King's College London

Research portal

Mrs Sarah Evans

Research interests

 

Evaluation of Physical Activity Monitoring in Muscle Disease

 

We would like to invite you to take part in our research study, as part of an MRC funded PhD. Before you decide whether to volunteer, we would like you to understand why the research is being done and what it would involve for you. Please take time to read the following information and talk to others about the study if you wish. Please ask if anything is unclear or you require further information.

 

What is the purpose of the study?

Certain lifestyle behaviours, like good sleep and regular physical activity, are thought to confer health benefits. People with muscle disease, who experience some progressive disability, muscle weakness, fatigue or pain, may have difficulties getting enough rest or being physically active. However, physical activity is made up of all movements in our daily lives. It is, therefore, important to measure activity and inactivity in people with muscle disease to improve understanding and advice about exercise and rest.

The aim of this study is to test the ability of a questionnaire (MIPAQ) to effectively measure activity in adults with muscle disease.

A second, optional part of the study, is aimed at discovering whether self-monitoring using a Fitbit helps people to complete the activity questionnaire more accurately.

 

Why have I been invited to take part?

You have been invited to take part because you responded to the online advertisement. We are seeking volunteers in the UK, aged 18 years or older, with a diagnosis of progressive muscle disease, including:

  • Facioscapulohumeral Dystrophy (FSHD)
  • Limb Girdle Muscular Dystrophy (LGMD)
  • Miyoshi Myopathy (MM)
  • Oculopharyngeal Muscular Dystrophy (OPMD)
  • Becker’s Muscular Dystrophy (BDM) including manifesting female carriers
  • Duchenne’s Muscular Dystrophy (DMD) including manifesting female carriers
  • Congenital Muscular Dystrophies (CMD) (such as LAMA-2 and Collagen-IV)
  • Inclusion Body Myositis (IBM)
  • Myotonic Dystrophy (DM)
  • Emery Dreifuss Muscular Dystrophy
  • GNE myopathy
  • Centronuclear myopathies (and other progressive congenital myopathies)

 

What will happen if I take part?

If you choose to take part in the study, you will be asked screening questions about your diagnosis and how it has been confirmed. Your ability to take part and your preferred mode of communication will also be checked. Participation will take place remotely, you will not be asked to attended appointments.

As part of participation, you will be asked to provide demographic information including diagnosis, age, height, weight, usual mobility and occupation. You will also be asked to complete 2 entry questionnaires, one brief, about how you see yourself (Physical Self-Description Questionnaire) and a longer one about your quality of life (INQoL).

After entry information had been collected, the activity monitoring period will begin. In the first and second week you will be asked to fill in 2 activity questionnaires, electronically (or by post or phone if you prefer), each taking under 5 minutes to complete, one about function (HAQ) and one about your activity (MIPAQ). You will then be sent, by post, an activity monitor to wear on your ankle (or wrist if you prefer). After wearing the monitor for a week, you will be required to send it back in a provided pre-paid envelope and complete the MIPAQ once again. After 9 months the activity monitor will be sent to you again to wear for a week and you will be asked to update your demographic information and complete the activity questionnaires for the last time.

Nothing will be required of you in the 9-month period between the baseline measurements in the first month and the final week of follow up. However, within this period you will be invited to take part in an optional second part of the study, involving wearing a Fitbit for activity self-monitoring. If you decide to take part in this bit of the study, the purchase price of the Fitbit will be funded by the study and the researcher will help you to set up the device. You will be required to give the researcher access to your Fitbit data over a 2-week period. At the end of both weeks in this period you will be asked to complete the activity questionnaires again. Your Fitbit data will also be accessed by the researcher for a week at follow up. The Fitbit will be yours to keep at the end of the study.

 

Do I have to take part?

Participation is completely voluntary. You should only take part if you want to and choosing not to take part will not disadvantage you in anyway. Once you have read the information sheet, please contact us if you have any questions that will help you make a decision about taking part. If you decide to take part we will ask you to sign a consent form and you will be given a copy of this consent form to keep.

 

Incentives

If you elect to take part in the optional part of the study, you will get your own Fitbit to keep. A device worth around £100.

 

What are the possible risks of taking part?

If you have a skin allergy you might experience a rash after wearing an activity monitor on your ankle or wrist. Although most people do not have rashes or discomfort, you might find wearing an activity monitor uncomfortable, these symptoms settle on removal.

 

What are the possible benefits of taking part?

If you take part, you will be making a valuable contribution to ongoing research into muscle disease. Many people also find that a raised awareness of their physical activity and sleep patterns can be beneficial.

 

What if I change my mind about taking part?

You are free withdraw at any point of the study, without having to give a reason. Withdrawing from the study will not affect you in any way. You are able to withdraw your data from the study up until 31st December 2020,after which withdrawal of your data will no longer be possible because data will be committed to the final report. If you choose to withdraw from the study, we will not retain information about your self-perception or quality of life information you have given thus far. However, in order for the research to be reliable and accurate it is important to faithfully report the characteristics of any who chose to withdraw. Thus, if you withdraw from the study, we will keep anonymised demographic and activity level information already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible.

 

How is the project being funded?

This study is being funded by a Medical Research Council (MRC) PhD studentship at King’s College London.

 

What will happen to the results of the study?

The results of the study will be anonymised and summarised in a PhD thesis, peer reviewed scientific journals and/or at scientific conferences. Published research will be available online and by application to the KCL and British Libraries. No identifiable personal information will be published about you.

 

Who should I contact for further information?

 If you have any questions or require more information about this study, please contact me using the following contact details:

 

Name:           Sarah Roberts-Lewis (Physiotherapist)

E-mail:          sarah.roberts-lewis@kcl.ac.uk

Telephone:   020 7848 7862 (Work Mobile 07593 55 33 62)

Address:       Addison House, King’s College London, Guy’s Campus, London, SE1 1UL

 

Thank you for reading this information and for considering taking part in this research.

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