a little tired after each 30 minutes of exercise. You may also start to get bored of doing the exercise, if this is the case, we will recommend changing your route or exercising with a buddy for company. If you are in the cognitive or exercise + cognitive groups, you may get fed up with the brain training.  These tests are designed to be fun and will only take 20 minutes each day.  We will make sure that we offer a range of these to keep you excited.

What are the likely benefits of taking part? 

We hope that you get some enjoyment out of being part of the study. You will be helping with the development of an app, which is aimed at people with Down syndrome, and with the available support for people with Down syndrome.

Can I withdraw at any time, and how do I do this? 

You can withdraw from the study at any time and without giving a reason.  If you do not wish to continue, you can just let us know via email.  If you do withdraw, it may be possible to remove all your data. However, this will only be possible up until 6 weeks after the end of your participation, at which point we will remove all the personal information and so will no longer be able to identify your personal data.

What will happen to my data?

Our general privacy notice explaining our use of your personal data for research purposes is available here:

https://www.anglia.ac.uk/privacy-and-cookies/research-participants

Please visit this link for information about how long we keep your data, how we keep your data secure, how you can exercise your rights over your data, and make a complaint over our use of your data.

Can I withdraw my data from the study?

We can only remove your data if you ask us before we anonymise it.  After this, we will not know, which is your data so will not be able to do this.  We will be able to remove your data up to the point when we start to analyse it, which will be approximately 6 weeks after the end of your participation.

Whether there are any special precautions you must take before, during or after taking part in the study

For the mental training test, please ensure that you have a working computer or tablet/phone with internet connection and that they are charged. For when you are using the Fitbit to record exercise, you will need to be carrying the mobile phone with the Fitbit app installed on it. For the 6-minute walk test, please ensure that you have had a good meal, but no closer than 3 hours before exercising. For any of the exercise tests, please make sure you are wearing appropriate clothing to exercise in outdoors and that you try and always exercise somewhere close to home and with a buddy.

Summary of research findings

A summary of the research findings will be made available to all participants upon request or through the Canadian Down Syndrome Society.

Contact details for complaints

If you have any complaints about the study, you are encouraged to speak to Dr Dan Gordon (dan.gordon@aru.ac.uk) in the first instance to try and reach an informal solution.  Should you wish to however, you can also contact Anglia Ruskin University’s complaints procedure via:

Email address: complaints@aru.ac.uk

Postal address: Office of the Secretary and Clerk, Anglia Ruskin University, Bishop Hall Lane, Chelmsford, Essex, CM1 1SQ, UK.

 

 

Date 16.06.21

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