Documentation of Informed Consent to Participate in Research
Project Title:Assessing the Impact of Internet-Guided Pilates Training on People with Hypermobile Ehlers-Danlos Syndrome or Hypermobility Spectrum Disorder (hEDS/HSD)

Leslie Russek, PT, DPT, PhD, OCS; Jeannie Di Bon; Jane Simmonds PT Prof D, MA MSCP

Institutional Review Board (IRB) approval
number: 19-48.1 Approval valid until: No expiration
You have been asked to be a part of the research described here. Participation is voluntary.
Summary of the study: This study is trying to find out whether an on-line Pilates course “Strengthen Your Hypermobile Core”can benefit people with hEDS/HSD.Subjects will complete a series of on-line questionnaires asking about pain, function, and quality of life; these questionnaires will take 30-45 minutes. You may pause and return to the survey later. The questions are easier to read and answer on a computer or tablet (rather than a phone); if you are currently using a phone, you may want to switch to a computer.

Subjects will then either be be given (free) access to the on-line Pilates course immediately, or placed on an 8-week wait list before gaining access to the Pilates course. The Pilates course includes 5 modules that each last about 25 minutes; you should try to do 3 modules per week for 8 weeks. These Pilates exercises are slow, gentle movements that focus on body awareness, breathing, slow controlled movement, and relaxation; they are done lying down, sitting in a chair, or standing. We will contact you weekly to check on your progress, and ask if you have any comments or concerns.

You will repeat the questionnaires after 8 weeks of doing the Pilates, and again 6 months later. While discomfort or injury are unlikely, these are always possible with a new exercise program. You may omit any exercise or movement that causes discomfort and should not do anything that you feel is not safe for you. Your privacy will be protected because survey data will be stored using an identification code that only you know; once your data collection is complete, your email address will be removed from the data and it will not be possible to link you to the data.
Please answer a few questions to make sure you are eligible to participate in this research. If you are eligible, please read the material below before deciding if you consent to participate in this study.

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* 1. Have you been diagnosed one of the following conditions by a health care provider? 
a.    Hypermobility Syndrome Disorder (HSD),
b.    hypermobile Ehlers-Danlos Syndrome (hEDS),
c.    EDS type III (EDS-III/EDS-3),
d.    EDS-hypermobility type (EDS-HT),
e.    Hypermobility Syndrome (HMS),
f.     Joint Hypermobility Syndrome (JHS).

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* 2. Are you between 18-70 years of age?

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* 3. Do you read and speak English well enough to answer written questions and safely follow instructions given in English?

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* 4. Are you healthy enough to participate in the Pilates exercises included in this research, as described above? If you are uncertain, contact your health care provider for advice before continuing.