ACELA II

Swimming remains England’s most popular mass-participation sport, with an all-increasing interest in other water-based sports and fitness classes as well.

Despite their popularity, the effects of water-based exercise haven’t been studied in older adults, as extensively as those of the land-based sports. As a matter of fact, results have been mixed as far as their longer-term benefits are concerned. With this evidence in mind, we will attempt to bridge the knowledge gap and explore the cardiovascular health of people who: i) are over the age of 55, ii) have regular blood pressure, iii) are not currently exercising and iv) are willing to take up water-based exercise for a period of at least two months.

If you live in Sheffield and are interested in taking part, please read the information below.

What will happen if I take part?

We will contact you by phone or e-mail to answer any questions you may have about the study. We will then ask you questions about your medical history to check whether you can participate. You will be excluded if you have any medical conditions or if you are taking medications that will affect the measurements in the study. If you are a suitable participant, we will invite you to attend our assessment centre at Sheffield Hallam University on one occasion for two occasions (of about 90 minutes duration).

What will I be required to do?

We will arrange an appointment at a time that is best for you. You will be asked to abstain from caffeine consumption for 3h prior to the visit. You will arrive at the Collegiate Crescent Campus of Sheffield Hallam University on your assigned date and hour. You will have the opportunity to ask questions about the study and you will be asked to sign a consent form. A copy of the consent will be given to you and we will keep one for ours record.

You will be asked to complete a number of questionnaires, exploring your medical history and current lifestyle. We will then measure your weight, height, waist and hip circumference, using safe, non-invasive procedures. Next, we will assess your small vein function: measurements will take place in a temperature-controlled room at 22-24ºC. You will rest in a supine (lying on your back) position for 15 minutes, during which your heart rate and blood pressure are measured at 5-minute intervals. After the 15 minutes, a localheating disc (heated at 32ºC) and a probe are attached to your skin with an adhesion sticker, and a first measurement of skin blood flow will be recorded for 5 minutes. Following this, rapid local heating will begin and the temperature will be increased by 1 degree every 10 seconds until 42 degrees is reached. This will be then maintained for 20 to 25 minutes following. Then, the temperature of the probe will be quickly increased to 44 °C for a final 10 min to obtain maximal vasodilatation, after which the test will be completed.

Finally, we will assess how your large arteries are functioning. A blood vessel in your upper arm will be imaged using ultrasound whilst a blood pressure cuff is inflated around your forearm for 5 minutes. Inflation of the cuff may result in a “pins and needles” sensation in the fingers, but this will go away when the cuff is released. Once the cuff is deflated arterial scanning will be maintained for a further 5 minutes.

At the end of your first visit, you will receive – with our compliments – a pass that will allow you to have free access in one of the pool that we collaborate (Concord Sport Centre, Heeley Pool and Gym, Hillsborough Leisure Centre, Ponds Forge, Springs Leisure Centre, Westfield Sports Centre) for a period of 2 months. We will ask you to visit one of these venues and take advantage of the pool-based classes or swim for at least twice per week for two months. Once this period is completed, we will invite you to repeat the assessments of the first visit. Following that your participation in the study will be completed, although you may wish to continue exercising at your own expense.

What are the possible benefits of taking part?

For those who are already exercising, there are no specific direct benefits of taking part in the study, although you may be interested to know your body composition and also receive an indication of your small veins’ and arterial health. For those who don’t but will start, there is the possibility that they will see their fitness and agility improving. In both cases, knowledge gained from this study will help our research into the understanding how regular, water-based sports may affect cardiovascular health in older healthy adults.

What are the possible disadvantages and risks of taking part?

During assessments you may feel embarrassed during the measurement of body composition level. This is perfectly normal – if that happens please let a member of the research team know, so that these are terminated. Finally, the localized heating of 42 ºC may make you feel uncomfortable if you have sensitive skin or the inflated cuff may make you feel uncomfortable, as the blood supply in your arm is reduced. If that happens, please let a member of the team know so that the test is stopped.

All the possible negative consequences mentioned above are expected to disappear minutes after the tests are completed without consequences. If you are not exercising and decide to take advantage of the free pass, it might be possible that you will feel tired after a fitness or swimming session. However, as these will take place at your own leisure, time and pace you may stop and rest at any time. In any case, we would like to emphasise that you may withdraw from the study at any moment.

Are there any expenses or payments involved?

You will receive a complimentary pass for the pool area in one of the Leisure Centres that we we collaborate with, for a 2-month period. This includes free swimming as well as pool-based fitness classes. Additionally, we will arrange a free permit for on-site parking should you choose to drive to Collegiate Crescent. No other expenses however, will be paid.

If I decide to participate, will my GP be notified?

We don’t plan to contact your doctor about your participation in the study, however, we would encourage you to do so, if you would like an independent, medical opinion about taking part.

What if I change my mind during the study?

You are free to withdraw from the study at any time. We would like to use all of your data up to the point of withdrawal as this will help with our analysis. However, if you would prefer us not to use any of your data you may request for all of your data to be removed from the study. A decision not to carry on with the study will not affect the quality of medical care you receive in any way.

Will anyone be able to connect me with what is recorded, collected and reported?

Sheffield Hallam University will collect information from you in accordance with the Research Ethics Committee’s instructions. Sheffield Hallam University will use your name, gender, date of birth, contact details confidentially to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Individuals from Sheffield Hallam University and regulatory organisations may look at your research records to check the accuracy of the research study. The only people in Sheffield Hallam University who will have access to information that identifies you will be people who need to contact you to audit the data collection process. The people who analyse the information will not be able to identify you and will not be able to find out your name or contact details. Sheffield Hallam University will keep identifiable information about you from this study for 7 years after the study has finished.

What will happen to the information from the study?

It is anticipated that the results of the study will be presented at scientific meetings and published in a scientific journal. The overall results will be available to you; however, it will not be possible to provide you with an individualised report of your performance.

What if there is a problem?

Any complaint about the way you have been dealt with during the study or any possible harm you might have suffered will be addressed.

When will I have the opportunity to discuss my participation?

If you would like more information about the study at any point, you are invited to contact:

Dr Markos Klonizakis Sheffield Hallam University Tel 0114 225 5697.

You should contact the Data Protection Officer if: i) you have a query about how your data is used by the University, ii) you would like to report a data security breach (e.g. if you think your personal data has been lost or disclosed inappropriately), iii) you would like to complain about how the University has used your personal data [email protected].

You should contact the Head of Research Ethics (Professor Ann Macaskill) if: you have concerns with how the research was undertaken or how you were treated [email protected].

Postal address: Sheffield Hallam University, Howard Street, Sheffield S1 1WBT

Telephone: 0114 2255555.

What if I am harmed?

In the event that something does go wrong, and you are harmed during the research study, unfortunately, there are no special compensation arrangements. Nevertheless, if you are harmed as a result of someone’s negligence then you may have grounds for legal action for compensation, but you may have to pay your legal costs.

Who is organising and funding the research?

This study is being funded by Sheffield Hallam University and is supported by Sheffield International Venues. Sheffield Hallam University is also responsible for the conduct of the study. The investigators of this study will not receive any payment for conducting this research.

Legal basis for research for studies

Sheffield Hallam University is the sponsor for this study based in the United Kingdom. We will be using information from you and/or your medical records in order to undertake this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Sheffield Hallam University will keep identifiable information about you for 7 years after the study has finished. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally identifiable information possible. You can find out more about how we use your information at https://www.shu.ac.uk/about-this-website/privacy-policy/privacy-notices/privacy-notice-for-research. However, all clinical research is reviewed to ensure that participants are treated appropriately, and their rights respected.

This study was approved by UREC with Converis number ER5560707. Further information at https://www.shu.ac.uk/research/ethics-integrity-and-practice.

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