Q: If I take part in MAGENTA, will this change the timing, location or frequency of appointments?

A: Taking part in MAGENTA should not change the timing, location or frequency of appointments.

Q: Who would I see for Activity Management or Graded Exercise therapy?

A. The therapist you see depends on where you live and sometimes, which treatment you are allocated. In some cases, the therapist provides both Graded Exercise Therapy and Activity Management. In other cases, the type of therapy you get, is provided by different therapists (for example physiotherapists are more likely to provide Graded Exercise Therapy). We try and make sure that you shouldn’t need to travel further because of getting one type of treatment compared to another.

Q: How long does the study last?

A: You will get treatment for as long as you or your child needs it. Sometimes children get better quickly and they do not need any more treatment. In these cases, we would still ask that you completed questionnaires at follow up. The last follow up questionnaire is at 12 months so your child will be in the study for 12 months.

Q: How often do we get questionnaires?

A: Parents/carers will receive questionnaires when their child first join the study, then at 6 months and 12 months after the start of the study. Young people will receive questionnaires at 6 months and 12 months. 

Q: Is the accelerometer easy to use?

A: Yes it is easy to use.

Q: I don’t want to wear the accelerometer, does this mean I cannot do the study?

A. We are using accelerometers to find out whether exercise changes in each treatment group and whether the change in exercise tells us about whether you will get better. But wearing the accelerometer isn't the most important bit of the study so if you want to take part, but do not want to wear the acceleromenter that is fine. 

Q: How would you decide what treatment to give if they aren’t in the study?

A: We would see which treatment you preferred and try and give you that treatment. The reason we are doing this study is because we do not know which treatment is the best for you or your child.

Q: Is one of the treatments a group treatment?

A: All the treatments are individual treatments.

Q: How much exercise is involved in the GET treatment?

A: The exercise is entirely dependent on what you are able to do. We will do a very careful assessment of the physical activity that you can do on a good day and a bad day and then set a level that is very safe for you and is probably about half of what you do on a good day. For quite a lot of children, this means they feel as though they are reducing exercise at the start. Once you are stable, the exercise is very slowly increased.

Q: At the moment she doesn’t go to school, does this matter?

A: We don’t think you should be part of the trial if you are severely affected. If you are severely affected you will not be leaving the house apart from medical appointments and will probably need help with self-care. There are lots of reasons why children don’t go to school. You can be part of MAGENTA if you are mild or moderately affected whether or not you go to school.

Q: I am about to do my A levels, does that mean I shouldn’t do the study?

A: It is fine for you to do the study whatever is happening at school if you want to. 

Q: why are you doing this trial?

A: Children and their parents in our service want to know whether Graded Exercise Therapy (GET) works, and whether it is safe. NICE (the body that recommends treatment in the NHS) says we should offer GET and other treatments (CBT and Activity Management) for children with CFS/ME but we don’t know if it works for children with CFS/ME. We know it can be helpful for adults with CFS/ME.

Q: What do children and parents think about GET?

A: We have interviewed children and their parents about both GET and Activity Management and they like both treatments.

Q: I have read that GET is harmful. Is that true?

A: No, so long as it is provided by appropriately trained healthcare professionals, as it is in this study. There is no evidence from research studies that GET is harmful. The most robust study to look at this was a review published in 2015 by a Cochrane Collaboration review group. In this review, the researchers looked at the data from all the trials investigating exercise therapies. They analysed data from 8 trials which included 1518 people. They concluded: “Exercise therapy was not found to worsen symptoms for people with CFS, while serious side effects were rare in all exercise and comparison groups”.

You can download copies of the review here:

Cochrane Collaboration Review (PDF, 942kB)

Cochrane Collaboration Review Abridged Version (PDF, 2,105kB)

Q: I understand that so far, the trials investigating GET have been in adults. What about children?

A: CFS/ME is different in adults and children. Children are much more likely to recover than adults, are less likely to have problems with anxiety or depression and often have different symptoms. At the moment, there are no trials investigating GET as an outpatient treatment which is why MAGENTA is so important for children with CFS/ME.

Children with CFS/ME want to know if GET might help them. This is very important for children who develop CFS/ME in the future. We also need research to know whether GET is value for money.

Q: How can you be sure that MAGENTA is not harming patients?

A: We take patient safety very seriously. We have a Data and Safety Monitoring Committee, which is independent of researchers conducting the study. They have reviewed all the evidence for adverse events and deterioration in health and have concluded that no treatment in the MAGENTA trial is harming patients. It is important to remember that both GET and Activity Management are treatments that are recommended for the NHS. Lots of children currently receive these treatments whether they are in a trial or not.

Q: Why do some patients say that GET has harmed them?

A: It is true that some adults with CFS/ME think that GET has made them get worse. This could be for several reasons. CFS/ME is a fluctuating illness with or without treatment. Many patients tell us that they got worse without treatment. We need trials to work out if benefit or harm is due to the treatment or the illness.

In some cases, people have been simply told to do more exercise and have been told this is GET. It isn’t. For many children, GET is about doing less exercise to begin with and then increasing slowly. It is very important that you receive GET from appropriately trained healthcare professionals who can provide GET as it should be provided. 

Q: What level of funding has been provided?

This is part of an NIHR Senior Research Fellowship funding a programme of work for paediatric CFS/ME. The total award is: £864736. 

 

Here are some other articles that discuss treatments for CFS/ME:

A UK based review of recommendations regarding the management of chronic fatigue (PDF, 356kB)

‌Online survey to explore outcomes of rehabilitation for CFSME (PDF, 181kB)