About the trial

How is the study structured?

The study will consist of four groups, one of which you would be assigned to. These groups will be structured so that they each test the effectiveness of different treatment conditions:

Pressure 1 vs Pressure 2

Less frequent (3x per week) vs More frequent (5x per week)

Shorter term (6 weeks) vs Longer term (12 weeks)

What will I do as a participant?

As a participant, you would need to come in for one in-person visit before you start the treatment, and then one visit after you finish the treatment. However, you may also get the chance to opt into two sub-studies, which would each require an additional visit before and after the treatment. Details of the first three visits are provided below - and the three visits at the end of treatment will be roughly the same.

In addition to these in-person visits, we will have a researcher call you each week to check that everything is going well with the treatment, and we will have a final check-up call six months after the treatment has ended to see how you are doing and whether any improvements to fatigue levels have persisted.

Visit 1

WHERE:

Biomedical Research Centre, Royal Hallamshire Hospital

WHAT:

Confirmation of eligibility (see Am I eligible?)

Consent form

Medical history (including current medications) taken

Questionnaires assessing fatigue and health (see FAQs)

Take blood pressure and (optional) blood samples to assess inflammation

6-minute walk test to assess physical capacity

RIC demonstration

Google Fitbit explanation and demonstration

Provision of RIC instructional brochure, treatment diary, and symptom diary

Provision of personal RIC pressure cuff and Google Fitbit

First RIC treatment carried out by the participant

HOW LONG:

Approximately 2 hrs total

Visit 2 (Optional)

WHERE:

University of Sheffield Imaging Facility, C Floor, Royal Hallamshire Hospital

WHAT:

MRI-specific consent and eligibility form

30-minute MRI scan for each leg to assess muscle energy levels and metabolism

HOW LONG:

Approximately 1.5 hrs total

Visit 3 (Optional)

WHERE:

Advanced Wellbeing Research Centre, Attercliffe

WHAT:

Measurement of height and weight

Explanation of the cardiopulmonary exercise test (CPET)

Fitting of the CPET gas analyser mask

CPET exercise bike test to assess energy metabolism/respiration and physical fitness (likely to last 10 mins)

HOW LONG:

Approximately 1.5 hrs total

Report abuse