Call for Participants of 65 or over for a Study at the University of Southampton. Study Title: Elder Athletes – Assessment of an at-home incidental interaction intervention. Participant information below

“Participant Information Sheet

Study Title: Elder Athletes: Assessment of an at-home incidental interaction intervention

Researcher: Dr Isobel Thompson

ERGO number: 99702

You are being invited to take part in the above research study. To help you decide whether you would like to take part or not, it is important that you understand why the research is being done and what it will involve. Please read the information below carefully and ask questions if anything is not clear or you would like more information before you decide to take part in this research. You may like to discuss it with others, but it is up to you to decide whether or not to take part. If you are happy to participate you will be asked to sign a consent form.

What is the research about?

We are a group of academic staff at the University of Southampton, interested in increasing the physical activity levels and strength of elderly individuals in their homes. We have developed two systems designed to encourage older adults to move more in their home environments: the Chair System and the CanBand.

The Chair System: This sensor-based system attaches to any chair, encouraging the user to ‘do it twice’ – turning the act of sitting and standing into an effective exercise for improving lower body strength, balance, and physical activity levels. It’s an easy way to stay active using everyday movements without adding extra time or equipment.

The CanBand:

The CanBand attaches to any can in your cupboard, transforming it into a tool for enhancing upper limb strength, grip, and mobility. It’s a fun and convenient way to improve upper body fitness during daily tasks.

Both systems are designed to be incidental, simply encouraging the repetition of movements that the user would already be completing daily. The research team has developed the system alongside our target population but needs to test the effects of the system when deployed within people’s home environments.

Why have I been asked to participate?

You have been asked to participate in this feasibility testing study because you are an English-speaking adult over the age of 65 years of age. Males and females, with an interest in aiding the development of an at-home intervention to improve physical activity levels, are eligible to participate. Participants should have sufficient physical capacity to complete the activities outlined and should score six or below on the clinical frailty score.

Adults without sufficient mental capacity to provide consent, or those with a neurological impairment or musculoskeletal condition limiting function will not be eligible to participate. We are interested in recruiting individuals who would consider themselves as sedentary.

In total, we will recruit 20 individuals to participate in this study.

What will happen to me if I take part?

This study is designed to assess the effects of our systems when they are used in people’s home environments. The study will involve a four-week deployment of both systems within your home. The study can be split into three key stages as follows:

1. Pre-intervention assessment

A suitable time will be arranged for you to either (a) visit the Health Sciences research laboratory or (b) have the researchers visit your home, where initial health and strength assessments will occur. The session will not last longer than 1 hour. This will include basic functional tests such as sit-to-stand, as well as measures of leg strength and muscle function. More details on the testing protocols are provided below (Pre and Post-Intervention Assessment section).

2. At home-intervention

Following the initial assessment, the research team will visit your home and set up the systems for testing as soon as possible. The technologies will be in place in your home for four weeks. You will be encouraged to continue to participate in any fitness classes or prescribed exercise interventions that you are currently enrolled in.

3. Post-intervention assessment

Once the four-week at-home intervention is complete, a suitable and convenient time will be arranged for you to (a) complete a return visit to the Health Sciences research laboratory, or (b) for the

research team to visit your home. The same battery of testing will be carried out as above in stage one, to measure any change in muscular strength following the four-week intervention. You will be asked to complete an anonymous survey related to your personal experience using the systems over the four week deployment in your home.

Pre and Post-Intervention Assessment

a) Five times sit-to-stand test. You will start in a seated position. You will be asked to stand up and sit down five times in a row, as quickly as you are able to.

b) Myoton measurement. You will comfortably lie on your back. A small handheld device will apply a small, painless tap to the thigh muscle.

c) Leg strength test. You will be seated in a chair. A small device, called a handheld dynamometer, will be held against your lower leg while you exert a maximal force against it. This measurement will be completed on both the front (pushing your lower leg forwards) and back of the lower limb (pushing your leg backwards).

d) Ultrasound scan of the thigh muscle. You will comfortably lie on your back, and the researcher will apply a small amount of gel to your skin to help the probe take clear pictures. The probe will be gently moved over the skin surface. The process should take no longer than 10 minutes, after which the gel will be removed from your leg.

e) Timed up and go test. You will start in a seated position. You will stand up on the researcher’s command, walk 3 meters, turn around, walk back to the chair and sit down again.

Are there any benefits in my taking part?

You will be offered a £60 Amazon voucher upon completion of the four-week intervention, as a thank you for your time and participation. You will be helping with designing a system which will ultimately be deployed within individuals’ homes to increase physical activity levels.

Travel expenses can be reimbursed if you need to travel to the University.

Are there any risks involved?

There are no serious risks involved in your participation. You may find the protocols to be fatiguing. You will be asked to confirm that you have sufficient physical capacity to undertake the tasks outlined above before data collection begins.

What data will be collected?

Personal data (emails and signed consent forms) will be collected at the beginning of the study by the lead researcher. Emails will be used to send you the participant information sheet, answer any questions you might have, and arrange a suitable time for data collection. Your email address will only be stored if you give optional consent to be recontacted for future research studies. Your email address will be stored in a password-protected spreadsheet, only accessible to the research team. Signed consent forms will be stored in a locked cabinet in the office of the lead researcher.

Strength and health-related parameters collected during pre and post-intervention assessments will be stored in a spreadsheet on the lead researcher’s University of Southampton One Drive account. This spreadsheet will not include identifying data, and will only be accessible by the research team.

Will my participation be confidential?

Your participation and the information we collect about you during the course of the research will be kept strictly confidential. Retained data (consent forms and electronic data) will be stored as outlined above, in accordance with University of Southampton recommendations.

Only named members of the research team and responsible members of the University of Southampton may be given access to data about you for monitoring purposes and/or to carry out an audit of the study to ensure that the research is complying with applicable regulations. Individuals from regulatory authorities (people who check that we are carrying out the study correctly) may require access to your data. All of these people have a duty to keep your information, as a research participant, strictly confidential.

Do I have to take part?

No, it is entirely up to you to decide whether or not to take part. If you decide you want to take part, you will need to indicate this to the lead researcher by emailing i.m.thompson@soton.ac.uk or by phoning 023 8059 6616. You will need to sign a consent form to show you have agreed to take part.

What happens if I change my mind?

You have the right to change your mind and withdraw at any time without giving a reason and without your participant rights being affected. To withdraw, you can speak to the lead researcher or contact them on i.m.thompson@soton.ac.uk or by phoning 023 8059 6616. Anonymous data cannot be withdrawn after it has been submitted.

If you withdraw from the study, we will keep the information about you that we have already obtained for the purposes of achieving the objectives of the study only.

What will happen to the results of the research?

Your personal details will remain strictly confidential. Research findings made available in any reports or publications will not include information that can directly identify you without your specific consent.

Where can I get more information?

If you would like any further information, or have any questions relating to this study, please contact the research team via email at i.m.thompson@soton.ac.uk or on the phone at 023 8059 6616.

What happens if there is a problem?

If you have a concern about any aspect of this study, you should speak to the researchers who will do their best to answer your questions. The lead researcher can be contacted at i.m.thompson@soton.ac.uk or on 023 8059 6616, or the project lead at mc@ecs.soton.ac.uk or on 023 8052 8372.

If you remain unhappy or have a complaint about any aspect of this study, please contact the University of Southampton Head Research Ethics and Governance (023 8059 5058, rgoinfo@soton.ac.uk).

Data Protection Privacy Notice

How will we use information about you?

For the purposes of data protection law, the University of Southampton is the ‘Data Controller’ for this study, we will need to use information from you for this research project. This information will include your name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead, which can be used to link your data across the three stages together (linked anonymity). We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

In line with the University of Southampton’s Research Data Management Policy, all significant research data will be held for 10 years after study completion, after which time it will be destroyed.

What are your choices about how your information is used?

· You can stop being part of the study at any time, without giving a reason.

· We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.

· If you agree to take part in this study, you will have the option to take part in future research using your contact details saved from this study. These will be stored in a password-protected spreadsheet in a secure University of Southampton cloud account, which only the research team will have access to. This data will only be accessed when recruiting for future studies.

Where can you find out more about how your information is used?

You can find out more about how we use your information:

· The Human Regulatory Authority (HRA) protects and promotes the interests of patients and the public in health and social care research, More information can be found at www.hra.nhs.uk/information-about-patients/

· The leaflet available from [www.hra.nhs.uk/patientdataandresearch]

· by sending an email to University’s Data Protection Officer (data.protection@soton.ac.uk).

· by asking one of the research team or from our general privacy policy.

· by sending an email – Contact Dr Isobel Thompson, PhD:  I.M.Thompson@soton.ac.uk
Research Fellow & Senior Technical Manager | School of Health Sciences, Faculty of Environmental and Life Sciences

Thank you.”