Without Parkinsons

Comparing the effects of dance and traditional exercise in people with Parkinson’s and community dwelling older adults: A feasibility study

Participant Information Sheet

You are being invited to take part in a research study. Before you decide whether or not to take part it is important that you understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish. Please ask us if there is anything that is not clear or if you would like more information. Thank you for reading this.

What is the purpose of the study?

This study aims to assess the feasibility and acceptability of conducting a trial comparing the effects of two physical activity programs for people with Parkinson’s: Dance for PD®, a popular dance program for people with Parkinson’s, and Traditional Exercise. To do this, we will evaluate recruitment success, attendance, adverse events, and the subjective experience of participating in the program. We will also measure the effects of the two programs on balance, thinking, symptoms of depression, fear of falling, and quality of life. Our goal is to better understand the effects of the two programs and how we can best go about measuring their effectiveness.

Why have I been chosen?

You have been asked to participate in this study because we are specifically interested in understanding the effects of dance and traditional exercise on people with Parkinson’s and older adults without Parkinson’s, namely partners and carers. Thus, we will recruit from the community 30 carers, family members, and similarly aged adults who don’t have Parkinson’s to serve as our control group. A “control group” will allow us to draw comparisons between people with and without Parkinson’s when evaluating the effects of the two programs. We also aim to see if any benefits extend to older adults without Parkinson’s, as they often participate in these programs alongside their family members. You have been identified either by a local community organization, such as Parkinson’s UK, or you responded to an advertisement.

Do I have to take part?

No. It is up to you to decide whether or not to take part. If you decide to take part, you will need to fill out the screening questionnaire to determine if you are eligible and you will be asked to sign a consent form, both of which have been included in this package. If you choose to take part but later change your mind, you can withdraw from the study without giving a reason at any time. A decision to withdraw will not affect the standard of care you receive. After the dance/exercise classes begin, you will not be able to withdraw your data from the study due to our chosen method of analysis.

 What will happen to me if I take part?

If you choose to take part in this study, you will be randomly assigned to one of the two groups: dance or exercise. It is important that we randomly assign you to a group, rather than letting you choose your group for yourself, because this will ensure that the groups are balanced and reduce the risk of bias in our results. Please note that we will notify your GP of your decision to take part in our study in the event that he/she has any questions or concerns.

You will then be asked to come to the balance laboratory at the David Keir Building at Queen’s University Belfast (QUB) to complete assessments before the intervention begins. During this testing session, we will measure balance, thinking, and symptoms of depression. This will take approximately two hours. We will also give you questionnaires to fill out; these will ask questions about your experience of fear of falling and quality of life.

Please be aware that we will video the portion of the assessment session that evaluates mobility in order to monitor safety and quality. Only the members of the research team (Anna Carapellotti, Mihalis Doumas & Matthew Rodger) will have access to this video and it will be destroyed within one year of the commencement of the study.

After your first assessment session, you will be asked to participate in 20 one-hour sessions of dance or exercise over the course of 12 weeks, an average of two classes per week. If you are unable to complete 20 classes in 12 weeks, you will be withdrawn from the study. If you wish to take part but have concerns as to whether or not you will be able to complete the required number of classes, please contact the research team and they will do their best to accommodate any scheduling conflicts. If you are withdrawn from the study but wish to continue taking dance/exercise classes, the research team will assist you in making alternative arrangements.

The classes will be held on Tuesdays and Thursdays at QUB’s Physical Education Centre: Botanic Park, Stranmillis Embankment, Belfast BT9 5EX beginning the week of September 3, 2018 and concluding the week of November 26, 2018. Classes will take place from 11:30-12:30 OR 1:30-2:30. You will be assigned to one of these timeslots if it is determined that you are eligible to participate in the study.

Sport NI are providing funding for this study as a part of their Everybody Active 2020 campaign so you will be asked to fill out a registration form and consent form on the first day of class so that Sport and NI and Belfast City Council can monitor the impact of our dance and exercise programmes. This will involve sharing your contact details and disability status with Sport NI; all information that you provide will be treated as confidential in line with relevant data protection legislation. We will take care of securely returning these forms to Sport NI for you.

It is important that you check your calendar and let us know in advance if and when you will need to miss any classes. During the course of the program, we will ask you to continue with your usual routine. We will also ask you to record in a diary the amount of exercise you are engaging with outside of the intervention, adverse events that occur outside of class (falls, muscle soreness, etc.), and any changes in your medication schedule. We will monitor any changes in treatment and adverse events weekly in the form of a questionnaire.

After you have completed 20 sessions of your assigned program, you will return to the laboratory to complete the assessments once again so that we can measure any physical, mental or emotional changes. You will also complete the questionnaires again, and you will be given an Exit Questionnaire that asks about your experience in the dance or exercise classes. Please note that direct quotations from your responses to the open ended questions in the Exit Questionnaire may be used in publication; these quotations will be anonymized so that you cannot be identified. The Exit Questionnaire can be completed at home if you prefer in order to reduce the amount of time spent in the lab.

Lastly, two months after the classes have finished, you will complete all of the tests (physical and mental) and questionnaires one last time; this will allow us to measure any long-term effects.

What are the possible risks or disadvantages of taking part?

The main disadvantage to taking part is that you will have to give up some of your time to complete the assessments and to participate in the classes. Taking part in this study may make you ineligible for participation in other research. You should consult with the research team prior to enrolling in another study.

There is also a small risk of muscle soreness or injury associated with taking part in any exercise program or physical assessments. We can assure you that these classes have been carefully designed for people with Parkinson’s and older adults, and the instructor has been appropriately trained. The appropriateness of all laboratory assessments has also been confirmed through previous research.

If you experience a medical issue during one of the dance or exercise classes, your instructor, who is a qualified first aider, and Queen’s Sport Team Leader/Operations Manager will assess the situation in accordance with First Aid Training and ensure that you receive the appropriate care. Three qualified first aiders in addition to your instructor will always on site at the Physical Education Centre during the intervention.

What are the possible benefits of taking part?

By taking part in this study, you will help the Parkinson’s community better understand the effects of different types of exercise on mobility and quality of life in people with Parkinson’s and older adults. You will also help researchers and practitioners better understand how to design exercise programs and interventions so that they are feasible and accessible for people affected by Parkinson’s.

 What if something goes wrong?

If you have any concerns about any aspects of the study, you can contact the Chief Investigator, Mihalis Doumas (see below for contact details). Should you remain unhappy and wish to make a formal complaint, you can contact the Research Governance Team at Queen’s University Belfast (Telephone: 028 9097 2529; Email: researchgovernance@qub.ac.uk) or the North East – Newcastle & North Tyneside 2 Research Ethics Committee (Telephone: 0207 104 8082).

 Will my taking part in this study be kept confidential?

Yes, all information provided by you during the course of the research will be kept strictly confidential, and your data will be anonymised. Completed consent forms and pre-screening questionnaires containing confidential information will be stored securely in a locked office at Queen’s.

Please note that there are limits to this confidentiality. If you disclose information that indicates that you are at risk of harming yourself or others, or in danger of being harmed by someone else, the researchers will be legally obliged to pass this information on to your GP. You will be required to provide the contact details of your GP prior to taking part in this study so that we can notify them of your intended participation.

Queen’s University Belfast is the sponsor for this study based in the United Kingdom. We will be using information from you 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. Queen’s University Belfast will keep identifiable information about you for 5 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.

What will happen to the results of the research?

Information from this study may be presented at psychological conferences and published in academic journals. You will not be identifiable in any report or publication that results from this work. We also intend to provide participants with a summary of the results after we have completed our analysis within one year.

Who is organising and funding the research?

Queen’s University Belfast is sponsoring this research, which is being undertaken for Anna Carapellotti’s Ph.D. dissertation. Dr Mihalis Doumas and Dr Matthew Rodger of the School of Psychology will supervise this project. The research is being funded by Queen’s University Belfast’s School of Psychology, Sport NI, and the Thouron Award, a U.S.-U.K. graduate exchange scholarship.

Who has reviewed the study?

This study has been reviewed by the North East – Newcastle & North Tyneside 2 Research Ethics Committee.

 Contact for Further Information

If you would like to discuss any aspect of the study, or if you have any questions about it, please contact:

Postgraduate student, Anna Carapellotti at acarapellotti01@qub.ac.uk or 0044 2890 976500.

You may also contact Dr Mihalis Doumas at m.doumas@qub.ac.uk or 0044 28 9097 4605

Thank you for your interest in this study and for taking the time to read through this information sheet.