MAGENTA: Managed Activity Graded Exercise in Teenagers and Pre-Adolescents
Why are we doing this study?
We want to test whether a treatment that we use for CFS/ME called “Graded Exercise Therapy” is effective and value for money. We want to compare this with “Activity Management” which we also use for CFS/ME. We also want to find out more about Graded Exercise Therapy and Activity Management and whether young people think they are “OK” treatments. Current update: MAGENTA closed to recruitment in March 2018 with the successful recruitment of over 230 participants to the trial. MAGENTA remains the largest paediatric CFS M/E trial in the UK.
Who are we asking to take part?
We are asking young people to take part who are aged between 8 and 17 years and have a diagnosis of CFS/ME from the CFS/ME specialist unit. If the young person is unable to attend CFS/ME hospital appointments (e.g. you cannot leave the house), or any of the appointments required for the research study, we do not feel that they should take part. This study is voluntary and young people do not have to take part. If they do decide to participate, they can leave the study at any time and this will not affect the standard of specialist medical care they will receive.
What will the young person be asked to do if they take part?
We have an information sheet which provides an overview of the study. This can be found in the Participant Information Sheets section.
If the young person is interested in taking part, they will speak to a member of the research team who will explain the study to the young person and their parents/carers, and answer any questions they may have. If they want to take part in the study, they will be asked to fill in an assent or consent form to show us that they agree. You can find copies of our consent form in the Participant Information Sheets section.
Participants agreeing to take part will be given one of two treatments at random, either Activity Management or Graded Exercise Therapy (GET). We need to make sure that those in both groups are matched. This is the only way we can compare the groups and make sure the study is fair. Half of those taking part in the study will have Activity Management and half will have Graded Exercise Therapy (GET). The chance of getting either group is 50%. These are both treatments we currently use in our service and lots of children have already tried them.
Both groups will be seen in the specialist service and will get lots of advice about how to improve their sleep and they will get treatment for their symptoms. We will probably see participants 8-12 times in clinic.
Participants in this group will have a detailed assessment of the activity they do. This includes thinking activity such as school work, homework, time on the computer and screens, reading and hobbies that require concentration and physical activity such as walking or PE. We call this high energy activity. We will ask participants to record their activity on paper or our iPhone app “ActiveME”. We will then help them find their “baseline” activity which is the average amount of activity that they can do each day. When they have found their baseline activity, they will help them increase this by 10-20% each week. This is called activity management.
Graded Exercise Therapy
Participants in this group will receive a detailed physical assessment including how far they can walk in 2 minutes and how many times they can move from sitting to standing in one minute. This will help us set a safe exercise programme. Participants will be asked about the exercise they do each day and will be helped to find their exercise baseline. The baseline is the average amount of exercise they do each day. It will be less than they do on a good day. When they have found their baseline, we will ask participants to slowly increase their exercise. When they are able to do 30 minutes each day, we will increase the intensity of exercise. participants will be asked to record exercise using either charts or the iPhone app ActiveME. They will not be asked to record other activities, only exercise. To make sure participants do not over do their exercise, we will ask them to use a heart rate monitor.
An information sheet about GET can be found in the Participant Information Sheets section.
What is the difference between Activity Management and Graded Exercise therapy (GET)?
Activity Management will mainly be working on activities that take up most of the day like school work. It does not focus on exercise or include a physical assessment or heart rate monitoring. Graded Exercise Therapy gives detailed advice about exercise with an assessment of exercise and uses a heart rate monitor. Graded Exercise Therapy will not ask participants to monitor other activities such as school work.
What else will participants be asked to do?
We will ask participants and their relative to complete questionnaires at the beginning of the study, 6 months later and then 12 months later. You can see examples of the study questionnaires in the Questionnaire and Topic Guides section of this site. All the information given to us is completely private and will not include identifiable information like your name.
We will ask participants to wear an accelerometer to measure exercise at 3 time points: at the beginning of the study and 3 and 6 months later. This is a small box that participants will wear on a band around their hips. Lots of young people have used these to measure exercise. We may ask participants to record when they wear it and when you take it off. You can find the acceleometer information leaflet in the Participant Information Sheets section.
A researcher will also make contact with participants to arrange a time to talk with them and their parents (separately or together). Participants can be interviewed using Skype or face to face in clinic. The interview will involve asking questions about mood and activities that change mood in young people. For example, whether participants drink alcohol or take drugs. For most people, this discussion will take less than an hour.