Managing Fatigue with physical ACTivity monitors (FACT study)
Research type
Research Study
Full title
Use of physical activity monitors and slow glucocorticoid taper by patients with polymyalgia rheumatica and large-vessel vasculitis experiencing fatigue: a feasibility study
IRAS ID
188984
Contact name
Sarah Mackie
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Patients with vasculitis and PMR have told us that fatigue impacts hugely on quality of life, and is often ignored by doctors. Walking is something that patients can do to help themselves that may help to reduce fatigue. Physical activity monitors allow patients to monitor their daily steps count, and may help to increase motivation. However, the feasibility and whether this is more effective than routine clinical care is unknown. Patient support groups have told us that doctors often try to reduce their steroids (glucocorticoids, GCs) dose too quickly. This may increase fatigue in patients who have adrenal suppression as a consequence of GCs treatment. A slow GCs dose reduction scheme may help to prevent this. However, this has never been studied. Therefore, the study aims to evaluate the feasibility of using activity monitors to promote regular walking, in combination with a slow GCs reduction schedule, for management of fatigue. Assessments will be completed on three separate visits. Visits one and three will take place following a routine clinical appointment at Wharfedale hospital. Visit two will be a separate research visit. Assessments will include body composition, blood sample, questionnaires, muscle strength and function tests. Between visits one and two, patients will be asked to wear two physical activity monitors for 7 days and to complete a simple diary to record daily steps taken. There will be an option to wear another monitor on the wrist during night time sleep to assess sleep quality. Between visits two and three, patients will either be asked to continue with their usual activities or to wear a physical activity device for three months and record the number of steps taken each day in a diary. If medically appropriate, the doctor will ask the patient to follow a slow GCs reduction scheme.
REC name
North East - York Research Ethics Committee
REC reference
16/NE/0007
Date of REC Opinion
19 Feb 2016
REC opinion
Further Information Favourable Opinion