ADAPT Trial

Why have I been invited to take part?

• The ADAPT trial is looking to recruit people diagnosed with rheumatological diseases who are currently experiencing fatigue that affects their daily life. You have been invited because you may fit these criteria.
   

I have a health condition and/or I’m taking medication that makes it difficult to exercise, is it safe for me to take part?

• We ask everyone to complete an online screening questionnaire which includes questions about your current health, medications and mobility. This will help us determine if you are eligible to take part in the trial. Following this, a member of the research team will get in touch with you via email and/or telephone to discuss in more detail any symptoms that you have raised.
• Our research team clinicians may review your answers and then may ask you to confirm with your GP that it is safe for you to participate. For more serious problems (for example, chest pain) we may ask for written approval from your own GP before you can participate.  
• The exercise classes are specifically adapted for people with chronic diseases and the instructor will offer modifications to suit every level of ability.
   

I have mobility difficulties, can I still take part?

• We will ask you questions at the expression of interest stage to determine any accessibility requirements for attending the class. This could include questions such as if you require seated-only classes, if you are able to stand and if you can move from seated position to lying down. Both the Pilates and Tai Chi classes will be adaptable to most levels of ability, including those who cannot get onto the floor for floor-based exercises. You may have to wait until an appropriate class is timetabled.
   

Do I have to travel anywhere to take part?

• No, you do not have to travel anywhere to take part in the trial. You will complete online questionnaires that can be completed via your smartphone/tablet/laptop.
• If you are randomly assigned to receive the Pilates or Tai Chi classes, these will be delivered remotely and can be accessed from the comfort of your own home via your smart phone/tablet/laptop, provided you have Internet access.
   

Do I need a computer, mobile phone or WiFi / internet access to take part?

• Yes, you will need to have a device that connects to the Internet (such as smartphone, tablet or laptop). The exercise classes are delivered online, accessible via a unique “Zoom” URL link. If you are unsure how to use Zoom, we can help you get set up.
• All questionnaires will be completed online. You can request paper copies of the questionnaires if you would prefer.
   

If I sign up to the trial, what will I have to do?

• You will complete an online screening questionnaire about your current health, medications and mobility. Following this, a member of the research team will get in touch with you via telephone to discuss in more detail any symptoms that you have raised and confirm your eligibility. We may ask you to provide you to provide written approval from your own GP before you can participate.  

You will be randomly allocated (by computer) to one of three groups:

1. Pilates: 1hr online class, twice a week for 8 weeks total
2. Tai Chi: 1hr online class, twice a week for 8 weeks total
3. Control: no classes

You will receive links to complete online questionnaires about your health and wellbeing at four time points: baseline, 8 weeks, 16 weeks and 6 months after joining the trial.

Please see our participant information sheet for full details of what is involved [link].

If I sign up to the trial, will I definitely receive Pilates or Tai Chi classes?

• If you are eligible to participate in the trial, you will be randomly allocated (by computer) to one of three groups until we reach our recruitment target. The group you are allocated to is determined by chance. You have an equal chance of being allocated to

1. Pilates group
2. Tai Chi group
3. Control group – no classes

• If you have been randomly allocated to the control group you are still an important part of the trial and making a valuable contribution to helping us answer our research question, by allowing us to have a comparison group. Upon completion of the trial you will receive access to online exercise videos, a mental health in rheumatology support video and links to support organisations
   

What days/times will the classes be?

• We will offer a range of days/times and you will be able to select your preferences when signing up to the trial. Classes will be held in the afternoons/early evening, Monday to Thursday.
   

How regular are the exercise classes?

• If you have been randomly allocated to either the Pilates order Tai Chi groups, classes are scheduled twice a week over an 8-week period.
   

I’ve never done Pilates or Tai Chi before, do I need previous experience?

• No experience required! Classes are welcome to everybody and suitable for absolute beginners.
   

What if I experience a disease flare during the trial?

• We understand that the nature of systemic autoimmune rheumatic diseases means your ability to do certain movements may fluctuate over the course of the 8-week classes and the class instructors will accommodate for this. Our general rule with any symptom arising is “if in doubt, sit it out”. We will still encourage people to attend and engage with the classes for the social and wellbeing element.
   

What are the possible risks of taking part in the trial?

• The following risks, although unlikely, need to be considered:
• The physical activity course will be gentle and adapted to people with chronic diseases, but any activity may cause problems or injury in anyone. In the case of minor injuries, you will be allowed to continue with the class but should avoid movements which cause pain.
• In the unlikely event of a significant injury during the class, you will be advised to stop the activities and directed to seek medical advice from your usual care provider i.e. your GP. You may be able to rejoin the classes later if deemed appropriate by your care provider.
• Our priority is your mental and physical health. Prior to starting the trial, you will complete an online form to tell us about your physical and mental health. Depending on what you have written and whether some types of physical activity may not be recommended for you, we may ask for written approval from your own doctors before you can participate.  

 Do you offer female-only exercise classes?

• We understand that some people may be more comfortable in a single sex class, and we will have classes that are female-only (including the instructor), and mixed. You can choose which you prefer when completing the expression of interest form.

Is my data safe?

• All information about you (including your personal data) will be stored securely with access restricted to authorised members of the research team from the University of East Anglia, University of Cambridge and King’s College London. If you are assigned to the Pilates or Tai Chi groups then the exercise provider will have access to your basic contact information (name, telephone number, email) and any medical information that you provided within the screening questionnaire that is relevant to your safety in the class, e.g. if you have a heart condition. Only these people will access your personal data as they need to manage your participation in the trial or audit the data collection process.
• We will use direct quotes from some peoples’ questionnaire responses and qualitative interviews in the write-up of the study. These will be labelled with a unique trial identification number and no names will be included. The published results will not include any information that could identify individuals.
• Further information about how the University uses personal data can be found at: https://www.information-compliance.admin.cam.ac.uk/data-protection/research-participant-data
   

Who will be providing the group exercise classes?

• The exercise classes will be delivered by fully qualified instructors (2 for Pilates and 2 for Tai Chi). Instructors were carefully selected by the research team and a team of volunteer patients on the basis of their skill level, experience with clients with chronic diseases and empathy.
   

How long will the trial last and what is my time commitment?

• The overall trial will last for 2 years. However your active involvement in the trial will be shorter. If you are eligible to take part, it will take approximately 6 months from the time that you provide your consent and complete baseline questionnaire, to the final follow-up questionnaire.
• If you are assigned to the exercise class groups, the classes will run for a total of 8 weeks (2x classes per week), followed by another 8 weeks of optional classes (1x class week).
   

Will I get paid for taking part?

• No, participants will not receive payment for taking part in the trial.
• We anticipate the information gained from this trial will help inform doctors and researchers about the impacts of sociable online exercise classes on people with systemic autoimmune rheumatic diseases. You will be contributing to research that aims to improve the lives of people with systemic autoimmune rheumatic diseases.
   

Where will I be able to find the overall results of the trial?

• A lay summary of the results of the trial will be sent to participants and published on the trial website. The results will be available after April 2027, once data collection and analysis is complete.
   

Where can I find further information about the trial?

• Please view our participant information sheet here [link to PIS tab] or contact us using the details provided here [link to ‘contact us’ tab].
   

I would like to take part in the ADAPT trial, what should I do next?

• If you are interested in taking part in the trial, please take your time to review the participant information sheet [link] then complete the screening questionnaire here [link]. Once you have completed the online questionnaire, someone from the research team will contact you via email or telephone to confirm eligibility and answer any questions you may have.

News will be updated as the study is officially launched.